Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy - Full Text View

Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy (PREVAIL)

This study is currently recruiting participants.

Verified April 2012 by Atritech

First Received on August 12, 2010. Last Updated on April 19, 2012 History of Changes

Sponsor:	Atritech
Information provided by (Responsible Party):	Atritech
ClinicalTrials.gov Identifier:	NCT01182441

Purpose

This is a prospective, randomized, multicenter study to provide additional information on the safety and efficacy of the WATCHMAN LAA Closure Technology.

Condition	Intervention	Phase
Atrial Fibrillation Stroke	Device: WATCHMAN Device Drug: Warfarin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Blood Thinners

Drug Information available for: Warfarin Warfarin sodium

U.S. FDA Resources

Further study details as provided by Atritech:

Primary Outcome Measures:

Primary Efficacy Endpoint [ Time Frame: 6-Months ] [ Designated as safety issue: Yes ]
The occurance of stroke, cardiovascular death and systemic embolism.

Estimated Enrollment:	475
Study Start Date:	November 2010
Estimated Study Completion Date:	November 2015
Estimated Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: WATCHMAN Subjects assigned to receive the WATCHMAN device.	Device: WATCHMAN Device WATCHMAN Left Atrial Appendage Closure Technology
Active Comparator: Warfarin Subjects assigned to warfarin therapy.	Drug: Warfarin Warfarin dosage prescribed by study physician to adequately maintain an INR of 2.0-3.0 Other Name: Coumadin

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria:

Paroxysmal, persistent or permanent non-valvular AF
Eligible for long-term warfarin therapy
Eligible to come off warfarin therapy
Calculated CHADS2 score of 2 or greater. Also patients with a CHADS2 score of 1 may be included if any of the following apply:
- Female age 75 or older
- Baseline LVEF ≥ 30 and < 35%
- Aged 65-74 and has diabetes or coronary artery disease
- Aged 65 or greater and has congestive heart failure

Key Exclusion Criteria:

Contraindicated/allergic to aspirin
Indicated for clopidogrel therapy or has taken clopidogrel within 7 days prior to enrollment
History of atrial septal repair or has an ASD/PFO device
Implanted mechanical valve prosthesis
NYHA Class IV CHF
Resting heart rate > 110 bpm
Participated previously in the PROTECT AF or CAP Registry studies

Key Echo Exclusion Criteria:

LVEF < 30%
Existing pericardial effusion > 2mm
High risk PFO
Significant mitral valve stenosis
Complex atheroma with mobile plaque of the descending aorta and/or aortic arch
Cardiac tumor

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01182441

Show 41 Study Locations

Sponsors and Collaborators

Atritech

Investigators

Principal Investigator:	David R. Holmes, M.D.	Mayo Clinic
Principal Investigator:	Vivek Y. Reddy, M.D.	Mount Sinai School of Medicine

More Information

No publications provided

Responsible Party:	Atritech
ClinicalTrials.gov Identifier:	NCT01182441 History of Changes
Other Study ID Numbers:	CT1004
Study First Received:	August 12, 2010
Last Updated:	April 19, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Atritech:

atrial fibrillation
stroke
TIA

trans ischemic attack
warfarin
Coumadin

Additional relevant MeSH terms:

Atrial Fibrillation
Stroke
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2012