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OPTION: Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation

Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03795298
Collaborator
(none)
1,600
Enrollment
116
Locations
2
Arms
65.4
Anticipated Duration (Months)
13.8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high risk patients with non-valvular atrial fibrillation.

Condition or Disease Intervention/Treatment Phase
  • Device: WATCHMAN FLX Implant
  • Drug: Market-approved OAC
 N/A

Detailed Description

This study is a prospective, randomized, multi-center, global investigation to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation in patients after AF ablation.

A subject who signs informed consent is considered enrolled in the study. Subjects will be randomized to OAC or WATCHMAN FLX in equal fashion. Randomization will be stratified by sequential vs. concomitant planned ablation +/- WATCHMAN implantation, to help ensure balance of treatment assignments within the sequential and concomitant groups.

Study Design

Study Type:
Interventional
Actual Enrollment :
1600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation
Actual Study Start Date :
May 20, 2019
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: WATCHMAN FLX

WATCHMAN FLX implant including modified post-implant drug regimen.

Device: WATCHMAN FLX Implant
Left atrial appendage closure with the WATCHMAN FLX device
Active Comparator: Market-approved OAC

Used per IFU for atrial fibrillation stroke prevention for the duration of the trial.

Drug: Market-approved OAC
Used per IFU for atrial fibrillation stroke prevention for the duration of the trial.

Outcome Measures

Primary Outcome Measures

  1. Stroke, all cause death, and systemic embolism [36 months]

    WATCHMAN therapy is non-inferior for the occurrence of stroke (including ischemic and/or hemorrhagic), all cause death, and systemic embolism.

  2. Non-procedural bleeding [36 months]

    WATCHMAN therapy is superior for non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding).

Secondary Outcome Measures

  1. Major bleeding [36 months]

    WATCHMAN therapy is non-inferior for ISTH major bleeding (including procedural bleeding).

Eligibility Criteria

Criteria

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

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

  2. Underwent a prior catheter ablation procedure for non-valvular AF between 90 and 180 days prior to randomization (sequential) or is planning to have clinically indicated catheter ablation within 10 days of randomization (concomitant).

  3. The subject has a calculated CHA2DS2-VASc score of 2 or greater for males or 3 or greater for females.

  4. The subject is deemed to be suitable for the defined protocol pharmacologic regimen.

  5. The subject is able to undergo TEE examinations.

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

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

Exclusion Criteria:

  1. The subject is currently enrolled in another investigational study 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 must be brought to the attention of the sponsor to determine eligibility, regardless of type of co-enrollment being proposed.

  2. The subject requires long-term anticoagulation therapy for reasons other than AF-related stroke risk reduction, for example due to an underlying hypercoagulable state (i.e., even if the device is implanted, the subjects would not be eligible to discontinue OAC due to other medical conditions requiring chronic OAC therapy).

  3. The subject is deemed by the treating physician to be unsuitable for chronic anticoagulation and/or aspirin therapy due to bleeding risk, allergy, or other reasons.

  4. The subject had or is planning to have any cardiac or major non-cardiac interventional or surgical procedure (excluding non-valvular AF ablation and cardioversion) within 30 days prior to or 60 days after randomization [including, but not limited to: percutaneous coronary intervention (PCI), other cardiac ablation (VT ablation, etc.), etc.].

  5. The subject had a stroke or transient ischemic attack (TIA) within the 60 days prior to randomization.

  6. The subject had a prior major bleeding event per ISTH definition 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.

  7. The subject has had a myocardial infarction (MI) documented in the clinical record as either a non-ST elevation MI (NSTEMI) or as an ST-elevation MI (STEMI), with or without intervention, within 90 days prior to randomization.

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

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

  10. 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)

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

  12. The subject has a cardiac tumor.

  13. The subject has signs/symptoms of acute or chronic pericarditis.

  14. There is evidence of tamponade physiology.

  15. Contraindications (anatomical or medical) to percutaneous catheterization procedures.

  16. The subject has documented NYHA Class IV heart failure.

  17. The subject has documented surgical closure of the left atrial appendage.

  18. The subject has an active infection.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Grandview Medical Center Birmingham Alabama United States 35243
2 Heart Center Research Huntsville Alabama United States 35801
3 Alaska Regional Hospital Anchorage Alaska United States 99508
4 Arizona Arrhythmia Research Center Phoenix Arizona United States 85016
5 Phoenix Cardiovascular Research Group Phoenix Arizona United States 85016
6 St. Bernard's Medical Center Jonesboro Arkansas United States 72401
7 Heart Clinic Arkansas Little Rock Arkansas United States 72205
8 Mills Peninsula Health Services Burlingame California United States 94010
9 Scripps Memorial Hospital La Jolla California United States 92037
10 Marin General Hospital Larkspur California United States 94939
11 University of Southern California Hospital Los Angeles California United States 90017
12 Sharp Memorial Hospital San Diego California United States 92123
13 Kaiser Permanente Santa Clara Medical Center Santa Clara California United States 95051
14 Marian Regional Medical Center Santa Maria California United States 93454
15 Los Robles Hospital & Medical Center Thousand Oaks California United States 91360
16 Memorial Hospital Colorado Springs Colorado United States 80909
17 Centura Health Littleton Colorado United States 80120
18 Medical Center of the Rockies (Loveland) Loveland Colorado United States 80538
19 Yale University School of Medicine New Haven Connecticut United States 06510
20 Washington Hospital Center Washington District of Columbia United States 20010
21 Manatee Memorial Hospital Bradenton Florida United States 34205
22 Broward General Medical Center Fort Lauderdale Florida United States 33316
23 St. Vincent's Medical Center Jacksonville Florida United States 32204
24 AdventHealth Ocala Ocala Florida United States 34471
25 Tallahassee Memorial Hospital Tallahassee Florida United States 32308
26 Emory University Hospital Atlanta Georgia United States 30322
27 Wellstar Kennestone Hospital Marietta Georgia United States 30060
28 St. Alphonsus Regional Medical Center Boise Idaho United States 83704
29 St. Lukes Idaho Cardiology Associates Boise Idaho United States 83712
30 Edward Hospital Naperville Illinois United States 60540
31 St. John's Hospital Springfield Illinois United States 62701
32 Methodist Hospital of Indianapolis Indianapolis Indiana United States 46202
33 St. Vincent Heart Center of Indiana Indianapolis Indiana United States 46290
34 Iowa Heart Center Des Moines Iowa United States 50266
35 Overland Park Regional Medical Center Kansas City Kansas United States 66160
36 University of Kansas Hospital Kansas City Kansas United States 66160
37 Kansas City Cardiac Arrhythmia Research Overland Park Kansas United States 66215
38 Baptist Health Lexington Lexington Kentucky United States 40503
39 Massachusetts General Hospital Boston Massachusetts United States 02114
40 Lahey Clinic Hospital Burlington Massachusetts United States 01805
41 Henry Ford Hospital Detroit Michigan United States 48202
42 Mid Michigan Medical Center Midland Michigan United States 48670
43 Abbott Northwestern Hospital Minneapolis Minnesota United States 55407
44 Mayo Clinic Rochester Minnesota United States 55905
45 HealthEast St. Joseph's Hospital Saint Paul Minnesota United States 55102
46 St. Luke's Hospital of Kansas City Kansas City Missouri United States 64111
47 Mercy Research Saint Louis Missouri United States 63141
48 Nebraska Heart Institute Lincoln Nebraska United States 68526
49 Catholic Medical Center Manchester New Hampshire United States 03102
50 Cardiovascular Associates of the Delaware Valley Haddon Heights New Jersey United States 08035
51 Valley Hospital Ridgewood New Jersey United States 07450
52 Northwell Health Bay Shore New York United States 11706
53 Montefiore Medical Center Bronx New York United States 10467
54 New York University Medical Center New York New York United States 10016
55 Mount Sinai Medical Center New York New York United States 10029
56 Carolinas Medical Center Charlotte North Carolina United States 28203
57 Duke University Medical Center Durham North Carolina United States 27705
58 Rex Hospital Raleigh North Carolina United States 27607
59 Lindner Center for Research and Education at Christ Hospital Cincinnati Ohio United States 45219
60 Cleveland Clinic Foundation Cleveland Ohio United States 44195
61 OhioHealth Research and Innovation Institute - Riverside Methodist Hospital Columbus Ohio United States 43214
62 Pinnacle Health at Harrisburg Hospital Harrisburg Pennsylvania United States 17101
63 Presbyterian University of Pennsylvania Medical Center Philadelphia Pennsylvania United States 19104
64 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15237
65 Lankenau Institute for Medical Research Wynnewood Pennsylvania United States 19096
66 York Hospital York Pennsylvania United States 17403
67 Centennial Medical Center Nashville Tennessee United States 37203
68 Saint Thomas Health Nashville Tennessee United States 37205
69 Vanderbilt University Medical Center Nashville Tennessee United States 37232
70 Texas Cardiac Arrhythmia Research Austin Texas United States 78705
71 HeartPlace Mid-Cities EP Bedford Texas United States 76021
72 The Heart Hospital Baylor Plano Plano Texas United States 75093
73 Cardiology Clinic of San Antonio San Antonio Texas United States 78229
74 Christus Trinity Mother Frances Health System Tyler Texas United States 75702
75 St. Mark's Hospital Salt Lake City Utah United States 84124
76 Chippenham Medical Center Richmond Virginia United States 23225
77 CHI Franciscan Health System Tacoma Washington United States 98405
78 PeaceHealth Southwest Medical Vancouver Washington United States 98664
79 Monongalia General Hospital Morgantown West Virginia United States 26506
80 West Virginia University Hospitals Morgantown West Virginia United States 26506
81 Heart Care Partners Brisbane Queensland Australia 4120 QLD
82 Monash Medical Centre Clayton Victoria Australia 3168
83 Onze Lieve Vrouw Ziekenhuis Aalst East Flanders Belgium 9300
84 Aarhus University Hospital Aarhus Denmark 8200
85 CHRU de Lille Lille Hauts-de-France France 59037
86 Hospital de la Pitie-Salpetriere Paris Ile-de-France France 75013
87 CHRU de Clermont-Ferrand Clermont-Ferrand France 63000
88 CHU Grenoble - Hopital Michallon Grenoble France 38043
89 Hospital Europeen Georges-Pompidou Paris France 75015
90 Clinique Pasteur Toulouse France 31076
91 Centre Hôpital Universitaire Rangueil Toulouse France 31400
92 CHU Henri Mondor Créteil Île-de-France France 94010
93 Charite, Campus Benjamin Franklin Berlin Germany 12203
94 University Berlin, Charite Virchow Standort, Wedding Berlin Germany 13353
95 Klinikum Coburg GmbH Coburg Germany 96450
96 St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH Erfurt Germany 99097
97 Cardioangiologisches Centrum Bethanien Frankfurt Germany 60431
98 Universitatsklinik Greifswald Greifswald Germany 17475
99 Asklepios Klinik Saint Georg Hamburg Germany 20099
100 Allgemeines Krankenhaus Altona Hamburg Germany 22763
101 Klinikum St. Georg Leipzig Germany 4129
102 Universitaetsklinikum Schleswig-Holstein Lübeck Germany D-23538
103 St. Josefs-Hospital GmbH Wiesbaden Germany 65189
104 Centro Cardiologico Monzino Milano Italy 20138
105 Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino Torino Italy 10123
106 St. Antonius Ziekenhuis Nieuwegein Utrecht Netherlands 3430 EM
107 Gornoslaskie Centrum Medyczne im. Prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach Ziolow Katowice Poland 40635
108 Poznan University of Medical Sciences Poznan Poland 61-848
109 Slaskie Centrum Chorob Serca Zabrze Poland 41800
110 Hospital General Universitario Alicante Spain 3010
111 Hospital Puerta Del Mar Cadiz Spain 11009
112 Hospital Clinico San Carlos Madrid Spain 28040
113 Clinica Universidad de Navarra Pamplona Spain 31008
114 Hospital Clinico Salamanca Salamanca Spain 37007
115 Clinico de Valladolid Valladolid Spain 47005
116 Hospital Alvaro Cunqueiro Vigo Spain 36312

Sponsors and Collaborators

  • Boston Scientific Corporation

Investigators

  • Principal Investigator: Oussama Wazni, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT03795298
Other Study ID Numbers:
  • S2239
First Posted:
Jan 7, 2019
Last Update Posted:
Jul 29, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Ablation
Additional relevant MeSH terms:
Atrial Fibrillation

Study Results

No Results Posted as of Jul 29, 2022