CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 144 enrolled
Drug / intervention
HeartWare HVAD +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02268942
NCT02268942N/ACompleted
CompareCT.gov

A Prospective, Single-Arm, Multi-Center Study in Collaboration With INTERMACS to Evaluate the Thoracotomy Implant Technique of the HeartWare™ HVAD™ System in Patients With Advanced Heart Failure

Medtronic Cardiac Rhythm and Heart Failure·interventional·Posted Oct 20, 2014·Updated Dec 2, 2019

In Brief

A clinical study evaluating HeartWare HVAD and Thoracotomy for Left Sided Heart Failure. Completed, enrolled 144 participants across 26 sites in 2 countries.

Detailed Summary

This is a prospective, multi-center,single-arm study that will evaluate the thoracotomy implant technique in up to 145 subjects implanted via thoracotomy with the HeartWare HVAD System and enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs®) protocol and database. All participating centers are current INTERMACS® sites in good standing and follow the INTERMACS® protocol and procedures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeft Sided Heart Failure
CountriesCanada, United States
CollaboratorsINTERMACS

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 20, 2014
Enrollment StartNov 1, 2014
Primary CompletionOct 1, 2016
Study CompletionOct 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.7 years ago

Interventions

HeartWare HVADdevice

Implant of HeartWare HVAD via thoracotomy implant technique

Thoracotomyprocedure

Thoracotomy implant technique