Clinical trial NCT03173534: WATCH-TAVR, WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement
Official title: WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Aortic Valve Stenosis
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
name: The Cleveland Clinic
First posted: 2017-06-02
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Composite of All-cause Mortality, Stroke and Bleeding
timeFrame: Through 2 year post-randomization
Secondary outcomes:
measure: All-cause Mortality
timeFrame: Through 2 year post-randomization
measure: Stroke
timeFrame: Through 2 year post-randomization
measure: Bleeding
timeFrame: Through 2 year post-randomization
Other outcomes:
measure: Cardiovascular Mortality
timeFrame: Through 2 year post-randomization
measure: Thrombus or Embolism
timeFrame: Through 2 year post-randomization
measure: Re-hospitalization
timeFrame: Through 2 year post-randomization
measure: Quality of Life Score: KCCQ-12
timeFrame: Through 2 year post-randomization
measure: Procedural Costs
timeFrame: Mean cost during hospitalization up to 40 days.
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center
state: Arizona
city: Burlingame
country: United States
facility: Sutter Health/Palo Alto Medical Foundation
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
city: Loveland
country: United States
facility: UCHealth Medical Center of the Rockies
state: Colorado
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Jacksonville
country: United States
facility: Baptist Health Jacksonville
state: Florida
city: Saint Petersburg
country: United States
facility: Northside Hospital
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute
state: Florida
city: Springfield
country: United States
facility: Prairie Cardiovascular Consultants
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Research Center
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Heart Center
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: Ascension St. John Hospital
state: Michigan
city: Saint Louis
country: United States
facility: Medstar Washington University
state: Missouri
city: Omaha
country: United States
facility: CHI Health Research Center
state: Nebraska
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Research Institute
state: Ohio
city: Oklahoma City
country: United States
facility: INTEGRIS Baptist Medical Center
state: Oklahoma
city: Wormleysburg
country: United States
facility: Pinnacle Health
state: Pennsylvania
city: York
country: United States
facility: WellSpan York Hospital
state: Pennsylvania
city: West Columbia
country: United States
facility: Lexington Cardiology
state: South Carolina
city: Austin
country: United States
facility: Austin Heart
state: Texas
city: Plano
country: United States
facility: Heart Hospital Baylor Plano
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Wausau
country: United States
facility: Aspirus Research Institute
state: Wisconsin
Study officials:
affiliation: The Cleveland Clinic
name: Samir Kapadia, MD
role: PRINCIPAL_INVESTIGATOR
References: