TCEP in VIV TAVR for Aortic Valve Disease
Trial Summary
What is the purpose of this trial?
The objective of this study is to quantify the amount of debris captured by the SENTINEL transcatheter cerebral embolic protection (TCEP) device in patients undergoing valve in valve transcatheter aortic valve replacement (VIV TAVR) with bioprosthetic valvular fracture (BVF)
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What data supports the effectiveness of the treatment SENTINEL transcatheter cerebral embolic protection (TCEP) device?
Is the Sentinel cerebral embolic protection device safe for use in humans?
How is the Sentinel Cerebral Protection System treatment different from other treatments for aortic valve disease?
Research Team
Adnan Chhatriwalla, MD
Principal Investigator
Saint Luke's Health System
Eligibility Criteria
This trial is for adults over 18 with severe degeneration of a previously placed artificial aortic valve who need a new non-surgical valve replacement. Candidates must have suitable blood vessel anatomy, be able to give informed consent, and commit to follow-up visits. They should not have had recent strokes, significant artery narrowing, certain heart conditions or be pregnant.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo VIV TAVR with BVF using the SENTINEL TCEP device
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- SENTINEL transcatheter cerebral embolic protection (TCEP) device
SENTINEL transcatheter cerebral embolic protection (TCEP) device is already approved in United States, European Union for the following indications:
- Transcatheter aortic valve replacement (TAVR) procedures to capture and remove thrombus/debris
- Transcatheter aortic valve replacement (TAVR) procedures to capture and remove thrombus/debris
Find a Clinic Near You
Who Is Running the Clinical Trial?
Saint Luke's Health System
Lead Sponsor
Boston Scientific Corporation
Industry Sponsor
Michael F. Mahoney
Boston Scientific Corporation
Chief Executive Officer since 2016
MBA from Wake Forest University, BBA in Finance from the University of Iowa
Kenneth Stein
Boston Scientific Corporation
Chief Medical Officer since 2020
MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology