Status:
WITHDRAWN
WATCHMAN for Concomitant Left Atrial Appendage Electrical Isolation and Occlusion to Treat Persistent Atrial Fibrillation Rhythm
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Persistent Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
WATCH-Rhythm is a prospective, randomized, multi-center, investigation to collect safety and effectiveness data on combining conventional AF ablation with LAA electric isolation and closure within a s...
Detailed Description
WATCH-Rhythm is a prospective, randomized, multi-center, investigation to collect safety and effectiveness data on combining conventional AF ablation with LAA electric isolation and occlusion within a...
Eligibility Criteria
Inclusion
- The subject is of legal age to participate in the study per the laws of their respective geography.
- The subject has documented non-valvular persistent AF. For this protocol, the definition of persistent AF is sustained arrhythmia lasting at least 7-days but less than 36 months.
- The subject is able to tolerate OAC post ablation.
- Subject is able to undergo TEE.
- The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial
- The subject is willing and capable of attending all follow-up visits at the investigational site as medically appropriate.
Exclusion
- The subject is unable or unwilling to return for required follow-up visits and examinations.
- The subject had or is planning to have any invasive cardiac procedure within 30 days prior to randomization (e.g., cardioversion, ablation).
- Previous AF ablation (surgical or percutaneous).
- Prior MAZE procedure.
- 4\. The subject is planning to have any cardiac or non-cardiac invasive or surgical procedure that would necessitate stopping or modifying the protocol required medication regimen within 90 days after the WATCHMAN Closure Device implant (e.g., cardioversion, ablation, cataract surgery).
- 5\. The subject had a prior BARC type 3 or 4 bleeding event within the 14 days prior to randomization. Lack of resolution of related clinical sequelae, or planned and pending interventions to resolve bleeding/bleeding source, are a further exclusion regardless of timing of the bleeding event.
- 6\. The subject had a prior stroke (of any cause) or TIA within the 30 days prior to randomization.
- 7\. The subject had a prior BARC type 3 or 4 bleeding event within the 14 days prior to randomization. Lack of resolution of related clinical sequelae, or planned and pending interventions to resolve bleeding/bleeding source, or a further exclusion regardless of timing of the bleeding event.
- 8\. The subject has a history of atrial septal repair or has an ASD/PFO device. 9. The subject has an implanted mechanical valve prosthesis in any position. 10. The subject suffers from New York Heart Association Class IV Congestive Heart Failure.
- 11\. Subject has LVEF \<30% 12. Subject has hypertrophic cardiomyopathy. 13. The subject has had a myocardial infarction (MI) documented in the clinical record as either a non-ST elevation MI (NSTEMI) or as an ST elevation MI (STEMI), with or without intervention, within 90 days prior to randomization.
- 14\. The subject is of childbearing potential and is, or plans to become pregnant during the time of the study (method of assessment upon study physician's discretion).
- 15\. The subject is currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.
- 16\. The subject has a documented life expectancy of less than two years. 17. The subject has a known or suspected hypercoagulable state
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03835338
Start Date
September 1 2021
End Date
April 30 2024
Last Update
March 31 2022
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