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

Sponsor
Samir Kapadia (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03173534
Collaborator
Boston Scientific Corporation (Industry), The Cleveland Clinic (Other)
350
Enrollment
32
Locations
2
Arms
58.5
Anticipated Duration (Months)
10.9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: WATCHMAN
  • Device: TAVR
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
350 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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)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)
Primary Purpose:
Prevention
Official Title:
WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement
Actual Study Start Date :
Dec 15, 2017
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: TAVR + Medical Therapy

n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation

Device: TAVR
Transcatheter Aortic Valve Replacement
Experimental: TAVR + WATCHMAN

n=175 will undergo simultaneous Transcatheter Aortic Valve Replacement (TAVR) with a WATCHMAN device.

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.

Device: TAVR
Transcatheter Aortic Valve Replacement

Outcome Measures

Primary Outcome Measures

  1. Composite of all-cause mortality, stroke and bleeding [Through 1 year post-randomization]

    First occurrence of all-cause mortality, stroke (ischemic or hemorrhagic), or bleeding (life-threatening and major) events through 1 year

Secondary Outcome Measures

  1. All-cause mortality [Through 1 year post-randomization]

    All deaths through 1 year

  2. Stroke [Through 1 year post-randomization]

    First occurrence of any ischemic or hemorrhagic stroke through 1 year

  3. Bleeding [Through 1 year post-randomization]

    First occurrence of any life-threatening or major bleeding through 1 year

Other Outcome Measures

  1. Cardiovascular mortality [Through 1 year post-randomization]

    Cardiovascular related mortality through 1 year

  2. Thrombus or embolism [Through 1 year post-randomization]

    Incidence of arterial or venous embolism

  3. Re-hospitalization [Through 1 year post-randomization]

    Incidence of re-hospitalizations related to the WATCHMAN procedure or device

  4. Quality of Life Score: KCCQ-12 [Through 1 year post-randomization]

    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 score is calculated as the average. Scores are scaled 0-100, where 0 denotes the lowest reportable health status and 100 the highest

  5. Procedural costs [from initial hospitalization to discharge]

    Procedural costs related to the initial TAVR and WATCHMAN procedures

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

  1. 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).

  2. Prior occlusion of LAA.

  3. The patient has an implanted mechanical mitral valve.

  4. The patient requires long-term warfarin therapy due to:

  5. Secondary to conditions such as prior arterial embolism or other indications such as pulmonary embolism or deep vein thrombosis within the previous 6 months

  6. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Banner University Medical Center Phoenix Arizona United States 85006
2 Sutter Health/Palo Alto Medical Foundation Burlingame California United States 94010
3 Santa Barbara Cottage Hospital Santa Barbara California United States 93105
4 UCHealth Medical Center of the Rockies Loveland Colorado United States 80538
5 Medstar Washington Hospital Center Washington District of Columbia United States 20010
6 Baptist Health Jacksonville Jacksonville Florida United States 32207
7 Northside Hospital Saint Petersburg Florida United States 33709
8 Tallahassee Research Institute Tallahassee Florida United States 32308
9 Prairie Cardiovascular Consultants Springfield Illinois United States 62701
10 Parkview Research Center Fort Wayne Indiana United States 46845
11 St. Vincent Heart Center Indianapolis Indiana United States 46290
12 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
13 Massachusetts General Hospital Boston Massachusetts United States 02114
14 Henry Ford Hospital Detroit Michigan United States 48202
15 Ascension St. John Hospital Detroit Michigan United States 48236
16 Medstar Washington University Saint Louis Missouri United States 63110
17 CHI Health Research Center Omaha Nebraska United States 68124
18 Morristown Medical Center Morristown New Jersey United States 07960
19 University at Buffalo Buffalo New York United States 14203
20 Columbia University Medical Center New York New York United States 10032
21 The Cleveland Clinic Cleveland Ohio United States 44195
22 The Ohio State University Columbus Ohio United States 43210
23 OhioHealth Research Institute Columbus Ohio United States 43214
24 INTEGRIS Baptist Medical Center Oklahoma City Oklahoma United States 73112
25 Pinnacle Health Wormleysburg Pennsylvania United States 17043
26 WellSpan York Hospital York Pennsylvania United States 17403
27 Lexington Cardiology West Columbia South Carolina United States 29169
28 Austin Heart Austin Texas United States 78756
29 Heart Hospital Baylor Plano Plano Texas United States 75093
30 Intermountain Medical Center Murray Utah United States 84107
31 Inova Fairfax Hospital Falls Church Virginia United States 22042
32 Aspirus Research Institute Wausau Wisconsin United States 54401

Sponsors and Collaborators

  • Samir Kapadia
  • Boston Scientific Corporation
  • The Cleveland Clinic

Investigators

  • Principal Investigator: Samir Kapadia, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Samir Kapadia, Study Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT03173534
Other Study ID Numbers:
  • WATCH-TAVR
First Posted:
Jun 2, 2017
Last Update Posted:
Feb 21, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Atrial Fibrillation
Aortic Valve Stenosis

Study Results

No Results Posted as of Feb 21, 2022