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Trial record 1 of 1 for:    NCT03173534
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WATCH-TAVR, WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement

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ClinicalTrials.gov Identifier: NCT03173534
Recruitment Status : Recruiting
First Posted : June 2, 2017
Last Update Posted : November 13, 2019
Sponsor:
Collaborators:
Boston Scientific Corporation
The Cleveland Clinic
Information provided by (Responsible Party):
Samir Kapadia, The Cleveland Clinic

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
Atrial Fibrillation Aortic Valve Stenosis Device: WATCHMAN Device: TAVR Not Applicable

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 25 centers in the United States. There will be up to 312 subjects enrolled, with 156 patients randomized to TAVR + medical therapy and 156 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 312 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=156) or simultaneous TAVR + WATCHMAN (n=156)
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Active Comparator: TAVR + Medical Therapy
n=156 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation
Device: TAVR
Transcatheter Aortic Valve Replacement

Experimental: TAVR + WATCHMAN
n=156 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




Primary Outcome Measures :
  1. Composite of all-cause mortality, stroke and bleeding [ Time Frame: 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 [ Time Frame: Through 1 year post-randomization ]
    All deaths through 1 year

  2. Stroke [ Time Frame: Through 1 year post-randomization ]
    First occurrence of any ischemic or hemorrhagic stroke through 1 year

  3. Bleeding [ Time Frame: Through 1 year post-randomization ]
    First occurrence of any life-threatening or major bleeding through 1 year


Other Outcome Measures:
  1. Cardiovascular mortality [ Time Frame: Through 1 year post-randomization ]
    Cardiovascular related mortality through 1 year

  2. Thrombus or embolism [ Time Frame: Through 1 year post-randomization ]
    Incidence of arterial or venous embolism

  3. Re-hospitalization [ Time Frame: Through 1 year post-randomization ]
    Incidence of re-hospitalizations related to the WATCHMAN procedure or device

  4. Quality of Life Score: KCCQ-12 [ Time Frame: 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 [ Time Frame: from initial hospitalization to discharge ]
    Procedural costs related to the initial TAVR and WATCHMAN procedures



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03173534


Contacts
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Contact: Allison Kirkholder, BSN 216.445.8070 kirkhoa@ccf.org
Contact: Ellen S McErlean, MSN 216-445-7177 mcerlee@ccf.org

Locations
Show Show 23 study locations
Sponsors and Collaborators
Samir Kapadia
Boston Scientific Corporation
The Cleveland Clinic
Investigators
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Principal Investigator: Samir Kapadia, MD The Cleveland Clinic

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Responsible Party: Samir Kapadia, Study Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03173534    
Other Study ID Numbers: WATCH-TAVR
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Atrial Fibrillation
Aortic Valve Stenosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Valve Diseases
Ventricular Outflow Obstruction