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

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).

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Aortic Valve Stenosis
• Intervention / Treatment: Device: TAVR; Device: WATCHMAN

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.

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner University Medical Center
  • California
    • Burlingame, California, United States, 94010
      • Sutter Health/Palo Alto Medical Foundation
    • Santa Barbara, California, United States, 93105
      • Santa Barbara Cottage Hospital
  • Colorado
    • Loveland, Colorado, United States, 80538
      • UCHealth Medical Center of the Rockies
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Baptist Health Jacksonville
    • Saint Petersburg, Florida, United States, 33709
      • Northside Hospital
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Research Institute
  • Illinois
    • Springfield, Illinois, United States, 62701
      • Prairie Cardiovascular Consultants
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Parkview Research Center
    • Indianapolis, Indiana, United States, 46290
      • St. Vincent Heart Center
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48236
      • Ascension St. John Hospital
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Medstar Washington University
  • Nebraska
    • Omaha, Nebraska, United States, 68124
      • CHI Health Research Center
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Morristown Medical Center
  • New York
    • Buffalo, New York, United States, 14203
      • University at Buffalo
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
    • Columbus, Ohio, United States, 43214
      • OhioHealth Research Institute
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • INTEGRIS Baptist Medical Center
  • Pennsylvania
    • Wormleysburg, Pennsylvania, United States, 17043
      • Pinnacle Health
    • York, Pennsylvania, United States, 17403
      • Wellspan York Hospital
  • South Carolina
    • West Columbia, South Carolina, United States, 29169
      • Lexington Cardiology
  • Texas
    • Austin, Texas, United States, 78756
      • Austin Heart
    • Plano, Texas, United States, 75093
      • Heart Hospital Baylor Plano
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital
  • Wisconsin
    • Wausau, Wisconsin, United States, 54401
      • Aspirus Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TAVR + Medical Therapy; n=172 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation	Device: TAVR; Transcatheter Aortic Valve Replacement
Experimental: TAVR + WATCHMAN; n=177 will undergo simultaneous Transcatheter Aortic Valve Replacement (TAVR) with a WATCHMAN device.	Device: TAVR; Transcatheter Aortic Valve Replacement; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause Mortality	All deaths through 2 year	Through 2 year post-randomization
Stroke	First occurrence of any ischemic or hemorrhagic stroke through 2 year	Through 2 year post-randomization
Bleeding	First occurrence of any life-threatening or major bleeding through 2 year	Through 2 year post-randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular Mortality	Cardiovascular related mortality through 2 year	Through 2 year post-randomization
Thrombus or Embolism	Incidence of arterial or venous embolism	Through 2 year post-randomization
Re-hospitalization	Incidence of re-hospitalizations related to the WATCHMAN procedure or WATCHMAN device	Through 2 year post-randomization
Quality of Life Score: KCCQ-12	Change from baseline in quality of life (QoL) as measured using the KCCQ-12 score. Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated tool used to assess heart failure and how it affects the participant's life. Four domain scores and one summary score are generated from the KCCQ-12: Physical Limitation Score, Symptom Frequency Score, Quality of Life Score, Social Limitation Score and a Summary Score. Scale ranges for each question 1 to 6 (Extremely limited 1, Quite a bit limited 2, Moderately limited 3, Slightly limited 4, Not at all limited 5, Limited for other reasons or did not do the activity 6. The Summary score represents an integration of the patient's physical limitation, symptom frequency, quality of life and social limitation. The total score is calculated as the average of the above scale descriptions. Scores are scaled 0-100, where 0 denotes the lowest reportable health status. Scores of 100 indicate the highest reportable health better outcome status.	Through 2 year post-randomization
Procedural Costs	Procedural costs related to the initial TAVR and WATCHMAN procedures	Mean cost during hospitalization up to 40 days.

Collaborators and Investigators

• Sponsor: samir kapadia
• Collaborators: The Cleveland Clinic; Boston Scientific Corporation
• Investigators: Principal Investigator: Samir Kapadia, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2017
• Primary Completion (Actual): December 6, 2022
• Study Completion (Actual): December 6, 2022

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: May 31, 2017
• First Posted (Actual): June 2, 2017

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 19, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Atrial Fibrillation; Aortic Valve Stenosis
• Other Study ID Numbers: WATCH-TAVR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No