NCT01832610

Post- Approval Study on Patients Who Received a HeartWare HVAD® During IDE Trials

A Multi Center, Post Approval Study Providing Continued Evaluation and Follow-up on Patients Who Received a HeartWare® Ventricular Assist System During IDE Trials for the Treatment of Advanced Heart Failure

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 101 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients will be approached to participate in this PAS after the HeartWare® Ventricular Assist System receives PMA approval for the indicated use as a bridge to cardiac transplantation.

Detailed description

Patients who participated in prior trials will be approached for this PAS as follows: * Patients who are on continued HeartWare® System support, (original or exchange device) * Patients who have been explanted for transplant or recovery and have not yet completed 6 months of follow-up Patients who participated in prior trials who will not be approached to participate in this follow-up study include: • Patients who have been explanted for transplant or recovery and have completed at least 6 months of follow-up (documented in the prior IDE trial). No new patients are being screened or implanted with the HeartWare® System for this trial, it is a follow-up trial only.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	HeartWare® VAS	The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use.

Timeline

• Start date: 2013-01-01
• Primary completion: 2017-11-01
• Completion: 2018-03-01
• First posted: 2013-04-16
• Last updated: 2019-07-11
• Results posted: 2019-07-11

Locations

25 sites across 1 country: United States