WATCHMAN for Concomitant Left Atrial Appendage Electrical Isolation and Occlusion to Treat Persistent Atrial Fibrillation Rhythm

NCT03835338 | Withdrawn DMC FDA Device

• 1 other identifier: S2236
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 single procedure.

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Freedom from AF

  Not having any of the following after the blanking period: * a documented symptomatic AF event (episode of 30 sec duration or longer by Holter, event monitor or rhythm strip; or for the full 10 second recording of a standard 12 lead ECG) * treatment with a Class I or Class III AAD * a documented symptomatic AF event (episode of 30 sec duration or longer by Holter, event monitor or rhythm strip; or for the full 10 second recording of a standard 12 lead ECG) * treatment with a Class I or Class III AAD

  12 months

Study Arms (2)

Test Group

EXPERIMENTAL

The test group will receive Pulmonary Vein Isolation, LAA Isolation and LAA Occlusion with the WATCHMAN LAAC Device

Device: Pulmonary Vein Isolation; Device: LAA Isolation; Device: LAA Occlusion

Control Group

ACTIVE COMPARATOR

The control group will receive Pulmonary Vein Isolation

Device: Pulmonary Vein Isolation

Interventions

Pulmonary Vein Isolation DEVICE

Pulmonary Vein Isolation by RF Ablation

Control Group; Test Group

LAA Isolation DEVICE

LAA Isolation by RF Ablation

Test Group

LAA Occlusion DEVICE

LAA Occlusion by implantation of the WATCHMAN LAAC Device

Test Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• \. 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).
• \. The subject had a prior stroke (of any cause) or TIA within the 30 days prior to randomization.
• \. 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.
• \. 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.
• \. 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).
• \. 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.
• \. The subject has a documented life expectancy of less than two years. 17. The subject has a known or suspected hypercoagulable state

Sponsors & Collaborators

• Boston Scientific Corporation: lead

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Left Atrial Appendage Closure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Catheterization; Catheterization; Therapeutics; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Treatment Arm - PVI, LAA Isolation and WATCHMAN LAAC Implantation Control Arm - PVI

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 8, 2019
• Study Start: September 1, 2021
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2024
• Last Updated: March 31, 2022

Record last verified: 2022-03