Study of Reduced Anti-coagulation/Anti-platelet Therapy in Patients With the HeartMate II Left Ventricular Assist System (LVAS) (TRACE)

NCT01477528 | Completed

• 1 other identifier: TC-081611
• Study Type: observational
• Target: 201
• Locations: 5 countries
• Sites: 18

Brief Summary

The purpose of this observational study is to obtain multi-center data on HeartMate II (HMII) patients managed with reduced anticoagulation or anti-platelet regimes, and the incidence of thrombotic and bleeding adverse events associated with these regimes.

Conditions

Anticoagulation; Left Ventricular Assist Device

Keywords

HeartMate II; Anticoagulation; Thoratec Corporation

Outcome Measures

Primary Outcomes (1)

• Rate of thromboembolic events and hemorrhagic events

  24 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with HeartMate II VAD that are on reduced anticoagulation/antiplatelet regimine

You may qualify if:

• HeartMate II Left Ventricular Assist Device (LVAD) patient
• Patient has signed an informed consent for data collection.
• Patient was discharged, or is being discharged, from the hospital after their initial LVAD implant surgery.
• Patient:
• at time of enrolling in study, is currently on, with the intention of being maintained on reduced anti-thrombotic therapy (RT) for chronic long-term management.
• \-- On or after January 1, 2011 patient was being maintained on, or had been initiated with the intention of being maintained on, reduced anti-thrombotic therapy (RT) for chronic long-term management; but where RT was subsequently discontinued due to an adverse event or transplant, explant, or death.

You may not qualify if:

• Patients under acute management of anti-thrombotic agents before a final decision on long term antithrombotic strategy.
• Patients requiring a legal representative to sign consent form, rather than themselves.
• Patient is being managed on other anti-thrombotic agents

Sponsors & Collaborators

• Abbott Medical Devices: lead
• Thoratec Europe Ltd: collaborator

Study Sites (18)

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

University of Florida (Shands)

Gainesville, Florida, 32610, United States

Location

Advocate Christ Hospital

Oak Lawn, Illinois, 60453, United States

Location

Methodist Hospital of Indiana

Indianapolis, Indiana, 46202, United States

Location

St. Vincent Heart Center of Indiana

Indianapolis, Indiana, 46260, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Medical University of Vienna

Vienna, Austria

Location

IKEM

Prague, Czechia

Location

Service de Chirurgie Cardiaque

Grenoble, France

Location

Hopital Cardiologique

Lille, France

Location

Chirurgie Thoracique et Cardiovasculaire Groupe hospitalier Pitie-Salpetriere

Paris, France

Location

Hôpital Pontchaillou

Rennes, France

Location

Charles Nicolle University Hospital

Rouen, France

Location

University of Freiburg Medical Center

Freiburg im Breisgau, Germany

Location

Medical University Hannover

Hanover, Germany

Location

Study Officials

• Pooja Chatterjee

  Thoratec Europe Limited

  STUDY DIRECTOR

• David Farrar, PhD

  Thoratec Corporation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: November 22, 2011
• Study Start: November 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: June 24, 2022

Record last verified: 2022-06

Locations

US (9); CZ (1); FR (5); AU (1); DE (2)