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

Completed

• Conditions: Left Ventricular Assist Device; Anticoagulation

• Registration Number: NCT01477528
• Lead Sponsor: Abbott Medical Devices

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-17
• Study First Submitted QC: 2011-11-21
• Study First Posted: 2011-11-22
• Primary Completion: 2015-07
• Study Completion: 2015-08
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-23
• Last Update Posted: 2022-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

• 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.

OR

-- 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of thromboembolic events and hemorrhagic events	24 months

Trial Locations

Locations (18)

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Sharp Memorial Hospital; 🇺🇸 San Diego, California, United States

Chirurgie Thoracique et Cardiovasculaire Groupe hospitalier Pitie-Salpetriere; 🇫🇷 Paris, France

Hopital Cardiologique; 🇫🇷 Lille, France

IKEM; 🇨🇿 Prague, Czechia

Medical University Hannover; 🇩🇪 Hannover, Germany

Service de Chirurgie Cardiaque; 🇫🇷 Grenoble, France

Hôpital Pontchaillou; 🇫🇷 Rennes, France

Charles Nicolle University Hospital; 🇫🇷 Rouen, France

University of Freiburg Medical Center; 🇩🇪 Freiburg, Germany

Methodist Hospital of Indiana; 🇺🇸 Indianapolis, Indiana, United States

St. Vincent Heart Center of Indiana; 🇺🇸 Indianapolis, Indiana, United States

University of Florida (Shands); 🇺🇸 Gainesville, Florida, United States

Advocate Christ Hospital; 🇺🇸 Oak Lawn, Illinois, United States

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Medical University of Vienna; 🇦🇹 Vienna, Austria

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States