WATCH-TAVR, WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement

NCT ID: NCT03173534

Last Updated: 2024-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-15
• Study Completion Date: 2022-12-06

Brief Summary

To evaluate the safety and effectiveness of the left atrial appendage occlusion with WATCHMAN Device in prevention of stroke and bleeding in patients with atrial fibrillation (AF) undergoing transcatheter aortic valve replacement (TAVR).

Detailed Description

WATCH-TAVR is a prospective, multicenter, randomized controlled trial. Only centers with approval for commercial WATCHMAN implantation will be included in this trial. Subjects will be enrolled at up to 32 centers in the United States. There will be up to 350 subjects enrolled, with 175 patients randomized to TAVR + medical therapy and 175 patients randomized to simultaneous TAVR+WATCHMAN to accumulate the necessary 191 primary events. Enrollment is expected to occur over the course of 18 months. Patients will be followed for a total of 2 years. Patients with non-valvular AF undergoing standard of care commercial TAVR will be enrolled in the trial.

For patients who receive the WATCHMAN device, plan of care will follow WATCHMAN labeling.Patients randomized to receive the WATCHMAN device will receive anticoagulation with warfarin and aspirin for 6 weeks after the procedure. After 6 weeks, the plan of care will follow WATCHMAN labeling. Patients randomized to the TAVR + medical therapy arm will be treated in accordance with standard of care with either warfarin, other anticoagulant/antiplatelet therapy, or no anticoagulation at the discretion of the treating physician. All patients will continue to receive routine post-TAVR follow-up and care.Patients will be monitored for primary and secondary endpoints as outlined. Baseline information and laboratory data will be collected as described in the protocol.

At trial conclusion, total number of subjects enrolled was 349. There were 172 subjects enrolled in the TAVR + Medical Therapy arm and 177 subjects enrolled in the TAVR + WATCHMAN arm.

Conditions

Atrial Fibrillation; Aortic Valve Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

TAVR + Medical Therapy

n=172 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation

Group Type: ACTIVE_COMPARATOR

TAVR

Intervention Type: DEVICE

Transcatheter Aortic Valve Replacement

TAVR + WATCHMAN

n=177 will undergo simultaneous Transcatheter Aortic Valve Replacement (TAVR) with a WATCHMAN device.

Group Type: EXPERIMENTAL

WATCHMAN

Intervention Type: DEVICE

WATCHMAN Device is composed of a self-expanding nitinol structure with a porous membrane on the proximal face. The implant device is delivered to the Left Atrial Appendage by femoral venous access and transseptal puncture to enter the left atrium.

TAVR

Intervention Type: DEVICE

Transcatheter Aortic Valve Replacement

Interventions

WATCHMAN

WATCHMAN Device is composed of a self-expanding nitinol structure with a porous membrane on the proximal face. The implant device is delivered to the Left Atrial Appendage by femoral venous access and transseptal puncture to enter the left atrium.

Intervention Type: DEVICE

TAVR

Transcatheter Aortic Valve Replacement

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Men and women ≥ 18 years of age.

2. The patient meets criteria for and is scheduled to undergo TAVR procedure

3. The patient has documented paroxysmal, persistent, or permanent atrial fibrillation.

4. The patient meets the WATCHMAN labeling guidelines and is eligible to undergo the WATCHMAN implantation procedure.

5. The patient is eligible for short term warfarin therapy.

6. The patient or legal representative is able to understand and willing to provide written informed consent to participate in the trial.

7. The patient is able and willing to return for required follow-up visits and examinations.

Exclusion Criteria

1. The patient had a stroke or TIA within the last 6 months prior to enrollment.

2. Contraindication for short term anticoagulation.

3 .Moderate or severe Mitral Stenosis with mean gradient across Mitral Valve >10 mm Hg or Mitral Valve Area < 1.2cm2.

4. The patient has symptomatic carotid disease (i.e.,carotid stenosis ≥ 50% associated with ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke within 6 months).

5. Prior occlusion of LAA.

6. The patient has an implanted mechanical mitral valve.

7. The patient requires long-term warfarin therapy due to:

1. Secondary to conditions such as prior arterial embolism or other indications such as pulmonary embolism or deep vein thrombosis within the previous 6 months

2. The patient is in a hypercoaguable state; exclude the patient if per medical record documentation, the patient meets any of the following criteria:

• Thrombosis occurring ≤ 40 years of age
• Idiopathic or recurrent VTE (venous thrombo-embolism)
• Thrombosis at an unusual site (cerebral veins, hepatic veins, renal veins, IVC, mesenteric veins)
• Family history of VTE or of inherited prothrombotic disorder, recurrence/extension of thrombosis while adequately anticoagulated.

8. The patient is actively enrolled in another trial of a cardiovascular device or an investigational drug (post-market study participation and registries are acceptable).

9. The patient is pregnant or pregnancy is planned during the course of the investigation if patient is of child bearing potential.

10. Any clinically significant medical condition or presence of any laboratory abnormality prior to randomization that is considered by the investigator to be clinically important and could interfere with the conduct of the study or not meeting procedure guidelines for TAVR or WATCHMAN.

11. The patient has a life expectancy of less than two years.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

samir kapadia

OTHER

Sponsor Role: lead

Responsible Party

samir kapadia

Study Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Samir Kapadia, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Banner University Medical Center

Phoenix, Arizona, United States

Sutter Health/Palo Alto Medical Foundation

Burlingame, California, United States

Santa Barbara Cottage Hospital

Santa Barbara, California, United States

UCHealth Medical Center of the Rockies

Loveland, Colorado, United States

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States

Baptist Health Jacksonville

Jacksonville, Florida, United States

Northside Hospital

St. Petersburg, Florida, United States

Tallahassee Research Institute

Tallahassee, Florida, United States

Prairie Cardiovascular Consultants

Springfield, Illinois, United States

Parkview Research Center

Fort Wayne, Indiana, United States

St. Vincent Heart Center

Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Ascension St. John Hospital

Detroit, Michigan, United States

Medstar Washington University

St Louis, Missouri, United States

CHI Health Research Center

Omaha, Nebraska, United States

Morristown Medical Center

Morristown, New Jersey, United States

University at Buffalo

Buffalo, New York, United States

Columbia University Medical Center

New York, New York, United States

The Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

OhioHealth Research Institute

Columbus, Ohio, United States

INTEGRIS Baptist Medical Center

Oklahoma City, Oklahoma, United States

Pinnacle Health

Wormleysburg, Pennsylvania, United States

WellSpan York Hospital

York, Pennsylvania, United States

Lexington Cardiology

West Columbia, South Carolina, United States

Austin Heart

Austin, Texas, United States

Heart Hospital Baylor Plano

Plano, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Aspirus Research Institute

Wausau, Wisconsin, United States

Countries

United States

References

Kapadia SR, Krishnaswamy A, Whisenant B, Potluri S, Iyer V, Aragon J, Gideon P, Strote J, Leonardi R, Agarwal H, Larrain G, Sanchez C, Panaich SS, Harvey J, Vahl T, Menon V, Wolski K, Wang Q, Leon MB. Concomitant Left Atrial Appendage Occlusion and Transcatheter Aortic Valve Replacement Among Patients With Atrial Fibrillation. Circulation. 2024 Mar 5;149(10):734-743. doi: 10.1161/CIRCULATIONAHA.123.067312. Epub 2023 Oct 24.

Reference Type: DERIVED

PMID: 37874908 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

WATCH-TAVR

Identifier Type: -

Identifier Source: org_study_id