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

Not Applicable

Completed

Conditions: Atrial Fibrillation
Aortic Valve Stenosis

Interventions: Device: WATCHMAN
Device: TAVR

Registration Number: NCT03173534

Lead Sponsor: samir kapadia

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 350

Inclusion Criteria

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.

Exclusion Criteria

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.

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.
  1. The patient is actively enrolled in another trial of a cardiovascular device or an investigational drug (post-market study participation and registries are acceptable).
  2. The patient is pregnant or pregnancy is planned during the course of the investigation if patient is of child bearing potential.
  3. 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.
  4. The patient has a life expectancy of less than two years.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAVR + WATCHMAN	TAVR	n=177 will undergo simultaneous Transcatheter Aortic Valve Replacement (TAVR) with a WATCHMAN device.
TAVR + Medical Therapy	TAVR	n=172 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation
TAVR + WATCHMAN	WATCHMAN	n=177 will undergo simultaneous Transcatheter Aortic Valve Replacement (TAVR) with a WATCHMAN device.

Primary Outcome Measures

Name	Time	Method
Composite of All-cause Mortality, Stroke and Bleeding	Through 2 year post-randomization	First occurrence of all-cause mortality, stroke (ischemic or hemorrhagic), or bleeding (life-threatening and major) events through 2 years post-randomization.

Secondary Outcome Measures

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

Trial Locations

Locations (32): Medstar Washington University
🇺🇸
Saint Louis, Missouri, United States
Pinnacle Health
🇺🇸
Wormleysburg, Pennsylvania, United States
University at Buffalo
🇺🇸
Buffalo, New York, United States
Lexington Cardiology
🇺🇸
West Columbia, South Carolina, United States
Inova Fairfax Hospital
🇺🇸
Falls Church, Virginia, United States
Austin Heart
🇺🇸
Austin, Texas, United States
Morristown Medical Center
🇺🇸
Morristown, New Jersey, United States
Columbia University Medical Center
🇺🇸
New York, New York, United States
Intermountain Medical Center
🇺🇸
Murray, Utah, United States
Heart Hospital Baylor Plano
🇺🇸
Plano, Texas, United States
Aspirus Research Institute
🇺🇸
Wausau, Wisconsin, United States
The Ohio State University
🇺🇸
Columbus, Ohio, United States
OhioHealth Research Institute
🇺🇸
Columbus, Ohio, United States
WellSpan York Hospital
🇺🇸
York, Pennsylvania, 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
Baptist Health Jacksonville
🇺🇸
Jacksonville, Florida, United States
Medstar Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
Northside Hospital
🇺🇸
Saint 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
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
The Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Banner University Medical Center
🇺🇸
Phoenix, Arizona, United States
Henry Ford Hospital
🇺🇸
Detroit, Michigan, United States
Ascension St. John Hospital
🇺🇸
Detroit, Michigan, United States
CHI Health Research Center
🇺🇸
Omaha, Nebraska, United States
INTEGRIS Baptist Medical Center
🇺🇸
Oklahoma City, Oklahoma, United States
University of Iowa Hospitals and Clinics
🇺🇸
Iowa City, Iowa, United States