Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:10/21/2018
Start Date:February 1, 2017
End Date:December 2023
Contact:Jennifer Williams
Email:Jennifer.Williams2@bsci.com
Phone:1-800-CARDIAC

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

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.

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.

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.
We found this trial at
37
sites
1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
Principal Investigator: J. Holshouser
Phone: 704-355-4794
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Saibal Kar
Phone: 310-248-8515
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Robert Piana
Phone: 615-936-1293
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Principal Investigator: Srinivas Dukkipati
Phone: 212-824-8930
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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Aalst, 9300
Principal Investigator: Tom De Potter
Phone: 3253724449
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Principal Investigator: David Delurgio
Phone: 404-686-7992
Emory University Hospital As the largest health care system in Georgia and the only health...
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1968 Peachtree Rd NW
Atlanta, Georgia 30309
(404) 605-5000
Principal Investigator: Sandeep Goyal
Phone: 404-605-2301
Piedmont Hospital For more than a century, Piedmont Healthcare has been a recognized leader in...
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Atlanta, GA
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Baltimore, Maryland
Principal Investigator: John Wang
Phone: 443-278-9170
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3690 Grandview Parkway
Birmingham, Alabama 35243
Principal Investigator: Jose Osorio
Phone: 205-971-7578
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Charlottesville, Virginia 22908
Principal Investigator: Rohit Malhotra
Phone: 434-982-1058
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Principal Investigator: Bradley Knight
Phone: 312-926-7554
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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Dallas, Texas 75226
Principal Investigator: James Choi
Phone: 214-820-7108
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: Claudio Schuger
Phone: 313-916-9598
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Evanston, Illinois 60201
Principal Investigator: Ted Feldman
Phone: 847-570-3861
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Houston, Texas 77030
Principal Investigator: Saumya Sharma
Phone: 713-486-1625
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Jonesboro, Arkansas 72401
Principal Investigator: Devi Nair
Phone: 870-935-6729
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Kansas City, Missouri 64111
Principal Investigator: Kenneth Huber
Phone: 816-932-6248
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Lakeland, Florida
Principal Investigator: Neal Kavesh
Phone: 863-688-5842
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Lexington, Kentucky 40503
Principal Investigator: Gery Tomassoni
Phone: 859-260-6066
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Manchester, New Hampshire 03102
Principal Investigator: Jamie Kim
Phone: 603-663-6094
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Manhasset, New York 11030
Principal Investigator: Apoor Patel
Phone: 516-562-2345
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
414-649-6000
Principal Investigator: Jasbir Sra
Phone: 414-649-6853
Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
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Naperville, Illinois 60566
Principal Investigator: Moeen Saleem
Phone: 630-527-2730
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Nashville, Tennessee 37205
Principal Investigator: Robert Pickett
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600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Principal Investigator: Paul Mahoney
Phone: 757-388-1695
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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Phoenix, Arizona 85006
Principal Investigator: Ashish Pershad
Phone: 602-839-3546
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Phoenix, Arizona 85006
Principal Investigator: Vijendra Swarup
Phone: 602-456-2342
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Rochester, Minnesota 55905
Principal Investigator: David Holmes
Phone: 507-538-3429
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Rochester, New York 14621
Principal Investigator: Jeremiah Depta
Phone: 585-922-3536
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Royal Oak, Michigan 48073
Principal Investigator: Steven Almany
Phone: 248-898-8141
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Saint Paul, Minnesota 55102
Principal Investigator: Stuart Adler
Phone: 651-232-3274
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751 Medical Center Court
San Diego, California 92121
Principal Investigator: Maurice Buchbinder
Phone: 858-625-4488
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Santa Monica, California
Principal Investigator: Shephal Doshi
Phone: 310-829-7678
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Tallahassee, Florida 32308
Principal Investigator: Farhat Khairallah
Phone: 850-431-5024
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Tupelo, Mississippi 38801
Principal Investigator: James Stone Jr
Phone: 662-377-7572
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110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
Principal Investigator: Manish Shah
Phone: 202-877-7066
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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York, Pennsylvania 17315
Principal Investigator: James Harvey
Phone: 717-851-5153
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