HeartMate 3™ CE Mark Clinical Investigation Plan — HM3 CE Mark

Advanced Refractory Left Ventricular Heart Failure Clinical Trial

Official title:
HeartMate 3™ CE Mark Clinical Investigation Plan

Status Completed

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Advanced Refractory Left Ventricular Heart Failure
Heart Failure

Clinical Trial Details

NCT number	NCT02170363
Study type	Interventional
Source	Abbott Medical Devices
Contact
Status	Completed
Phase	N/A
Start date	June 2014
Completion date	March 9, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02224755` - MOMENTUM 3 IDE Clinical Study Protocol	N/A
Completed	`NCT04548128` - Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical SWIFT HM3 PMS
Completed	`NCT03022461` - HeartMate 3 CE Mark Study Long Term Follow-up
Completed	`NCT03982979` - MOMENTUM 3 Pivotal Cohort Extended Follow-up PAS
Completed	`NCT02892955` - MOMENTUM 3 Continued Access Protocol	N/A