HW006 LATERAL Thoracotomy



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:19 - Any
Updated:6/1/2018
Start Date:November 2014
End Date:April 2021

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

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.


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.
We found this trial at
26
sites
800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Michael Kiernan, MD
Phone: 617-636-4990
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Principal Investigator: Anthony Rongione, MD
Phone: 703-776-2995
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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Falls Church, VA
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Matthew Danter, MD
Phone: 908-656-2799
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Pavan Atluri, MD
Phone: 215-662-4806
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Philadelphia, PA
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Ann Arbor, Michigan 48109
Principal Investigator: Jonathan Haft, MD
Phone: 734-764-0599
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Ann Arbor, MI
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Birmingham, Alabama 35294
Principal Investigator: William Holman, MD
Phone: 205-996-9975
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Birmingham, AL
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Principal Investigator: Duc Thinh Pham, MD
Phone: 312-926-9874
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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Chicago, IL
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Carmelo Milano, MD
Phone: 919-681-1779
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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Grand Rapids, Michigan 49503
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Grand Rapids, MI
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Hershey, Pennsylvania 17033
Principal Investigator: Stephenson Edward, MD
Phone: 717-531-5967
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Hershey, PA
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Indianapolis, Indiana 46202
Principal Investigator: Zubair Hashmi, MD
Phone: 317-962-9904
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Indianapolis, IN
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Indianapolis, Indiana
Principal Investigator: Chris Salerno, MD
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Kansas City, Missouri 64111
Principal Investigator: Sanjeev Aggarwal, MD
Phone: 816-932-1627
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Louisville, Kentucky 40202
Principal Investigator: Mark Slaughter, MD
Phone: 502-587-4630
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Louisville, KY
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Principal Investigator: Edwin McGee, MD
Phone: 708-327-2494
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Maywood, IL
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New Orleans, Louisiana 70115
Principal Investigator: Aditya Bansal, MD
Phone: 504-842-5257
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New Orleans, LA
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Palo Alto, California 94304
Principal Investigator: Joseph Woo, MD
Phone: 650-498-1232
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Palo Alto, CA
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Principal Investigator: Stephen Bailey, MD
Phone: 412-359-6181
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Pittsburgh, PA
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Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: Daniel Tang, MD
Phone: 804-628-2520
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Richmond, VA
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Rochester, Minnesota 55905
Principal Investigator: David Joyce, MD
Phone: 507-255-8605
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Rochester, MN
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San Diego, California 92093
Principal Investigator: Gert Pretorius, MD
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San Diego, CA
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San Francisco, California 94115
Principal Investigator: Georg Wieselthaler, MD
Phone: 415-514-6017
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
Principal Investigator: Nahush Mokadam, MD
Phone: 206-499-1343
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Seattle, WA
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Tampa, Florida 33606
Principal Investigator: Christiano Caldeira, MD
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Tampa, FL
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Vancouver, British Columbia
Principal Investigator: Anson Cheung, MD
Phone: 604-806-8976
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110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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Washington,
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