Clinical trial NCT02268942: HW006 LATERAL Thoracotomy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Left Sided Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: INTERMACS
First posted: 2014-10-20
Enrollment: 144
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Subject is Alive on Original Device, Transplanted, or Explanted for Recovery at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Mean Length of Initial Hospital Stay
timeFrame: Initial Hospital Stay
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama
state: Alabama
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
city: San Diego
country: United States
facility: UC San Diego
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Tampa
country: United States
facility: Tampa Transplant Institute/Tampa General Hospital
state: Florida
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: IU Health Methodist
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Hospital
state: Indiana
city: Louisville
country: United States
facility: Jewish Hospital - Rudd Heart and Lung Institute
state: Kentucky
city: New Orleans
country: United States
facility: John Ochsner Heart & Vascular Institute
state: Louisiana
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: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Rochester
country: United States
facility: Mayo Rochester - St. Mary's Hospital
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's Hospital of Kansas City
state: Missouri
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
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: Allegheny General Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
References:
citation: 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 device: The LATERAL clinical trial. J Heart Lung Transplant. 2019 Apr;38(4):344-351. doi: 10.1016/j.healun.2019.02.002.
citation: Wieselthaler GM, Klein L, Cheung AW, Danter MR, Strueber M, Mahr C, Mokadam NA, Maltais S, McGee EC Jr. Two-Year Follow Up of the LATERAL Clinical Trial: A Focus on Adverse Events. Circ Heart Fail. 2021 Apr;14(4):e006912. doi: 10.1161/CIRCHEARTFAILURE.120.006912. Epub 2021 Apr 19.
citation: Mahr C, McGee E Jr, Cheung A, Mokadam NA, Strueber M, Slaughter MS, Danter MR, Levy WC, Cheng RK, Beckman JA, May DM, Ismyrloglou E, Tsintzos SI, Silvestry SC. Cost-Effectiveness of Thoracotomy Approach for the Implantation of a Centrifugal Left Ventricular Assist Device. ASAIO J. 2020 Aug;66(8):855-861. doi: 10.1097/MAT.0000000000001209.