The REFLECT Trial: Cerebral Protection to Reduce Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation
Public ClinicalTrials.gov record NCT02536196. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Evaluation of the TriGuard Embolic Deflection Device to Reduce the Impact of Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02536196
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 478 participants
Conditions and interventions
Conditions
Interventions
- Embolic Protection Device Device
- Transcatheter aortic valve implantation (TAVI) Procedure
Device · Procedure
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2016
- Primary completion
- Apr 30, 2019
- Completion
- May 31, 2019
- Last update posted
- Feb 17, 2021
2016 – 2019
United States locations
- U.S. sites
- 23
- U.S. states
- 15
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Foundation for Cardiovascular Medicine | San Diego | California | 92122 | — |
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | — |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Morton Plant Hospital | Clearwater | Florida | 33756 | — |
| Delray Medical Center | Hialeah | Florida | 33016 | — |
| Piedmont Hospital | Atlanta | Georgia | 30309 | — |
| Northwestern University | Evanston | Illinois | 60208 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Cardiovascular Institute of the South | Houma | Louisiana | 70360 | — |
| Morristown Medical Center | Morristown | New Jersey | 07960 | — |
| New York University | New York | New York | 10016 | — |
| Columbia University Medical Center/NYPH | New York | New York | 10032 | — |
| St. Francis Hospital | Roslyn | New York | 11576 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Pinnacle Health | Harrisburg | Pennsylvania | 17101 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Baylor Heart and Vascular HospitalBaylor Heart and Vascular | Dallas | Texas | 75201 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| University of Texas | Houston | Texas | 77030 | — |
| Baylor Research Center | Plano | Texas | 75093 | — |
| University of Virginia | Charlottesville | Virginia | 22903 | — |
| Swedish Medical Center | Seattle | Washington | 98122 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02536196, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 17, 2021 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02536196 live on ClinicalTrials.gov.