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

NCT03173534 | Completed Results FDA Device

• 1 other identifier: WATCH-TAVR
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 32

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).

Conditions

Atrial Fibrillation; Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• Composite of All-cause Mortality, Stroke and Bleeding

  First occurrence of all-cause mortality, stroke (ischemic or hemorrhagic), or bleeding (life-threatening and major) events through 2 years post-randomization.

  Through 2 year post-randomization

Secondary Outcomes (3)

• All-cause Mortality

  Through 2 year post-randomization

• Stroke

  Through 2 year post-randomization

• Bleeding

  Through 2 year post-randomization

Other Outcomes (5)

• Cardiovascular Mortality

  Through 2 year post-randomization

• Thrombus or Embolism

  Through 2 year post-randomization

• Re-hospitalization

  Through 2 year post-randomization

Study Arms (2)

TAVR + Medical Therapy

ACTIVE COMPARATOR

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

Device: TAVR

TAVR + WATCHMAN

EXPERIMENTAL

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

Device: WATCHMAN; Device: TAVR

Interventions

WATCHMAN 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 + WATCHMAN

TAVR DEVICE

Transcatheter Aortic Valve Replacement

TAVR + Medical Therapy; TAVR + WATCHMAN

Eligibility Criteria

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

You may qualify if:

• Men and women ≥ 18 years of age.
• The patient meets criteria for and is scheduled to undergo TAVR procedure
• The patient has documented paroxysmal, persistent, or permanent atrial fibrillation.
• The patient meets the WATCHMAN labeling guidelines and is eligible to undergo the WATCHMAN implantation procedure.
• The patient is eligible for short term warfarin therapy.
• The patient or legal representative is able to understand and willing to provide written informed consent to participate in the trial.
• The patient is able and willing to return for required follow-up visits and examinations.

You may not qualify if:

• The patient had a stroke or TIA within the last 6 months prior to enrollment.
• Contraindication for short term anticoagulation.
• Moderate or severe Mitral Stenosis with mean gradient across Mitral Valve \>10 mm Hg or Mitral Valve Area \< 1.2cm2.
• \. 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).
• \. Prior occlusion of LAA.
• \. The patient has an implanted mechanical mitral valve.
• \. The patient requires long-term warfarin therapy due to:
• Secondary to conditions such as prior arterial embolism or other indications such as pulmonary embolism or deep vein thrombosis within the previous 6 months
• 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.
• \. The patient is actively enrolled in another trial of a cardiovascular device or an investigational drug (post-market study participation and registries are acceptable).
• \. The patient is pregnant or pregnancy is planned during the course of the investigation if patient is of child bearing potential.

Sponsors & Collaborators

• samir kapadia: lead
• Boston Scientific Corporation: collaborator
• The Cleveland Clinic: collaborator

Study Sites (32)

Banner University Medical Center

Phoenix, Arizona, 85006, United States

Location

Sutter Health/Palo Alto Medical Foundation

Burlingame, California, 94010, United States

Location

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States

Location

UCHealth Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Baptist Health Jacksonville

Jacksonville, Florida, 32207, United States

Location

Northside Hospital

St. Petersburg, Florida, 33709, United States

Location

Tallahassee Research Institute

Tallahassee, Florida, 32308, United States

Location

Prairie Cardiovascular Consultants

Springfield, Illinois, 62701, United States

Location

Parkview Research Center

Fort Wayne, Indiana, 46845, United States

Location

St. Vincent Heart Center

Indianapolis, Indiana, 46290, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Ascension St. John Hospital

Detroit, Michigan, 48236, United States

Location

Medstar Washington University

St Louis, Missouri, 63110, United States

Location

CHI Health Research Center

Omaha, Nebraska, 68124, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

University at Buffalo

Buffalo, New York, 14203, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

OhioHealth Research Institute

Columbus, Ohio, 43214, United States

Location

INTEGRIS Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

Pinnacle Health

Wormleysburg, Pennsylvania, 17043, United States

Location

WellSpan York Hospital

York, Pennsylvania, 17403, United States

Location

Lexington Cardiology

West Columbia, South Carolina, 29169, United States

Location

Austin Heart

Austin, Texas, 78756, United States

Location

Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Aspirus Research Institute

Wausau, Wisconsin, 54401, United States

Location

Related Publications (1)

• 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.

  PMID: 37874908 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction

Results Point of Contact

• Title: Samir Kapadia, MD Chairman Cardiovascular Medicine
• Organization: Cleveland Clinic

KAPADIS@ccf.org

216 444-6735

Study Officials

• Samir Kapadia, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Principal Investigator

Model Details: Patients will be randomized in a 1:1 allocation ratio to the following treatment arms TAVR + Medical Therapy (n=175) or simultaneous TAVR + WATCHMAN (n=175)

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: June 2, 2017
• Study Start: December 15, 2017
• Primary Completion: December 6, 2022
• Study Completion: December 6, 2022
• Last Updated: May 22, 2024
• Results First Posted: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (32)