Loading clinical trials...

HeartMate 3™ CE Mark Clinical Investigation Plan | Clinical Trials | Clareo Health

COMPLETEDNA

HeartMate 3™ CE Mark Clinical Investigation Plan

NCT02170363•Abbott Medical Devices

Summary

The purpose of this clinical investigation is to evaluate the performance and safety of the HeartMate 3 Left Ventricular Assist System (HM3 LVAS) To support obtaining CE Mark for the HM3 LVAS in Europe, a multi-center clinical study will be conducted in multiple countries. The clinical study will be conducted in compliance with the Declaration of Helsinki, ICH/GCP and EN ISO 14155:2011 Requirements for Clinical Investigations and in accordance with country-specific requirements, under one clinical study protocol. This study will evaluate the performance of the HM3 LVAS, side effects and undesirable conditions within acceptable risks and weigh them against the intended performance of HM3 LVAS in accordance with Essential Requirements 2, 5 and 16 of the Active Implantable Medical Device Directive 90/385/EEC (AIMDD).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient or legal representative has signed Informed Consent Form (ICF)
•2. Age ≥ 18 years
•3. BSA ≥ 1.2 m2
•4. NYHA IIIB or IV OR ACC/AHA Stage D
•5. LVEF ≤ 25%
•6. CI ≤ 2.2 L/min/m2, while not on inotropes
•7. Patients must also meet one of the following:
•\- On Optimal Medical Management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and are failing to respond,
•OR
•\- In NYHA class IIIB or IV heart failure for at least 14 days AND dependent on intraaortic balloon pump (IABP) for at least 7 days,
+5 more criteria

Exclusion Criteria

•1. Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy
•2. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator
•3. Existence of ongoing mechanical circulatory support (MCS) other than IABP
•4. Positive pregnancy test if of childbearing potential
•5. Lactating mothers
•6. Presence of mechanical aortic cardiac valve that will not be converted to a bioprosthesis at the time of LVAD implant
•7. History of any organ transplant
•8. Platelet count \< 100,000 x 103/L (\< 100,000/ml)
•9. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management
•10. History of confirmed, untreated AAA \> 5 cm in diameter
+16 more criteria

Locations (10)

The Alfred Hospital

Melbourne, Victoria, Australia

AKH Medical University of Vienna

Vienna, Austria

Toronto General Hospital

Toronto, Ontario, Canada

Institute for Clinical and Experimental Medicine (IKEM)

Prague, Czechia

Herz- und Diabeteszentrum NRW Thorax- und Kardiovaskularchirurgie Clinic

Bad Oeynhausen, Germany

Deutsches Herzzentrum Berlin

Berlin, Germany

Universitats-Herzzentrum Freiburg

Freiburg im Breisgau, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Herzentrum Leipzig GmbH

Leipzig, Germany

National Research Center for Cardiac Surgery

Astana, Kazakhstan

Key Dates

Start Date

June 1, 2014

Primary Completion Date

May 1, 2015

Completion Date

March 9, 2020

Last Updated

June 27, 2022

Enrollment

ACTUAL participants

Conditions

Advanced Refractory Left Ventricular Heart Failure

Interventions

Left Ventricular Assist System (LVAS)

DEVICE