The REFLECT Trial: Cerebral Protection to Reduce Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation
Completed · Not applicable
Conditions studied: Symptomatic Aortic Stenosis
In brief
The Keystone Heart TriGuard™ HDH is an aortic embolism deflection device intended to reduce the amount of embolic material that may enter the carotid, subclavian, and vertebral arteries during transcatheter heart valve implantation. The objective of the study is to assess the safety and efficacy of the TriGuard™ HDH embolic deflection device in patients undergoing transcatheter aortic valve implantation (TAVI), in comparison with an active control group of patients undergoing unprotected TAVI. Subjects with indications for TAVI and who meet study eligibility criteria will be randomized 2:1 to one of two treatment arms: 1) Intervention: Embolic protection device (TriGuard™) with transcatheter aortic valve implantation or 2) Control: Unprotected transcatheter aortic valve implantation.
Key facts
- Study ID
- NCT02536196
- Run by
- Keystone Heart
- People needed
- 478
- Starts
- 2016-06-01
- Expected to finish
- 2019-06-01
- Last updated by the study team
- 2021-02-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- Foundation for Cardiovascular Medicine — San Diego, California, United States
- Yale New Haven Hospital — New Haven, Connecticut, United States
- MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
- Morton Plant Hospital — Clearwater, Florida, United States
- Delray Medical Center — Hialeah, Florida, United States
- Piedmont Hospital — Atlanta, Georgia, United States
- Northwestern University — Evanston, Illinois, United States
- University of Iowa — Iowa City, Iowa, United States
- Cardiovascular Institute of the South — Houma, Louisiana, United States
- Morristown Medical Center — Morristown, New Jersey, United States
- New York University — New York, New York, United States
- Columbia University Medical Center/NYPH — New York, New York, United States
- St. Francis Hospital — Roslyn, New York, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- Pinnacle Health — Harrisburg, Pennsylvania, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Baylor Heart and Vascular HospitalBaylor Heart and Vascular — Dallas, Texas, United States
- Houston Methodist Hospital — Houston, Texas, United States
- University of Texas — Houston, Texas, United States
- Baylor Research Center — Plano, Texas, United States
- University of Virginia — Charlottesville, Virginia, United States
- Swedish Medical Center — Seattle, Washington, United States
- University of Bonn — Bonn, Germany
- Universitats-Herzzentrum Freiburg — Freiburg im Breisgau, Germany
Full record on ClinicalTrials.gov
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