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Atrial FibrillationPhase 2/3NCT00129545

WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation

A Phase 2/3 study testing WATCHMAN Left Atrial Appendage Closure Technology and Warfarin in people with Atrial Fibrillation and Stroke, run by Boston Scientific Corporation at 62 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a multi-center, prospective, randomized study, stratified by center, comparing the WATCHMAN device to long term warfarin therapy, demonstrating that the treatment arm is non-inferior to the control arm. This study was amended to allow for a non-randomized arm and increased enrollment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation, Stroke
What is being tested?
WATCHMAN Left Atrial Appendage Closure Technology and Warfarin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
800 participants
Where
62 sitesin 3 countries
Study dates
Feb 2005to May 2014
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient has paroxysmal, persistent or permanent non-valvular atrial fibrillation (AF)
  • Eligible for long term warfarin
  • CHADS score >= 1 [congestive heart failure (CHF), history of high blood pressure, 75 years of age or older, diabetes, prior stroke or transient ischemic attack (TIA)]

Who cannot join

  • Contraindicated for warfarin
  • Contraindicated for aspirin or clopidogrel (Plavix)
  • Congestive heart failure (CHF) Class 4
  • Implanted mechanical valve
  • Atrial septal or Patent Foramen Ovale (PFO) device
  • Platelets < 100,000 or hemoglobin < 10
  • Left ventricular ejection fraction (LVEF) < 30%

Trial locations and contacts

62 sites in 3 countries.

62 sites in 3 countries

United States58 sites

  • Summa Health System

    Akron, Ohio, 44304

  • New Mexico Heart Institute

    Albuquerque, New Mexico, 87102

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109

  • Emory University Midtown Hospital

    Atlanta, Georgia, 30308

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Texas Cardiac Arrhythmia

    Austin, Texas, 78705

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Cooper University Hospital

    Camden, New Jersey, 08103

  • University of Virginia

    Charlottesville, Virginia, 22908

  • University of Chicago

    Chicago, Illinois, 60637

  • Lindner Clinical Trial Center

    Cincinnati, Ohio, 45219

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ohio State University

    Columbus, Ohio, 43210

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • North Shore University

    Evanston, Illinois, 60201

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Advanced Cardiac Specialists

    Gilbert, Arizona, 85233

  • Harrisburg Hospital / Associated Cardiology

    Harrisburg, Pennsylvania, 17110

  • Terrebonne General Medical Center

    Houma, Louisiana, 70360

  • St. Lukes Episcopal Hospital

    Houston, Texas, 77030

  • University of Mississippi Healthcare Center

    Jackson, Mississippi, 39216

  • St. Luke's Hospital

    Kansas City, Missouri, 64111

  • Mercy Medical Center West

    Knoxville, Tennessee, 37934

  • Foundation for Cardiovascular Medicine

    La Jolla, California, 92037

  • Baptist Hospital West

    Lexington, Kentucky, 40503

  • University of Kentucky

    Lexington, Kentucky, 40536-0294

  • Nebraska Heart Institute

    Lincoln, Nebraska, 68526

  • Los Angeles Cardiology Associates

    Los Angeles, California, 90017

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • University of Miami

    Miami, Florida, 33136

  • Baptist Cardiac and Vascular Institute

    Miami, Florida, 33176

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • El Camino Hospital

    Mountain View, California, 94040

  • St. Thomas Research Institute

    Nashville, Tennessee

  • Ochsner Clinic

    New Orleans, Louisiana, 70121

  • New York University Medical Center

    New York, New York, 10016

  • Columbia University Medical Center

    New York, New York, 10032

  • Mt. Sinai Medical Center

    New York, New York

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Orange County Heart

    Orange County, California, 92868

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Presbyterian University Hospital

    Pittsburgh, Pennsylvania, 15213

  • Mayo Clinic

    Rochester, Minnesota, 55902

  • William Beaumont

    Royal Oak, Michigan, 48073

  • UC Davis Medical Center

    Sacramento, California, 95817

  • St. Paul Heart Clinic

    Saint Paul, Minnesota, 55102

  • Intermountain Medical Center

    Salt Lake City, Utah, 84107

  • St. John's Hospital / Pacific Heart

    Santa Monica, California, 90404

  • Arizona Arrhythmia

    Scottsdale, Arizona, 85251

  • Swedish Medical Center

    Seattle, Washington, 98104

  • Prairie Education Research Cooperative

    Springfield, Illinois, 60637

  • Bay Heart Group

    Tampa, Florida, 33607

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Moffitt Heart & Vascular

    Wormleysburg, Pennsylvania, 17043

Other trials in United States

Germany3 sites

  • Cardiovasculares Centrum Frankfurt - Sankt Katharinen

    Frankfurt am Main, Hesse, 60389

  • Herzzentrum

    Leipzig

  • Krankenhaus der Barmherzige Bruder

    Regensburg, Bavaria, 93049

Other trials in Germany

Czechia1 site

  • Na Homolce

    Prague, 15030

Other trials in Czechia

About this study

Official title: WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF)

This is a multi-center, prospective, randomized study, stratified by center, comparing the WATCHMAN device to long term warfarin therapy, demonstrating that the treatment arm is non-inferior to the control arm. This study was amended to allow for a non-randomized arm and increased enrollment.

Read the detailed description

The WATCHMAN device is designed to be permanently implanted distal to the ostium of the left atrial appendage (LAA) to trap potential emboli before they exit the LAA.

Being tested
WATCHMAN Left Atrial Appendage Closure Technology, Warfarin
Keywords
Atrial Fibrillation, AF, A Fib, Stroke, Coumadin, Warfarin, Blood thinning medication, transient ischemic attack (TIA), WATCHMAN, Left atrial appendage, LAA isolation, LAA occlusion
Medical subject headings
Atrial Fibrillation, Stroke, Ischemic Attack, Transient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WATCHMAN Left Atrial Appendage Closure TechnologyDevice

    Also called WATCHMAN

    Implant of WATCHMAN Left Atrial Appendage Closure Technology

  • WarfarinDrug

    Also called Coumadin

    Subjects receive warfarin

Study groups in NCT00129545
Study groupRoleWhat they receive
WATCHMANExperimentalImplant of WATCHMAN Left Atrial Appendage Closure Technology
Receives: Device: WATCHMAN Left Atrial Appendage Closure Technology
Warfarin controlActive comparatorSubjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin
Receives: Drug: Warfarin
Roll-inOtherImplant of WATCHMAN Left Atrial Appendage Closure Technology. Up to 3 non-randomized subjects per site, these subjects were not included in the primary analysis.
Receives: Device: WATCHMAN Left Atrial Appendage Closure Technology

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death

    A Bayesian model allowed for sequential evaluation of the primary endpoints, event rates reported per 100 patient-years (calculated as 100*N events/Total patient-years)

    Measured: 5 years

  2. The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events

    Serious bleeding events evaluated by the Clinical Events Committee included pericardial effusion requiring drainage, cranial bleeding events due to any source, gastrointestinal bleeds requiring transfusion, and any bleeding related to the device or procedure that necessitates an operation.

    Measured: 5 years

Secondary outcomes (1)

  1. Procedure Success

    Implant procedure success is defined as the delivery and release of a WATCHMAN Device into the LAA.

    Measured: Initial implant procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2005 (estimated)
  2. Study startFeb 2005
  3. Primary completionAug 2013
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00129545
Sponsor's protocol ID
ST1021 and ST1055
Status last verified
Apr 2015
First submitted
10 Aug 2005
Last updated
15 May 2015
Data monitoring committee
Yes

Publications

  • Dukkipati SR, Holmes DR Jr, Doshi SK, Kar S, Singh SM, Gibson D, Price MJ, Natale A, Mansour M, Sievert H, Houle VM, Allocco DJ, Reddy VY. Impact of Peridevice Leak on 5-Year Outcomes After Left Atrial Appendage Closure. J Am Coll Cardiol. 2022 Aug 2;80(5):469-483. doi: 10.1016/j.jacc.2022.04.062.

    PubMed 35902169

  • Brouwer TF, Whang W, Kuroki K, Halperin JL, Reddy VY. Net Clinical Benefit of Left Atrial Appendage Closure Versus Warfarin in Patients With Atrial Fibrillation: A Pooled Analysis of the Randomized PROTECT-AF and PREVAIL Studies. J Am Heart Assoc. 2019 Dec 3;8(23):e013525. doi: 10.1161/JAHA.119.013525. Epub 2019 Nov 22.

    PubMed 31752643

  • Price MJ, Reddy VY, Valderrabano M, Halperin JL, Gibson DN, Gordon N, Huber KC, Holmes DR Jr. Bleeding Outcomes After Left Atrial Appendage Closure Compared With Long-Term Warfarin: A Pooled, Patient-Level Analysis of the WATCHMAN Randomized Trial Experience. JACC Cardiovasc Interv. 2015 Dec 28;8(15):1925-1932. doi: 10.1016/j.jcin.2015.08.035. Epub 2015 Nov 25.

    PubMed 26627989

  • Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov 19;312(19):1988-98. doi: 10.1001/jama.2014.15192.

    PubMed 25399274

  • Alli O, Doshi S, Kar S, Reddy V, Sievert H, Mullin C, Swarup V, Whisenant B, Holmes D Jr. Quality of life assessment in the randomized PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) trial of patients at risk for stroke with nonvalvular atrial fibrillation. J Am Coll Cardiol. 2013 Apr 30;61(17):1790-8. doi: 10.1016/j.jacc.2013.01.061. Epub 2013 Feb 28.

    PubMed 23500276

  • Reddy VY, Doshi SK, Sievert H, Buchbinder M, Neuzil P, Huber K, Halperin JL, Holmes D; PROTECT AF Investigators. Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation: 2.3-Year Follow-up of the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) Trial. Circulation. 2013 Feb 12;127(6):720-9. doi: 10.1161/CIRCULATIONAHA.112.114389. Epub 2013 Jan 16.

    PubMed 23325525

  • Reddy VY, Holmes D, Doshi SK, Neuzil P, Kar S. Safety of percutaneous left atrial appendage closure: results from the Watchman Left Atrial Appendage System for Embolic Protection in Patients with AF (PROTECT AF) clinical trial and the Continued Access Registry. Circulation. 2011 Feb 1;123(4):417-24. doi: 10.1161/CIRCULATIONAHA.110.976449. Epub 2011 Jan 17.

    PubMed 21242484

  • Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbinder M, Mullin CM, Sick P; PROTECT AF Investigators. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet. 2009 Aug 15;374(9689):534-42. doi: 10.1016/S0140-6736(09)61343-X.

    PubMed 19683639

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing WATCHMAN Left Atrial Appendage Closure Technology and Warfarin in people with Atrial Fibrillation and Stroke, run by Boston Scientific Corporation at 62 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, Germany, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00129545, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2015.

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