MOMENTUM 3 Continued Access Protocol — MOMENTUM 3 CAP

Advanced Refractory Left Ventricular Heart Failure Clinical Trial

Official title:
Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ Continued Access Protocol: Post-Approval Continued Follow-up

Status Completed

Clinical Trial Summary

The objective of the study is to continue to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the the MOMENTUM 3 IDE Study.

Clinical Trial Description

Enrollment in the CAP cohort ended shortly after approval for the long-term indication was received from the FDA in October 2018. As a condition of approval, all patients enrolled in the CAP cohort were to complete the 2-year follow-up to fulfil a post-approval study requirement. ;

Study Design

Related Conditions & MeSH terms

Advanced Refractory Left Ventricular Heart Failure
Heart Failure

Clinical Trial Details

NCT number	NCT02892955
Study type	Interventional
Source	Abbott Medical Devices
Contact
Status	Completed
Phase	N/A
Start date	August 2016
Completion date	March 2021

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	`NCT02170363` - HeartMate 3™ CE Mark Clinical Investigation Plan	N/A
Completed	`NCT03982979` - MOMENTUM 3 Pivotal Cohort Extended Follow-up PAS