CClinicalTrials.gg
WithdrawnNCT03835338WATCH-RhythmUpdated Mar 31, 2022

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

An interventional study of Pulmonary Vein Isolation and LAA Isolation in Persistent Atrial Fibrillation, sponsored by Boston Scientific Corporation. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Sponsor discretion
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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 single procedure.

The primary objective is to test the effectiveness of adding LAA electrical isolation and closure to conventional atrial fibrillation versus conventional atrial fibrillation alone in treating patient with persistent atrial fibrillation from a single procedure.

This study will be conducted at up to 10 global sites in the European Union (United Kingdom, Spain, Germany, or others). The maximum enrollment ceiling for the Watch-Rhythm study is 278 subjects. Included in the enrollment ceiling are up to 20 roll-in subjects and a maximum of 258 randomized subjects.

The duration of the study is expected to last approximately 4 years. Enrollment is expected to take approximately 24 months. The duration of individual subject participation is expected to last approximately 2 years but may vary per subject.

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Conditions studied

  • Persistent Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

Browse Atrial Fibrillation studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. The subject is of legal age to participate in the study per the laws of their respective geography.
  2. 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.
  3. The subject is able to tolerate OAC post ablation.
  4. Subject is able to undergo TEE.
  5. The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial
  6. The subject is willing and capable of attending all follow-up visits at the investigational site as medically appropriate.

Exclusion criteria

Exclusion Criteria:

  1. The subject is unable or unwilling to return for required follow-up visits and examinations.
  2. The subject had or is planning to have any invasive cardiac procedure within 30 days prior to randomization (e.g., cardioversion, ablation).
  3. Previous AF ablation (surgical or percutaneous).
  4. Prior MAZE procedure.
  1. 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).
  1. 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.
  1. The subject had a prior stroke (of any cause) or TIA within the 30 days prior to randomization.
  1. 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.
  1. 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.
  1. 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.
  1. 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).
  1. 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.
  1. The subject has a documented life expectancy of less than two years. 17. The subject has a known or suspected hypercoagulable state
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Test Group

    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

  • Active comparator
    Control Group

    The control group will receive Pulmonary Vein Isolation

    Device: Pulmonary Vein Isolation

Interventions

  • DevicePulmonary Vein Isolation

    Pulmonary Vein Isolation by RF Ablation

  • DeviceLAA Isolation

    LAA Isolation by RF Ablation

  • DeviceLAA Occlusion

    LAA Occlusion by implantation of the WATCHMAN LAAC Device

06

What researchers measure

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

    Time frame: 12 months

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03835338
Lead sponsor
Boston Scientific Corporation
Responsible party
Sponsor
First posted
Feb 8, 2019
Start date
Sep 1, 2021 (estimated)
Primary completion
Apr 30, 2023 (estimated)
Completion
Apr 30, 2024 (estimated)
Last update
Mar 31, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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