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

• ClinicalTrials.gov Identifier: NCT03173534
• Recruitment Status: Completed
• First Posted: June 2, 2017
• Last Update Posted: August 30, 2023
• Sponsor: samir kapadia
• Collaborators: Boston Scientific Corporation; The Cleveland Clinic
• Information provided by (Responsible Party): samir kapadia, The Cleveland Clinic

Tracking Information

• First Submitted Date: May 23, 2017
• First Posted Date: June 2, 2017
• Last Update Posted Date: August 30, 2023
• Actual Study Start Date: December 15, 2017
• Actual Primary Completion Date: December 6, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 11, 2018)

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

Original Primary Outcome Measures (submitted: May 31, 2017)

Composite of all-cause mortality, stroke and bleeding [ Time Frame: Through 1 year post-procedure ]

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

Current Secondary Outcome Measures (submitted: January 11, 2018)

• All-cause mortality [ Time Frame: Through 1 year post-randomization ]
  All deaths through 1 year
• Stroke [ Time Frame: Through 1 year post-randomization ]
  First occurrence of any ischemic or hemorrhagic stroke through 1 year
• Bleeding [ Time Frame: Through 1 year post-randomization ]
  First occurrence of any life-threatening or major bleeding through 1 year

Original Secondary Outcome Measures (submitted: May 31, 2017)

• All-cause mortality [ Time Frame: Through 1 year post-procedure ]
  All deaths through 1 year
• Stroke [ Time Frame: Through 1 year post-procedure ]
  First occurrence of any ischemic or hemorrhagic stroke through 1 year
• Bleeding [ Time Frame: Through 1 year post-procedure ]
  First occurrence of any life-threatening or major bleeding through 1 year

Current Other Pre-specified Outcome Measures (submitted: October 28, 2018)

• Cardiovascular mortality [ Time Frame: Through 1 year post-randomization ]
  Cardiovascular related mortality through 1 year
• Thrombus or embolism [ Time Frame: Through 1 year post-randomization ]
  Incidence of arterial or venous embolism
• Re-hospitalization [ Time Frame: Through 1 year post-randomization ]
  Incidence of re-hospitalizations related to the WATCHMAN procedure or device
• 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
• Procedural costs [ Time Frame: from initial hospitalization to discharge ]
  Procedural costs related to the initial TAVR and WATCHMAN procedures

Original Other Pre-specified Outcome Measures (submitted: May 31, 2017)

• Cardiovascular mortality [ Time Frame: Through 1 year post-procedure ]
  Cardiovascular related mortality through 1 year
• Thrombus or embolism [ Time Frame: Through 1 year post-procedure ]
  Incidence of arterial or venous embolism
• Re-hospitalization [ Time Frame: Through 1 year post-procedure ]
  Incidence of re-hospitalizations related to the WATCHMAN procedure or device
• Quality of Life [ Time Frame: Through 1 year post-procedure ]
  Change from baseline in quality of life (QoL) as measured using the KCCQ-12 score
• Procedural costs [ Time Frame: Initial procedure ]
  Procedural costs related to the initial TAVR and WATCHMAN procedures

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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)

Masking: None (Open Label)
Primary Purpose: Prevention

Condition

• Atrial Fibrillation
• Aortic Valve Stenosis

Intervention

• 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

Study Arms

• Active Comparator: TAVR + Medical Therapy
  n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation
  Intervention: Device: TAVR
• Experimental: TAVR + WATCHMAN
  n=175 will undergo simultaneous Transcatheter Aortic Valve Replacement (TAVR) with a WATCHMAN device.
  Interventions:

  • Device: WATCHMAN
  • Device: TAVR

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 29, 2023): 349
• Original Estimated Enrollment (submitted: May 31, 2017): 400
• Actual Study Completion Date: December 6, 2022
• Actual Primary Completion Date: December 6, 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03173534
• Other Study ID Numbers: WATCH-TAVR
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: samir kapadia, The Cleveland Clinic
• Original Responsible Party: Samir Kapadia, The Cleveland Clinic, Study Principal Investigator
• Current Study Sponsor: samir kapadia
• Original Study Sponsor: Samir Kapadia

Collaborators

• Boston Scientific Corporation
• The Cleveland Clinic

Investigators

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

• PRS Account: The Cleveland Clinic
• Verification Date: August 2023