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

May 19, 2024 updated by: samir kapadia

WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner University Medical Center
    • California
      • Burlingame, California, United States, 94010
        • Sutter Health/Palo Alto Medical Foundation
      • Santa Barbara, California, United States, 93105
        • Santa Barbara Cottage Hospital
    • Colorado
      • Loveland, Colorado, United States, 80538
        • UCHealth Medical Center of the Rockies
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • MedStar Washington Hospital Center
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist Health Jacksonville
      • Saint Petersburg, Florida, United States, 33709
        • Northside Hospital
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Research Institute
    • Illinois
      • Springfield, Illinois, United States, 62701
        • Prairie Cardiovascular Consultants
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Parkview Research Center
      • Indianapolis, Indiana, United States, 46290
        • St. Vincent Heart Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48236
        • Ascension St. John Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Medstar Washington University
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • CHI Health Research Center
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Morristown Medical Center
    • New York
      • Buffalo, New York, United States, 14203
        • University at Buffalo
      • New York, New York, United States, 10032
        • Columbia University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
      • Columbus, Ohio, United States, 43214
        • OhioHealth Research Institute
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • INTEGRIS Baptist Medical Center
    • Pennsylvania
      • Wormleysburg, Pennsylvania, United States, 17043
        • Pinnacle Health
      • York, Pennsylvania, United States, 17403
        • Wellspan York Hospital
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
        • Lexington Cardiology
    • Texas
      • Austin, Texas, United States, 78756
        • Austin Heart
      • Plano, Texas, United States, 75093
        • Heart Hospital Baylor Plano
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital
    • Wisconsin
      • Wausau, Wisconsin, United States, 54401
        • Aspirus Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: TAVR + Medical Therapy
n=172 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation
Device: TAVR
Transcatheter Aortic Valve Replacement
Experimental: TAVR + WATCHMAN
n=177 will undergo simultaneous Transcatheter Aortic Valve Replacement (TAVR) with a WATCHMAN device.
Device: TAVR
Transcatheter Aortic Valve Replacement
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite of All-cause Mortality, Stroke and Bleeding
Time Frame: Through 2 year post-randomization
First occurrence of all-cause mortality, stroke (ischemic or hemorrhagic), or bleeding (life-threatening and major) events through 2 years post-randomization.
Through 2 year post-randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All-cause Mortality
Time Frame: Through 2 year post-randomization
All deaths through 2 year
Through 2 year post-randomization
Stroke
Time Frame: Through 2 year post-randomization
First occurrence of any ischemic or hemorrhagic stroke through 2 year
Through 2 year post-randomization
Bleeding
Time Frame: Through 2 year post-randomization
First occurrence of any life-threatening or major bleeding through 2 year
Through 2 year post-randomization

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cardiovascular Mortality
Time Frame: Through 2 year post-randomization
Cardiovascular related mortality through 2 year
Through 2 year post-randomization
Thrombus or Embolism
Time Frame: Through 2 year post-randomization
Incidence of arterial or venous embolism
Through 2 year post-randomization
Re-hospitalization
Time Frame: Through 2 year post-randomization
Incidence of re-hospitalizations related to the WATCHMAN procedure or WATCHMAN device
Through 2 year post-randomization
Quality of Life Score: KCCQ-12
Time Frame: Through 2 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 total score is calculated as the average of the above scale descriptions. Scores are scaled 0-100, where 0 denotes the lowest reportable health status. Scores of 100 indicate the highest reportable health better outcome status.
Through 2 year post-randomization
Procedural Costs
Time Frame: Mean cost during hospitalization up to 40 days.
Procedural costs related to the initial TAVR and WATCHMAN procedures
Mean cost during hospitalization up to 40 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
samir kapadia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Cleveland Clinic
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Samir Kapadia, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 6, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 6, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WATCH-TAVR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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