Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04149535 · ClinicalTrials.gov registry record · NA
PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement
A NA study, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- NA
- Development phase
- 3,000
- Enrollment target
NCT04149535: Completed NA study, sponsored by Boston Scientific Corporation.
NCT04149535 is a NA study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 3,000 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (114% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04149535, a NA study, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 3,000 participants
- Enrollment target
Study Summary
To demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR).
Primary Outcome
All stroke (hemorrhagic, ischemic, or undetermined status; disabling or nondisabling) through 72 hours post TAVR procedure or discharge (whichever comes first), as adjudicated by an independent Clinical Events Committee (CEC) and using Neurologic Academic Research Consortium (NeuroARC) definitions.
Interventions
- DEVICE Sentinel® Cerebral Protection System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,000 participants |
| Start Date | 2020-02-07 |
| Est. Completion | 2022-02-01 |
| Phase | NA |
What the finished NCT04149535 record still lists
NCT04149535 is an interventional study that assigns participants to a tested intervention. Its 3,000 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (114% higher).
The record links to 0 conditions, and to 1 intervention - of which Sentinel® Cerebral Protection System is the first listed.
NCT04149535 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04149535 about?
NCT04149535 is a clinical study titled "PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement". To demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR).
What is the current status of trial NCT04149535?
This trial is currently completed. It is a NA study. The enrollment target is 3,000 participants. The study started on 2020-02-07. Estimated completion is 2022-02-01.
What interventions are being tested in trial NCT04149535?
The interventions under investigation include: Sentinel® Cerebral Protection System (DEVICE).
Who is sponsoring clinical trial NCT04149535?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04149535's enrollment target sits among peer trials
3,000 40th of 2000 higher than 1,959 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00004847 · 3,000 participants · Phase 1
Diagnosis of Pheochromocytoma
- NCT00478712 · 3,000 participants
Hirschsprung Disease Genetic Study
- NCT00579566 · 3,000 participants
Novel Biochemical and Molecular Determinants for Soft Tissue Sarcoma
- NCT00816114 · 3,000 participants
Chart Review Study of Chronic Myelogenous Leukemia (CML) Patients Treated With Imatinib Outside of a Clinical Trial
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI