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

Completed · Not applicable

Conditions studied: Atrial Fibrillation, Aortic Valve Stenosis

In brief

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).

Key facts

Study ID

NCT03173534

Run by

samir kapadia

People needed

350

Starts

2017-12-15

Expected to finish

2022-12-06

Last updated by the study team

2024-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women ≥ 18 years of age.
• The patient meets criteria for and is scheduled to undergo TAVR procedure
• The patient has documented paroxysmal, persistent, or permanent atrial fibrillation.
• The patient meets the WATCHMAN labeling guidelines and is eligible to undergo the WATCHMAN implantation procedure.
• The patient is eligible for short term warfarin therapy.
• The patient or legal representative is able to understand and willing to provide written informed consent to participate in the trial.
• The patient is able and willing to return for required follow-up visits and examinations.

You may not qualify if…

• The patient had a stroke or TIA within the last 6 months prior to enrollment.
• 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.
• 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).
• Prior occlusion of LAA.
• The patient has an implanted mechanical mitral valve.
• The patient requires long-term warfarin therapy due to:
• Secondary to conditions such as prior arterial embolism or other indications such as pulmonary embolism or deep vein thrombosis within the previous 6 months
• 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.
• The patient is actively enrolled in another trial of a cardiovascular device or an investigational drug (post-market study participation and registries are acceptable).
• The patient is pregnant or pregnancy is planned during the course of the investigation if patient is of child bearing potential.
• 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.
• The patient has a life expectancy of less than two years.

Where it is running

• Banner University Medical Center — Phoenix, Arizona, United States
• Sutter Health/Palo Alto Medical Foundation — Burlingame, California, United States
• Santa Barbara Cottage Hospital — Santa Barbara, California, United States
• UCHealth Medical Center of the Rockies — Loveland, Colorado, United States
• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Baptist Health Jacksonville — Jacksonville, Florida, United States
• Northside Hospital — St. Petersburg, Florida, United States
• Tallahassee Research Institute — Tallahassee, Florida, United States
• Prairie Cardiovascular Consultants — Springfield, Illinois, United States
• Parkview Research Center — Fort Wayne, Indiana, United States
• St. Vincent Heart Center — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Ascension St. John Hospital — Detroit, Michigan, United States
• Medstar Washington University — St Louis, Missouri, United States
• CHI Health Research Center — Omaha, Nebraska, United States
• Morristown Medical Center — Morristown, New Jersey, United States
• University at Buffalo — Buffalo, New York, United States
• Columbia University Medical Center — New York, New York, United States
• The Cleveland Clinic — Cleveland, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• OhioHealth Research Institute — Columbus, Ohio, United States
• INTEGRIS Baptist Medical Center — Oklahoma City, Oklahoma, United States
• Pinnacle Health — Wormleysburg, Pennsylvania, United States

Full record on ClinicalTrials.gov

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