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ASAP-TOO: Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation

Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02928497
Collaborator
(none)
481
Enrollment
92
Locations
2
Arms
105.8
Anticipated Duration (Months)
5.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to establish the safety and effectiveness of the WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device, including the post-implant medication regimen, for subjects with non-valvular atrial fibrillation who are deemed not to be eligible for anti-coagulation therapy to reduce the risk of stroke.

Condition or Disease Intervention/Treatment Phase
  • Device: WATCHMAN LAAC Device Implant
  • Drug: Single Antiplatelet Therapy or No Therapy (Control)
 N/A

Detailed Description

The ASAP-TOO study is a prospective, randomized, multi-center, global investigation to establish the safety and effectiveness of the WATCHMAN Device for subjects with non-valvular atrial fibrillation who are deemed not suitable for anti-coagulation therapy to reduce the risk of stroke.

Subjects will be randomized in a ratio of 2 Device to 1 Control to receive the WATCHMAN LAA closure device (Device) or the control treatment of single antiplatelet medication or no medication at the discretion of the study physician (Control). All randomized subjects will follow the protocol required tests and assessments at each scheduled follow-up visit.

Study Design

Study Type:
Interventional
Actual Enrollment :
481 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation (ASAP-TOO)
Actual Study Start Date :
Feb 6, 2017
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: WATCHMAN (Device)

WATCHMAN LAAC Device implant including modified post-implant drug regimen.

Device: WATCHMAN LAAC Device Implant
WATCHMAN LAAC Implant
Active Comparator: Control

Single antiplatelet therapy or no therapy (Control) at the discretion of the study physician for the duration of the trial.

Drug: Single Antiplatelet Therapy or No Therapy (Control)
Single Antiplatelet Therapy or No Therapy at the discretion of the study physician.

Outcome Measures

Primary Outcome Measures

  1. Primary 7-Day Device/Procedural Safety Endpoint [7 days]

    The primary safety endpoint is the 7-day combined rate of death, ischemic stroke, systemic embolism and complications requiring major cardiovascular or endovascular intervention.

  2. Primary Efficacy Endpoint - time to first event of ischemic stroke or systemic embolism. [5 years]

    The primary efficacy endpoint is the comparison of time to first event of ischemic stroke and systemic embolism.

Secondary Outcome Measures

  1. Secondary Endpoint - Composite of All Stroke and Cardiovascular or Unknown Death [5 years]

    The occurrence of stroke (including ischemic and/or hemorrhagic), cardiovascular death (cardiovascular and/or unexplained cause) and systemic embolism

  2. Secondary Endpoint - Major Bleeding [5 years]

    The occurrence of major bleeding (defined as a BARC Type 3 or 5 event)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • The subject is of legal age to participate in the study per the laws of their respective geography.

  • The subject has documented paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular atrial fibrillation (i.e., the subject has not been diagnosed with rheumatic mitral valvular heart disease).

  • The subject has a calculated CHA2DS2-VASc score of 2 or greater.

  • The subject is deemed by two study physicians to be unsuitable for oral anticoagulation.

  • The subject is deemed by a study physician to be suitable for the defined protocol pharmacologic regimen of aspirin and clopidogrel therapy following WATCHMAN Closure Device implant.

  • The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial.

  • The subject is able and willing to return for required follow-up visits and examinations.

Exclusion Criteria:

  • The subject is unable or unwilling to return for required follow-up visits and examinations.

  • The subject had or is planning to have any invasive cardiac procedure within 30 days prior to randomization (e.g., cardioversion, ablation).

  • The subject is planning to have any cardiac or non-cardiac invasive or surgical procedure that would necessitate stopping or modifying the protocol required medication regimen within 90 days after the WATCHMAN Closure Device implant (e.g., cardioversion, ablation, cataract surgery).

  • The subject had a prior stroke (of any cause) or TIA within the 30 days prior to randomization.

  • The subject had a prior BARC type 3 or 4 bleeding event within the 14 days prior to randomization. Lack of resolution of related clinical sequelae, or planned and pending interventions to resolve bleeding/bleeding source, are a further exclusion regardless of timing of the bleeding event.

  • The subject has a history of atrial septal repair or has an ASD/PFO device.

  • The subject has an implanted mechanical valve prosthesis in any position.

  • The subject suffers from New York Heart Association Class IV Congestive Heart Failure.

  • The subject has LVEF < 30%.

  • The subject is of childbearing potential and is, or plans to become pregnant during the time of the study (method of assessment upon study physician's discretion).

  • The subject is currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.

  • The subject has a life expectancy of less than two years.

  • The subject has a known or suspected hypercoagulable state.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Grandview Medical Center Birmingham Alabama United States 35243
2 Huntsville Hospital Huntsville Alabama United States 35801
3 Arizona Arrhythmia Research Center Phoenix Arizona United States 85016
4 Arrhythmia Research Group Jonesboro Arkansas United States 72401
5 Scripps Memorial Hospital La Jolla California United States 10666
6 Cedars - Sinai Medical Center Los Angeles California United States 90048
7 Sharpe Chula Vista Medical Center San Diego California United States 92121
8 Santa Barbara Cottage Hospital Santa Barbara California United States 93102
9 St. John's Health Center Santa Monica California United States 90404
10 North Colorado Medical Center Greeley Colorado United States 80631
11 St. Anthony Hospital Lakewood Colorado United States 80228
12 Washington Hospital Center Washington District of Columbia United States 20010
13 Delray Medical Center Delray Beach Florida United States 33484
14 Lakeland Regional Medical Center Lakeland Florida United States 33805
15 Sarasota Memorial Hospital Sarasota Florida United States 34239
16 Tallahassee Memorial Hospital Tallahassee Florida United States 32308
17 Bay Area Cardiology Associates Tampa Florida United States 33511
18 Tampa General Hospital Tampa Florida United States 33606
19 Emory University Hospital Atlanta Georgia United States 30308
20 Northwestern Memorial Hospital Chicago Illinois United States 60611
21 NorthShore University Health System Evanston Illinois United States 60201
22 Edward Hospital Naperville Illinois United States 60540
23 Advocate Christ Medical Center Oak Lawn Illinois United States 60453
24 St. John's Hospital Springfield Illinois United States 62769
25 St. Vincent's Hospital Indianapolis Indiana United States 46290
26 Heart Group at Deaconness Hospital Newburgh Indiana United States 47630
27 Mercy Hospital Medical Center West Des Moines Iowa United States 50266
28 Kansas City Cardiac Arrhythmia Research Overland Park Kansas United States 66211
29 Baptist Health Lexington Lexington Kentucky United States 40503
30 Maine Medical Center Portland Maine United States 04074
31 Union Memorial Hospital Baltimore Maryland United States 21218
32 Soutcoast Physicians Group Fall River Massachusetts United States 02720
33 Henry Ford Hospital Detroit Michigan United States 48202
34 Mayo Clinic Foundation Rochester Minnesota United States 55905
35 Centracare Heart and Vascular Saint Cloud Minnesota United States 56303
36 HealthEast St. Joseph's Hospital Saint Paul Minnesota United States 55102
37 North Mississippi Medical Center Tupelo Mississippi United States 38801
38 St. Luke's Hospital of Kansas City Kansas City Missouri United States 64111
39 Mercy Research Saint Louis Missouri United States 63141
40 Billings Clinic Billings Montana United States 59101
41 The Nebraska Medical Center Omaha Nebraska United States 68198
42 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
43 Catholic Medical Center Manchester New Hampshire United States 03102
44 Cardiovascular Associates of the Delaware Valley Haddon Heights New Jersey United States 08035
45 St. Barnabas Medical Center Newark New Jersey United States 07112
46 The Valley Hospital Ridgewood New Jersey United States 07450
47 Mount Sinai Medical Center New York New York United States 10029
48 Rochester General Hospital Rochester New York United States 14621
49 Northwell Health Staten Island New York United States 10305
50 Carolinas Medical Center Charlotte North Carolina United States 28203
51 Summa Health System Akron Ohio United States 44304
52 Aultman Hospital Canton Ohio United States 44710
53 Ohio State University Medical Center Columbus Ohio United States 43210
54 OhioHealth Research and Innovation Institute - Riverside Methodist Hospital Columbus Ohio United States 43214
55 Oklahoma Heart Institute Tulsa Oklahoma United States 74104
56 Oregon Health Sciences University Portland Oregon United States 97239
57 Lehigh Valley Hospital Allentown Pennsylvania United States 18103
58 Pinnacle Health at Harrisburg Hospital Harrisburg Pennsylvania United States 17043
59 Penn State Milton S Hershey Medical Center Hershey Pennsylvania United States 17033
60 York Hospital York Pennsylvania United States 17403
61 Saint Thomas Health Nashville Tennessee United States 37205
62 Baylor Heart and Vascular Hospital Dallas Texas United States 75226
63 University of Texas Houston Health Science Center The Woodlands Texas United States 77384
64 University of Virginia Medical Center Charlottesville Virginia United States 22908
65 Inova Fairfax Hospital Falls Church Virginia United States 22042
66 Carilion Roanoke Memorial Hospital Roanoke Virginia United States 24014
67 CHI Franciscan Health System Tacoma Washington United States 98405
68 PeaceHealth Southwest Medical Vancouver Washington United States 98664
69 Aurora St. Luke's Medical Center Milwaukee Wisconsin United States 53215
70 Froedtert Memorial Lutheran Hospital Milwaukee Wisconsin United States 53215
71 Aspirus Heart and Vascular Institute - Research and Education Wausau Wisconsin United States 54401
72 Onze Lieve Vrouw Ziekenhuis Aalst Belgium 9300
73 ZNA Middelheim Antwerp Belgium
74 Ottawa Heart Institute Ottawa Canada
75 Institut universitaire de Cardiologie et de Pneumologie de Quebec Ste-foy Canada
76 Vancouver General Hospital Vancouver Canada
77 Na Homolce Hospital Prague Czechia 150 30
78 Skejby Sygehus Aarhus N Denmark DK-8200
79 Rigshospitalet Copenhagen Copenhagen Denmark 2100
80 Universitaetsklinikum Dusseldorf Dusseldorf Germany
81 St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH Erfurt Germany
82 Cardioangiologisches Centrum Bethanien Frankfurt Germany
83 Cardiologicum Hamburg Praxis Wandsbek Hamburg Germany
84 Herzzentrum Universität Leipzig Leipzig Germany
85 Fondazione Toscana Gabriele Monasterio Massa Italy
86 Medisch Spectrum Twente Enschede Netherlands
87 St. Antonius Ziekenhuis Nieuwegein Netherlands
88 Royal Victoria Hospital Belfast United Kingdom
89 Royal Sussex County Hospital Brighton United Kingdom
90 Guys and St. Thomas NHS Foundation Trust London United Kingdom
91 The Brompton Hospital London United Kingdom
92 John Radcliffe Hospital Oxford United Kingdom

Sponsors and Collaborators

  • Boston Scientific Corporation

Investigators

  • Principal Investigator: Jacqueline Saw, MD, Vancouver General Hospital
  • Principal Investigator: Vivek Reddy, MD, Icahn School of Medicine at Mount Sinai
  • Principal Investigator: Maurice Buchbinder, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT02928497
Other Study ID Numbers:
  • S2317
First Posted:
Oct 10, 2016
Last Update Posted:
Jul 29, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Boston Scientific Corporation
Non-valvular atrial fibrillation
Left atrial appendage

Study Results

No Results Posted as of Jul 29, 2022