HW006 LATERAL Thoracotomy

Left Sided Heart Failure Clinical Trial

— HVAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02268942
• Other study ID #: HW006 Thoracotomy
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: October 2018

Study information

• Verified date: November 2019
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: October 2018
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Must be =19 years of age at time of informed consent to participate in the Intermacs® registry.

2. Subject receives a HeartWare HVAD (The device should be the subject's first VAD implant).

3. Subject signed an Intermacs® informed consent if required by local IRB policy.

4. Subject signed a HeartWare informed consent.

Exclusion Criteria:

1. Subject is incarcerated (prisoner).

2. Subject did not sign the informed consent at sites where waiver of consent was not granted.

3. Body Surface Area (BSA) < 1.2 m^2.

4. Prior cardiac transplant or cardiomyoplasty.

5. Subject is receiving a BiVAD.

6. Subject is receiving the device as an RVAD.

7. Subject data is generated from non- Intermacs® centers.

8. Pediatric subjects (< 19 years of age).

9. Subjects who receive a temporary LVAD

10. Subjects whose device strategy is listed as "Destination Therapy" at the time of implant.

11. Severe Right Heart failure

12. Aortic insufficiency or mechanical aortic valve.

13. Planned concomitant procedure (e.g.valve repair or replacement, CABG, septal defect repair).

14. Known LV Thrombus.

Related Conditions & MeSH terms

• Heart Failure
• Left Sided Heart Failure

Intervention

Device:
• HeartWare HVAD
Implant of HeartWare HVAD via thoracotomy implant technique

Procedure:
• Thoracotomy
Thoracotomy implant technique

Locations

Country	Name	City	State
Canada	St. Paul's Hospital	Vancouver	British Columbia
United States	University of Michigan Hospital	Ann Arbor	Michigan
United States	The University of Alabama	Birmingham	Alabama
United States	Tufts Medical Center	Boston	Massachusetts
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Duke University Medical Center	Durham	North Carolina
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Spectrum Health	Grand Rapids	Michigan
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	IU Health Methodist	Indianapolis	Indiana
United States	St. Vincent Hospital	Indianapolis	Indiana
United States	St. Luke's Hospital of Kansas City	Kansas City	Missouri
United States	Jewish Hospital - Rudd Heart and Lung Institute	Louisville	Kentucky
United States	Loyola University Medical Center	Maywood	Illinois
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	John Ochsner Heart & Vascular Institute	New Orleans	Louisiana
United States	Stanford University School of Medicine	Palo Alto	California
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Rochester - St. Mary's Hospital	Rochester	Minnesota
United States	UC San Diego	San Diego	California
United States	UCSF Medical Center	San Francisco	California
United States	University of Washington Medical Center	Seattle	Washington
United States	Tampa Transplant Institute/Tampa General Hospital	Tampa	Florida
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure	INTERMACS

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

McGee E Jr, Danter M, Strueber M, Mahr C, Mokadam NA, Wieselthaler G, Klein L, Lee S, Boeve T, Maltais S, Pretorius GV, Adler E, Vassiliades T, Cheung A. Evaluation of a lateral thoracotomy implant approach for a centrifugal-flow left ventricular assist d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject is Alive on Original Device, Transplanted, or Explanted for Recovery at 6 Months	Alive on the originally implanted device at six months, and the subject has not had a stroke with a modified Rankin Scale = 4 (assessed = three months post-stroke event); or; Transplanted by Month 6, and the subject has not had a stroke with a modified Rankin Scale; = 4 (assessed = three months post-stroke event); or; Explanted for recovery by Month 6, and the subject has not had a stroke with a modified Rankin Scale = 4 (assessed = three months post-stroke event).	6 months
Secondary	Mean Length of Initial Hospital Stay	Mean length of initial hospital stay including both acute care (ICU/CCU) and step-down Care time	Initial Hospital Stay