Clinical studies



Elips

Elips

Active sites in Switzerland: Geneva-HUG, Lausanne-CHUV, Zurich, Bern
Study duration : 8 years
Start 2009, End : 2018
Property/Sponsor: HUG

Information program aimed at improving prevention and reducing the chances of recurrence for any patient hospitalized following an acute coronary syndrome and evaluating its impact through a study.

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Elips

Elips

Active sites in Switzerland: Geneva-HUG, Lausanne-CHUV, Zurich, Bern
Study duration : 8 years
Start 2009, End : 2018
Property/Sponsor: HUG

Information program aimed at improving prevention and reducing the chances of recurrence for any patient hospitalized following an acute coronary syndrome and evaluating its impact through a study.

Horizon

Horizon

Active sites in Switzerland: HUG, CHUV, Inselspital, Basel, Liestal
Study duration : ~ 3 years
Start in Geneva : september 2020
Property: Novartis Pharmaceuticals

Clinical trial to assess the impact of lowering Lp (a) on major cardiovascular events in patients with a history of cardiovascular disease.

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Horizon

Horizon

Active sites in Switzerland: HUG, CHUV, Inselspital, Basel, Liestal
Study duration : ~ 3 years
Start in Geneva : september 2020
Property: Novartis Pharmaceuticals

Clinical trial to assess the impact of lowering Lp (a) on major cardiovascular events in patients with a history of cardiovascular disease.

Clever ACS

Clever ACS

Active sites in Switzerland: Geneva-HUG, Bern-HUB, Lugano-Cardiocentro-Ticino, Zurich-HUZ
Start : january 2015
End : september 2021
Property: Université de Zurich, Swiss National Science Foundation, Novartis Pharmaceuticals

Zurich University, Swiss National Science Foundation, Novartis Pharmaceuticals Study on the short-term efficacy (5 days) of everolimus (Votubia on the Swiss market) on the size of the infarction, the scarring of the left ventricle and the inflammation compared to placebo in patients hospitalized with a myocardial infarction.

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Clever ACS

Clever ACS

Active sites in Switzerland: Geneva-HUG, Bern-HUB, Lugano-Cardiocentro-Ticino, Zurich-HUZ
Start : january 2015
End : september 2021
Property: Université de Zurich, Swiss National Science Foundation, Novartis Pharmaceuticals

Zurich University, Swiss National Science Foundation, Novartis Pharmaceuticals Study on the short-term efficacy (5 days) of everolimus (Votubia on the Swiss market) on the size of the infarction, the scarring of the left ventricle and the inflammation compared to placebo in patients hospitalized with a myocardial infarction.

Orion-16

Active sites in Switzerland: HUG, CHUV, Inselspital, Basel, Liestal
Expected duration of the study : ~ 2 years
Start in Geneva: January 2021
Property: Novartis Pharmaceuticals
Resp GEcor/HUG: Pr François MACH, Pr. Georg EHRET

Trial to evaluate the safety, tolerability and efficacy of inclisiran in adolescents (12 to less than 18 years of age) with familial hypercholesterolemia and high cholesterol (LDL-C).

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Orion-16

Active sites in Switzerland: HUG, CHUV, Inselspital, Basel, Liestal
Expected duration of the study : ~ 2 years
Start in Geneva: January 2021
Property: Novartis Pharmaceuticals
Resp GEcor/HUG: Pr François MACH, Pr. Georg EHRET

Trial to evaluate the safety, tolerability and efficacy of inclisiran in adolescents (12 to less than 18 years of age) with familial hypercholesterolemia and high cholesterol (LDL-C).

Clear synergy

International study
Expected duration of the study : ~ 5 years
Start in Geneva: August 2021
Property: NYU Langone Health
Resp GEcor/HUG: Pr François MACH, Dr. Quentin CHATELAIN

Randomized factorial 2×2 controlled trial to test the efficacy of colchicine and spironolactone on the incidence of CV events in patients with myocardial infarction and stented .

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Clear synergy

International study
Expected duration of the study : ~ 5 years
Start in Geneva: August 2021
Property: NYU Langone Health
Resp GEcor/HUG: Pr François MACH, Dr. Quentin CHATELAIN

Randomized factorial 2×2 controlled trial to test the efficacy of colchicine and spironolactone on the incidence of CV events in patients with myocardial infarction and stented .

Swiss TAVI Register

Swiss study
Expected duration of the study : ~ 14 years
Start in Geneva: 2011
Property: University Hospital Inselspital, Bern
Resp GEcor/HUG: Pr François MACH

National registry of patients with a TAVI (Transcatheter Aortic Valve Implantation).

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Swiss TAVI Register

Swiss study
Expected duration of the study : ~ 14 years
Start in Geneva: 2011
Property: University Hospital Inselspital, Bern
Resp GEcor/HUG: Pr François MACH

National registry of patients with a TAVI (Transcatheter Aortic Valve Implantation).

Pacific-AMI

International study
Study start : September 2020
Expected duration: 52 weeks
End of study: February 2022
Property: Bayer
Resp GEcor/HUG: Pr François MACH, Dr Juan F. IGLESIAS

Efficacy/safety evaluation study of BAY 2433334 (coagulation factor XI inhibitor. ) in patients with acute myocardial infarction, at increased risk of thrombosis, treated with double platelet anti-aggregation.

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Pacific-AMI

International study
Study start : September 2020
Expected duration: 52 weeks
End of study: February 2022
Property: Bayer
Resp GEcor/HUG: Pr François MACH, Dr Juan F. IGLESIAS

Efficacy/safety evaluation study of BAY 2433334 (coagulation factor XI inhibitor. ) in patients with acute myocardial infarction, at increased risk of thrombosis, treated with double platelet anti-aggregation.

Artesia

International study
Study start : 2016
Property: Population Health Research Institute (CA), Pfitzer, Medtronic, Bristol- Myers Squibb, Canadian Institutes of Health Research.
Resp GEcor/HUG: Pr Haran BURRI

Clinical study comparing the effects of aspirin and the anticoagulant Apixaban and evaluating the incidence of stroke and systemic embolism in patients with atrial fibrillation.

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Artesia

International study
Study start : 2016
Property: Population Health Research Institute (CA), Pfitzer, Medtronic, Bristol- Myers Squibb, Canadian Institutes of Health Research.
Resp GEcor/HUG: Pr Haran BURRI

Clinical study comparing the effects of aspirin and the anticoagulant Apixaban and evaluating the incidence of stroke and systemic embolism in patients with atrial fibrillation.

His-PACE

Local study (HUG)
Study start : April 2021
Expected duration : 2 years
End of study: June 2023
Property: HUG
Resp GEcor/HUG: Dr Elise BAKELANTS, Pr Haran BURRI

Comparison of two pacing methods on cardiac function and quality of life. Namely, the pacemaker or the internal defibrillator with a lead positioned on the His bundle.

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His-PACE

Local study (HUG)
Study start : April 2021
Expected duration : 2 years
End of study: June 2023
Property: HUG
Resp GEcor/HUG: Dr Elise BAKELANTS, Pr Haran BURRI

Comparison of two pacing methods on cardiac function and quality of life. Namely, the pacemaker or the internal defibrillator with a lead positioned on the His bundle.

CONSPIRE

International study
Study start : April 2021
Expected duration : 1 to 5 years
Property: University of Chicago, Biotronik SE & Co. KG
Resp GEcor/HUG: Pr Haran BURRI

Collecting information on routine clinical practices and devices used to treat cardiac rhythm disorders.

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CONSPIRE

International study
Study start : April 2021
Expected duration : 1 to 5 years
Property: University of Chicago, Biotronik SE & Co. KG
Resp GEcor/HUG: Pr Haran BURRI

Collecting information on routine clinical practices and devices used to treat cardiac rhythm disorders.

DISCO RADIAL

EU-Japan Collaboration
Study start : November 2019
Property/Sponsor: Terumo Europe N.V.
Resp GEcor/HUG: Dr Juan F. IGLESIAS

Study with the objective of demonstrating the superiority of the DTRA (Distal Radial Access) system over the CTRA (Conventional Transradial Access) system in cases of radial artery occlusion of the forearm.

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DISCO RADIAL

EU-Japan Collaboration
Study start : November 2019
Property/Sponsor: Terumo Europe N.V.
Resp GEcor/HUG: Dr Juan F. IGLESIAS

Study with the objective of demonstrating the superiority of the DTRA (Distal Radial Access) system over the CTRA (Conventional Transradial Access) system in cases of radial artery occlusion of the forearm.

SWISSHEART Failure Network

International study
Study start :2022
Expected duration: 5 years
Property: Swissheart
Resp GEcor/HUG: Pr François MACH, Dr David Carballo

Creation of diagnostic scores and cardiovascular risks thanks to machine learning. Calculated on the basis of data from patients with acute heart failure (AHF), or acute coronary syndrome (ACS).

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SWISSHEART Failure Network

International study
Study start :2022
Expected duration: 5 years
Property: Swissheart
Resp GEcor/HUG: Pr François MACH, Dr David Carballo

Creation of diagnostic scores and cardiovascular risks thanks to machine learning. Calculated on the basis of data from patients with acute heart failure (AHF), or acute coronary syndrome (ACS).

The Geneva Covid-19 CVD study

Participation in the European Register
Study start :2021
Property: HUG
Study completion : July 31, 2021
Resp GEcor/HUG: Pr François MACH, Dr Elena TESSITORE

Retrospective observational study to compare the short-, medium- and long-term prognoses and consequences of SARS-CoV-2 infections in hospitalized patients with or without pre-existing cardiovascular disease.

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The Geneva Covid-19 CVD study

Participation in the European Register
Study start :2021
Property: HUG
Study completion : July 31, 2021
Resp GEcor/HUG: Pr François MACH, Dr Elena TESSITORE

Retrospective observational study to compare the short-, medium- and long-term prognoses and consequences of SARS-CoV-2 infections in hospitalized patients with or without pre-existing cardiovascular disease.

Swiss Cardiovascular SARS CoV2 Consortium

Swiss Register
Start of study :2020
Property: HUG
Resp GEcor/HUG: Pr François MACH, Dr David Carballo

Study of the effects of SARS-COV-2 infection in patients hospitalized for acute cardiac pathology.

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Swiss Cardiovascular SARS CoV2 Consortium

Swiss Register
Start of study :2020
Property: HUG
Resp GEcor/HUG: Pr François MACH, Dr David Carballo

Study of the effects of SARS-COV-2 infection in patients hospitalized for acute cardiac pathology.

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ARVC

Swiss Register, Biobank
Start of study :2014
Expected duration : 10 years
Property : UZH
Resp GEcor/HUG: Pr Haran BURRI

ARVC for “Arrhythmogenic Right Ventricular Cardiomyopathy”
Determination of clinical and genetic factors in patients with arrhythmogenic right ventricular cardiomyopathy (ADVC).

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ARVC

Swiss Register, Biobank
Start of study :2014
Expected duration : 10 years
Property : UZH
Resp GEcor/HUG: Pr Haran BURRI

ARVC for “Arrhythmogenic Right Ventricular Cardiomyopathy”
Determination of clinical and genetic factors in patients with arrhythmogenic right ventricular cardiomyopathy (ADVC).

ECGi of SyncAV with MPP

2 centers in Europe
Expected duration : 2 years
Check out : Sep 2022
Resp GEcor/HUG: Dr Elise BAKELANTS, Pr Haran BURRI

Study in patients who have been implanted with a cardiac resynchronization device to evaluate the impact of multipoint stimulation (MPP) and SyncAV programming on ventricular electrical activation time and activation sequence.

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ECGi of SyncAV with MPP

2 centers in Europe
Expected duration : 2 years
Check out : Sep 2022
Resp GEcor/HUG: Dr Elise BAKELANTS, Pr Haran BURRI

Study in patients who have been implanted with a cardiac resynchronization device to evaluate the impact of multipoint stimulation (MPP) and SyncAV programming on ventricular electrical activation time and activation sequence.

IMODERN

Start : February 2019
Expected duration : 5 years
Suspension COVID
Resp GEcor/HUG: Dr Juan F. IGLESIAS

The iMODERN trial aims to compare an iFR-guided intervention of non-infarction lesions during the acute intervention with a CMR-guided delayed exercise infusion strategy during outpatient follow-up, to determine the optimal therapeutic approach for STEMI patients with multivascular lesions.

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IMODERN

Start : February 2019
Expected duration : 5 years
Suspension COVID
Resp GEcor/HUG: Dr Juan F. IGLESIAS

The iMODERN trial aims to compare an iFR-guided intervention of non-infarction lesions during the acute intervention with a CMR-guided delayed exercise infusion strategy during outpatient follow-up, to determine the optimal therapeutic approach for STEMI patients with multivascular lesions.

RADIANCE-2

International Register
Start : April 2021
Expected duration : 5 years
Property/Sponsor : ReCor Medical Inc.
Resp GEcor/HUG : Dr Juan F. IGLESIAS

Study to demonstrate the efficacy and safety of the “Paradise” renal denervation system in subjects with hypertension and taking 0 to 2 drugs at the time of consent.

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RADIANCE-2

International Register
Start : April 2021
Expected duration : 5 years
Property/Sponsor : ReCor Medical Inc.
Resp GEcor/HUG : Dr Juan F. IGLESIAS

Study to demonstrate the efficacy and safety of the “Paradise” renal denervation system in subjects with hypertension and taking 0 to 2 drugs at the time of consent.

Pioneer III

International Register
Start in Geneva : 2019
Expected duration : 5 years
Property/Sponsor : Sino Medical Sciences Technology (SINOMED)
Resp GEcor/HUG : Pr. Marco ROFFI

Study to compare the safety and efficacy of the biodegradable coronary stent BuMA Supreme from SINOMED on patients with up to 3 coronary lesions to coronary stents made of xience or promoted sustainable polymer.

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Pioneer III

International Register
Start in Geneva : 2019
Expected duration : 5 years
Property/Sponsor : Sino Medical Sciences Technology (SINOMED)
Resp GEcor/HUG : Pr. Marco ROFFI

Study to compare the safety and efficacy of the biodegradable coronary stent BuMA Supreme from SINOMED on patients with up to 3 coronary lesions to coronary stents made of xience or promoted sustainable polymer.

BIOSTEMI

Swiss Register (10 cantons)
Start in Geneva : September 2016
End of study : 2020
Study followed : up to 2023
Property/Sponsor : University Hospital Bern
Resp GEcor/HUG : Dr Juan F. IGLESIAS

The BIOSTEMI study aims to establish the superiority of third-generation ultrathin stents made of biodegradable polymers designed to improve vascular healing in patients with heart attacks who have undergone coronary angioplasty, compared to stents second generation in permanent polymers.

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BIOSTEMI

Swiss Register (10 cantons)
Start in Geneva : September 2016
End of study : 2020
Study followed : up to 2023
Property/Sponsor : University Hospital Bern
Resp GEcor/HUG : Dr Juan F. IGLESIAS

The BIOSTEMI study aims to establish the superiority of third-generation ultrathin stents made of biodegradable polymers designed to improve vascular healing in patients with heart attacks who have undergone coronary angioplasty, compared to stents second generation in permanent polymers.

SwissSCAD

HUG Register
Start in Geneva : June 2020
Duration of study : 10 years
Duration of follow-up : 5 years
Resp GEcor/HUG : Dr Sophie DEGRAUWE

The SwissSCAD registry is a large prospective observational cohort study to describe the natural history of spontaneous coronary artery dissection (SCAD), its results and treatments.

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SwissSCAD

HUG Register
Start in Geneva : June 2020
Duration of study : 10 years
Duration of follow-up : 5 years
Resp GEcor/HUG : Dr Sophie DEGRAUWE

The SwissSCAD registry is a large prospective observational cohort study to describe the natural history of spontaneous coronary artery dissection (SCAD), its results and treatments.

NATURE

Start : Early April 2022
Expected end date  : December 2024
Sponsor : Vesalio
Resp GEcor/HUG : Dr Juan F. IGLESIAS

“Thrombectomy Device as Adjunctive Reperfusion Modality in ST-segment Elevation Myocardial Infarction (NATURE)”
A prospective, multicenter, randomized clinical trial designed to evaluate the safety and efficacy of the enVast coronary thrombectomy system as a complementary measure to a conventional intervention in subjects with ST segment elevation myocardial infarction (STEMI).

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NATURE

Start : Early April 2022
Expected end date  : December 2024
Sponsor : Vesalio
Resp GEcor/HUG : Dr Juan F. IGLESIAS

“Thrombectomy Device as Adjunctive Reperfusion Modality in ST-segment Elevation Myocardial Infarction (NATURE)”
A prospective, multicenter, randomized clinical trial designed to evaluate the safety and efficacy of the enVast coronary thrombectomy system as a complementary measure to a conventional intervention in subjects with ST segment elevation myocardial infarction (STEMI).

DEFINE GPS

International Register
Start date  : 29 March 2022
Sponsor : Philips Clinical & Medical Affairs Global
Resp GEcor/HUG : Dr Juan F. IGLESIAS

Study comparing coronary angioplasty guided by angiography with coronary physiology guided angioplasty with iFR.

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DEFINE GPS

International Register
Start date  : 29 March 2022
Sponsor : Philips Clinical & Medical Affairs Global
Resp GEcor/HUG : Dr Juan F. IGLESIAS

Study comparing coronary angioplasty guided by angiography with coronary physiology guided angioplasty with iFR.

SELUTION DeNovo

International Register
Start date  : May 2021
Expected end : July 2028
Sponsor : M.A. Med Alliance S.A.
Resp GEcor/HUG : Dr Juan F. IGLESIAS

A clinical trial comparing the Drug Eluting Balloon (DEB) strategy with the Drug Eluting Stent (DES) strategy.

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SELUTION DeNovo

International Register
Start date  : May 2021
Expected end : July 2028
Sponsor : M.A. Med Alliance S.A.
Resp GEcor/HUG : Dr Juan F. IGLESIAS

A clinical trial comparing the Drug Eluting Balloon (DEB) strategy with the Drug Eluting Stent (DES) strategy.

BIOSOLVE-IV

HUG Study
Start date  : March 2019
End date : 1 January 2022
Sponsors : HUG, Biotronik AG
Resp GEcor/HUG : Dr Juan F. IGLESIAS

(Magmaris Swiss Satellite Registry)

This study will investigate the clinical performance and long-term safety of the resorbable “Magmaris” solution in a real-world setting and expand clinical practice using this technology in a nationally controlled registry.

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SELUTION DeNovo

HUG Study
Start date  : March 2019
End date : 1 January 2022
Sponsors : HUG, Biotronik AG
Resp GEcor/HUG : Dr Juan F. IGLESIAS

(Magmaris Swiss Satellite Registry)

This study will investigate the clinical performance and long-term safety of the resorbable “Magmaris” solution in a real-world setting and expand clinical practice using this technology in a nationally controlled registry.

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