HW006 LATERAL Thoracotomy (HVAD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02268942|
Recruitment Status : Completed
First Posted : October 20, 2014
Results First Posted : November 12, 2019
Last Update Posted : December 2, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Left Sided Heart Failure||Device: HeartWare HVAD Procedure: Thoracotomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||144 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2018|
Experimental: HeartWare HVAD via Thoracotomy
HeartWare HVAD implanted via thoracotomy
Device: HeartWare HVAD
Implant of HeartWare HVAD via thoracotomy implant technique
Thoracotomy implant technique
- Subject is Alive on Original Device, Transplanted, or Explanted for Recovery at 6 Months [ Time Frame: 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).
- Mean Length of Initial Hospital Stay [ Time Frame: Initial Hospital Stay ]Mean length of initial hospital stay including both acute care (ICU/CCU) and step-down Care time
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02268942