Clinical trial NCT01832610: Post- Approval Study on Patients Who Received a HeartWare HVAD® During IDE Trials
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2013-04-16
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The patient population consists of patients who were at risk of death from refractory, advanced heart failure and implanted with a HeartWare® Ventricular Assist System under IDE G070199.

Patients must have participated as a study patient in a prior HeartWare trial under IDE G070199, and been implanted with the HeartWare® System

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. The patient has participated in a prior HeartWare trial under IDE G070199.
2. The patient was implanted with the HeartWare® Ventricular Assist System and was an active patient in the prior trial.
3. The patient has signed informed consent for participation in the study.

Exclusion Criteria:

1. The patient is unwilling or unable to comply with trial requirements.
2. The patient did not sign the informed consent.

Primary outcomes:
measure: Overall Survival on Device
timeFrame: Implant to 5 years
Secondary outcomes:
measure: Final Patient Status
timeFrame: Implant to 5 years
measure: Re-hospitalizations
timeFrame: Enrollment into HW-PAS-03 to 5 years
measure: Number of Participants Experiencing Any Adverse Event Per Intermacs Definition
timeFrame: Enrollment into HW-PAS-03 to 5 years
measure: Health Status Change Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: Change from baseline to 5 years
measure: Health Status Change Measured by EuroQol EQ-5D (Version 5L)
timeFrame: Enrollment to 5 years
measure: Change in Functional Status Measured by New York Heart Association (NYHA) Class
timeFrame: Change from baseline to 5 years
measure: Change in Functional Status Measured by 6-minute Walk
timeFrame: Change from baseline to 5 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida - Gainesville
state: Florida
city: Miami
country: United States
facility: University of Miami / Jackson Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: The Emory Clinic Inc.
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: IU Health Methodist
state: Indiana
city: Louisville
country: United States
facility: Jewish Hospital - Rudd Heart and Lung Institute
state: Kentucky
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University / Barnes Jewish Hospital
state: Missouri
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Hershey
country: United States
facility: Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas - South Western
state: Texas
city: Houston
country: United States
facility: Texas Heart Institute
state: Texas
city: Spokane
country: United States
facility: Northwest Cardiothoracic &Transplant Surgeons
state: Washington
Study officials:
References: