Purpose

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).

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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.
  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:
  8. Secondary to conditions such as prior arterial embolism or other indications such as pulmonary embolism or deep vein thrombosis within the previous 6 months
  9. The patient is in a hypercoaguable state; exclude the patient if per medical record documentation, the patient meets any of the following criteria:
  10. Thrombosis occurring ≤ 40 years of age
  11. Idiopathic or recurrent VTE (venous thrombo-embolism)
  12. Thrombosis at an unusual site (cerebral veins, hepatic veins, renal veins, IVC, mesenteric veins)
  13. Family history of VTE or of inherited prothrombotic disorder, recurrence/extension of thrombosis while adequately anticoagulated.
  14. The patient is actively enrolled in another trial of a cardiovascular device or an investigational drug (post-market study participation and registries are acceptable).
  15. The patient is pregnant or pregnancy is planned during the course of the investigation if patient is of child bearing potential.
  16. 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.
  17. The patient has a life expectancy of less than two years.

Study Design

Phase
N/A
Study Type
Interventional
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)
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Banner University Medical Center
Phoenix, Arizona 85006
Contact:
Elena Young
602-827-9963
ELENAY@EMAIL.ARIZONA.EDU

More Details

NCT ID
NCT03173534
Status
Recruiting
Sponsor
Samir Kapadia

Study Contact

Allison Kirkholder, BSN
216.445.8070
kirkhoa@ccf.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.