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Atrial FibrillationNCT03173534

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

A study testing WATCHMAN and TAVR in people with Atrial Fibrillation and Aortic Valve Stenosis, run by samir kapadia at 32 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation, Aortic Valve Stenosis
What is being tested?
WATCHMAN and TAVR
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
32 sitesUnited States
Study dates
15 Dec 2017to 6 Dec 2022
Phase
Interventional

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

  • 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.

Who cannot join

  • The patient had a stroke or TIA within the last 6 months prior to enrollment.
  • 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.
Show all 17Show fewer
  • 7. 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.
  • 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.

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

United States32 sites

  • Austin Heart

    Austin, Texas, 78756

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • University at Buffalo

    Buffalo, New York, 14203

  • Sutter Health/Palo Alto Medical Foundation

    Burlingame, California, 94010

  • The Cleveland Clinic

    Cleveland, Ohio, 44195

  • The Ohio State University

    Columbus, Ohio, 43210

  • OhioHealth Research Institute

    Columbus, Ohio, 43214

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Ascension St. John Hospital

    Detroit, Michigan, 48236

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Parkview Research Center

    Fort Wayne, Indiana, 46845

  • St. Vincent Heart Center

    Indianapolis, Indiana, 46290

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Baptist Health Jacksonville

    Jacksonville, Florida, 32207

  • UCHealth Medical Center of the Rockies

    Loveland, Colorado, 80538

  • Morristown Medical Center

    Morristown, New Jersey, 07960

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Columbia University Medical Center

    New York, New York, 10032

  • INTEGRIS Baptist Medical Center

    Oklahoma City, Oklahoma, 73112

  • CHI Health Research Center

    Omaha, Nebraska, 68124

  • Banner University Medical Center

    Phoenix, Arizona, 85006

  • Heart Hospital Baylor Plano

    Plano, Texas, 75093

  • Santa Barbara Cottage Hospital

    Santa Barbara, California, 93105

  • Prairie Cardiovascular Consultants

    Springfield, Illinois, 62701

  • Medstar Washington University

    St Louis, Missouri, 63110

  • Northside Hospital

    St. Petersburg, Florida, 33709

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308

  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Aspirus Research Institute

    Wausau, Wisconsin, 54401

  • Lexington Cardiology

    West Columbia, South Carolina, 29169

  • Pinnacle Health

    Wormleysburg, Pennsylvania, 17043

  • WellSpan York Hospital

    York, Pennsylvania, 17403

Other trials in United States

About this study

Official title: WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement

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).

Read the 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.

Being tested
WATCHMAN, TAVR
Medical subject headings
Atrial Fibrillation, Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WATCHMANDevice

    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.

  • TAVRDevice

    Transcatheter Aortic Valve Replacement

Study groups in NCT03173534
Study groupRoleWhat they receive
TAVR + Medical TherapyActive comparatorn=172 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation
Receives: Device: TAVR
TAVR + WATCHMANExperimentaln=177 will undergo simultaneous Transcatheter Aortic Valve Replacement (TAVR) with a WATCHMAN device.
Receives: Device: WATCHMAN; Device: TAVR

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Through 2 year post-randomization

Secondary outcomes (3)

  1. All-cause Mortality

    All deaths through 2 year

    Measured: Through 2 year post-randomization

  2. Stroke

    First occurrence of any ischemic or hemorrhagic stroke through 2 year

    Measured: Through 2 year post-randomization

  3. Bleeding

    First occurrence of any life-threatening or major bleeding through 2 year

    Measured: Through 2 year post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2017
  2. Study start15 Dec 2017
  3. Primary completion6 Dec 2022
  4. Study completion6 Dec 2022

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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)
Masking
None (open label)
Enrolment
350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03173534
Sponsor's protocol ID
WATCH-TAVR
Status last verified
May 2024
First submitted
23 May 2017
Last updated
22 May 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 37874908

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