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Transcatheter Heart Valve

WATCHMAN for Atrial Fibrillation

N/A
Waitlist Available
Led By Samir Kapadia, MD
Research Sponsored by samir kapadia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 1 year post-randomization
Awards & highlights

Study Summary

This trial is testing whether a left atrial appendage occlusion with WATCHMAN Device is safe and effective in preventing stroke and bleeding in patients with atrial fibrillation who are undergoing transcatheter aortic valve replacement.

Eligible Conditions
  • Atrial Fibrillation
  • Aortic Valve Stenosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 1 year post-randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 1 year post-randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite of all-cause mortality, stroke and bleeding
Secondary outcome measures
All-cause mortality
Bleeding
Stroke
Other outcome measures
Cardiovascular mortality
Procedural costs
Quality of Life Score: KCCQ-12
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TAVR + WATCHMANExperimental Treatment2 Interventions
n=175 will undergo simultaneous Transcatheter Aortic Valve Replacement (TAVR) with a WATCHMAN device.
Group II: TAVR + Medical TherapyActive Control1 Intervention
n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
WATCHMAN
2017
N/A
~670
TAVR
2017
N/A
~5790

Find a Location

Who is running the clinical trial?

samir kapadiaLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
Boston Scientific CorporationIndustry Sponsor
719 Previous Clinical Trials
932,721 Total Patients Enrolled
69 Trials studying Atrial Fibrillation
28,061 Patients Enrolled for Atrial Fibrillation
The Cleveland ClinicOTHER
1,027 Previous Clinical Trials
1,363,929 Total Patients Enrolled
22 Trials studying Atrial Fibrillation
5,362 Patients Enrolled for Atrial Fibrillation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
WATCH-TAVR, WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement
samir kapadia 2017. "WATCH-TAVR, WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03173534.
~48 spots leftby Apr 2025
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