- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03835338
WATCHMAN for Concomitant Left Atrial Appendage Electrical Isolation and Occlusion to Treat Persistent Atrial Fibrillation Rhythm (WATCH-Rhythm)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test Group
The test group will receive Pulmonary Vein Isolation, LAA Isolation and LAA Occlusion with the WATCHMAN LAAC Device
|
Pulmonary Vein Isolation by RF Ablation
LAA Isolation by RF Ablation
LAA Occlusion by implantation of the WATCHMAN LAAC Device
|
Active Comparator: Control Group
The control group will receive Pulmonary Vein Isolation
|
Pulmonary Vein Isolation by RF Ablation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Freedom from AF
Time Frame: 12 months
|
Not having any of the following after the blanking period:
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S2236
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Persistent Atrial Fibrillation
-
Ablacon, Inc.CompletedArrhythmias, Cardiac | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationGermany
-
AtriCure, Inc.Active, not recruitingPersistent Atrial Fibrillation | Atrial Fibrillation (AF) | Longstanding Persistent Atrial FibrillationUnited States
-
University of LuebeckIHF GmbH - Institut für HerzinfarktforschungRecruitingPersistent or Long-standing Persistent Atrial FibrillationGermany
-
St. George's Hospital, LondonRecruitingAtrial Fibrillation | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial ArrhythmiaUnited Kingdom
-
Barts & The London NHS TrustAtriCure, Inc.Not yet recruitingAtrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial Arrhythmia | Atrium; FibrillationUnited Kingdom
-
Xinhua Hospital, Shanghai Jiao Tong University...RecruitingPersistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationChina
-
University Medical Centre LjubljanaWithdrawnPersistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationSlovenia
-
AtriCure, Inc.CompletedPersistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationUnited States
-
Medtronic Bakken Research CenterTerminatedLongstanding Persistent Atrial FibrillationSpain, Germany, Israel, Italy
-
Medtronic Cardiac SurgeryRecruitingPersistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationUnited States
Clinical Trials on Pulmonary Vein Isolation
-
University of LeipzigRecruiting
-
University Medical Center GroningenBoston Scientific CorporationNot yet recruiting
-
Instituto de investigación e innovación biomédica...Active, not recruitingAtrial Fibrillation, PersistentSpain
-
Brigham and Women's HospitalBoston Scientific CorporationNot yet recruitingAtrial Fibrillation ParoxysmalUnited States
-
Hospital General Universitario de AlicanteNot yet recruiting
-
AtriCure, Inc.Active, not recruitingAtrial FibrillationUnited States
-
Asklepios proresearchCompletedAtrial Fibrillation | TachycardiaGermany
-
Diagram B.V.CompletedParoxysmal Atrial Fibrillation | Persistent Atrial Fibrillation | Out of Range Hypertension | Signs of Sympathetic OverdriveSpain, Netherlands
-
Haukeland University HospitalUniversity Hospital of North Norway; St. Olavs HospitalCompletedPersistent Atrial FibrillationNorway
-
Hospital Clinic of BarcelonaRecruiting