Persistent Atrial FibrillationWATCH-RhythmNCT03835338
WATCHMAN for Concomitant Left Atrial Appendage Electrical Isolation and Occlusion to Treat Persistent Atrial Fibrillation Rhythm
A study testing Pulmonary Vein Isolation, LAA Isolation and LAA Occlusion in people with Persistent Atrial Fibrillation, run by Boston Scientific Corporation.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Pulmonary Vein Isolation, LAA Isolation and LAA Occlusion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
About this study
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.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Pulmonary Vein Isolation, LAA Isolation, LAA Occlusion
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Vein IsolationDevice
Pulmonary Vein Isolation by RF Ablation
LAA IsolationDevice
LAA Isolation by RF Ablation
LAA OcclusionDevice
LAA Occlusion by implantation of the WATCHMAN LAAC Device
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | The test group will receive Pulmonary Vein Isolation, LAA Isolation and LAA Occlusion with the WATCHMAN LAAC Device Receives: Device: Pulmonary Vein Isolation; Device: LAA Isolation; Device: LAA Occlusion |
| Control Group | Active comparator | The control group will receive Pulmonary Vein Isolation Receives: Device: Pulmonary Vein Isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start1 Sep 2021 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2024 (estimated)
Why it stopped: Sponsor discretion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment Arm - PVI, LAA Isolation and WATCHMAN LAAC Implantation Control Arm - PVI
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835338
- Sponsor's protocol ID
- S2236
- Acronym
- WATCH-Rhythm
- Status last verified
- Mar 2022
- First submitted
- 7 Feb 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WATCHMAN for Concomitant Left Atrial Appendage Electrical Isolation and Occlusion to Treat Persistent Atrial Fibrillation Rhythm
- ClinicalTrials.gov ID
- NCT03835338
- Acronym / sponsor ID
- WATCH-Rhythm / S2236
- Conditions
- Persistent Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor discretion
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 8 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Treatment Arm - PVI, LAA Isolation and WATCHMAN LAAC Implantation Control Arm - PVI
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Device: Pulmonary Vein Isolation, Device: LAA Isolation, Device: LAA OcclusionThe test group will receive Pulmonary Vein Isolation, LAA Isolation and LAA Occlusion with the WATCHMAN LAAC Device |
| Control Group | Active comparator | Device: Pulmonary Vein IsolationThe control group will receive Pulmonary Vein Isolation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary Vein IsolationPulmonary Vein Isolation by RF Ablation | Device | Control Group, Test Group |
| LAA IsolationLAA Isolation by RF Ablation | Device | Test Group |
| LAA OcclusionLAA Occlusion by implantation of the WATCHMAN LAAC Device | Device | Test Group |
Primary outcome
Freedom from AF
Time frame: 12 months
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Vein Isolation, LAA Isolation and LAA Occlusion in people with Persistent Atrial Fibrillation, run by Boston Scientific Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from AF (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.