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WATCHMAN FLX Versus NOAC for Embolic ProtectION in in the Management of Patients With Non-Valvular Atrial Fibrillation Trial
Posted by susan.d
|
WATCHMAN FLX Versus NOAC for Embolic ProtectION in in the Management of Patients With Non-Valvular Atrial Fibrillation Trial November 02, 2022 12:51PM |
Registered: 10 years ago Posts: 2,520 |
[www.medifind.com]
WATCHMAN FLX Versus NOAC for Embolic ProtectION in in the Management of Patients With Non-Valvular Atrial Fibrillation
Status: Recruiting
Closest Recruiting Location:
New York University Medical Center
New York NY, USA (18.4 mi away)
See all (154) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
The primary objective of this study is to determine if left atrial appendage closure (LAAC) with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation.
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:
Inclusion Criteria
Exclusion Criteria
• The subject is of legal age to participate in the study per the laws of their respective geography
• The subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve)
• The subject has a calculated CHA2DS2-VASc (congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, stroke or transient ischemic attack (TIA), vascular disease, age 65 to 74 years, sex category) score of 2 or greater for men and 3 or greater for women
• The subject is deemed to be suitable for the protocol-defined pharmacologic regimens in both the test and control arms
• 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
Locations
United States
Alabama
Grandview Medical Center
Recruiting
Birmingham
Contact Site
University of Alabama at Birmingham
Recruiting
Birmingham
Contact Site
Arkansas
Arrythmia Research Group
Recruiting
Jonesboro
Contact Site
Arizona
Arizona Arrhythmia Research Center
Recruiting
Phoenix
Contact Site
Phoenix Cardiovascular Research Group
Recruiting
Phoenix
Contact Site
Scottsdale Healthcare - Shea
Recruiting
Scottsdale
Contact Site
Tucson Medical Center Healthcare
Recruiting
Tucson
Contact Site
California
Colorado
Colorado Springs Cardiologist, P.C.
Recruiting
Colorado Springs
Contact Site
Connecticut
Yale University School of Medicine
Recruiting
New Haven
Contact Site
Washington, D.c.
Washington Hospital Center
Recruiting
Washington
Contact Site
Delaware
Christiana Hospital
Recruiting
Newark
Contact Site
Florida
Georgia
Emory University Hospital
Recruiting
Atlanta
Contact Site
Piedmont Hospital
Recruiting
Atlanta
Contact Site
Memorial Health University Medical Center
Recruiting
Savannah
Contact Site
Iowa
Mercy Hospital Medical Center
Recruiting
Des Moines
Contact Site
University of Iowa Hospitals and Clinics
Recruiting
Iowa City
Contact Site
Illinois
Northwestern Memorial Hospital
Recruiting
Chicago
Contact Site
Advocate Christ Medical Center
Recruiting
Oak Lawn
Contact Site
St. John's Hospital
Recruiting
Springfield
Contact Site
Indiana
Franciscan Health Indianapolis
Recruiting
Indianapolis
Contact Site
Community Hospital
Recruiting
Munster
Contact Site
Kansas
University of Kansas Hospital
Recruiting
Kansas City
Contact Site
Overland Park Regional Medical Center
Recruiting
Overland Park
Contact Site
Kentucky
Norton Hospital
Recruiting
Louisville
Contact Site
Massachusetts
Brigham and Women's Hospital
Recruiting
Boston
Contact Site
Massachusetts General Hospital
Recruiting
Boston
Contact Site
Lahey Clinic Hospital
Recruiting
Burlington
Contact Site
Charlton Memorial
Recruiting
Fall River
Contact Site
University of Massachusetts Memorial Medical Center
Recruiting
Worcester
Contact Site
Michigan
Sparrow Health System - Sparrow Hospital
Recruiting
Lansing
Contact Site
William Beaumont Hospital
Recruiting
Royal Oak
Contact Site
Minnesota
Mercy Hospital
Recruiting
Coon Rapids
Contact Site
Mayo Clinic Foundation
Recruiting
Rochester
Contact Site
Centracare Heart and Vascular Center
Recruiting
Saint Cloud
Contact Site
HealthEast St. Joseph's Hospital
Recruiting
Saint Paul
Contact Site
Missouri
St. Luke's Hospital of Kansas City
Recruiting
Kansas City
Contact Site
Mississippi
North Mississippi Medical Center
Recruiting
Tupelo
Contact Site
Montana
Billings Clinic
Recruiting
Billings
Contact Site
North Carolina
Novant Health Presbyterian Medical Center
Recruiting
Charlotte
Contact Site
Nebraska
Bergan Cardiology
Recruiting
Omaha
Contact Site
The Nebraska Medical Center
Recruiting
Omaha
Contact Site
New Hampshire
Dartmouth Hitchcock Medical Center
Recruiting
Lebanon
Contact Site
Catholic Medical Center
Recruiting
Manchester
Contact Site
New Jersey
Englewood Hospital and Medical Center
Recruiting
Englewood
Contact Site
New York
Ohio
Cleveland Clinic Foundation
Recruiting
Cleveland
Contact Site
University Hospitals of Cleveland
Recruiting
Cleveland
Contact Site
OhioHealth Research and Innovation Institute-Riverside Methodist Hospital
Recruiting
Columbus
Contact Site
Kettering Medical Center
Recruiting
Kettering
Contact Site
The Toledo Hospital
Recruiting
Toledo
Contact Site
Oregon
Legacy Emanuel Hospital & Health Center
Recruiting
Portland
Contact Site
Pennsylvania
Pinnacle Health at Harrisburg Hospital
Recruiting
Harrisburg
Contact Site
University of Pittsburgh Medical Center
Recruiting
Pittsburgh
Contact Site
York Hospital
Recruiting
York
Contact Site
South Carolina
Trident Medical Center
Recruiting
Charleston
Contact Site
Medical University of South Carolina
Recruiting
Columbia
Contact Site
Lexington Medical Center
Recruiting
West Columbia
Contact Site
Tennessee
Erlanger Medical Center
Recruiting
Chattanooga
Contact Site
Methodist Le Bonheur Healthcare
Recruiting
Germantown
Contact Site
Centennial Medical Center
Recruiting
Nashville
Contact Site
St. Thomas Health
Recruiting
Nashville
Contact Site
Vanderbilt University Medical Center
Recruiting
Nashville
Contact Site
Texas
Virginia
Inova Fairfax Hospital
Recruiting
Falls Church
Contact Site
Virginia Commonwealth University Health System
Recruiting
Richmond
Contact Site
Washington
Providence Regional Medical Center Everett
Recruiting
Everett
Contact Site
Swedish Medical Center
Recruiting
Seattle
Contact Site
CHI Franciscan Health System
Recruiting
Tacoma
Contact Site
PeaceHealth Southwest Medical
Recruiting
Vancouver
Contact Site
Wisconsin
Aurora St. Luke's Medical Center
Recruiting
Milwaukee
Contact Site
West Virginia
Monongalia General Hospital
Recruiting
Morgantown
Contact Site
Other Locations
Australia
Westmead Hospital
Recruiting
Bella Vista
Contact Site
Monash Medical Centre
Recruiting
Clayton
Contact Site
St. Vincent's Hospital-Sydney
Recruiting
Darlinghurst
Contact Site
The Alfred Hospital
Recruiting
Melbourne
Contact Site
Belgium
Onze Lieve Vrouw Ziekenhuis
Recruiting
Aalst
Contact Site
CHU de Charleroi
Recruiting
Charleroi
Contact Site
Canada
Institut universitaire de Cardiologie et de Pneumologie de Quebec
Recruiting
Québec
Contact Site
Sunnybrook Health Sciences Centre
Recruiting
Toronto
Contact Site
Denmark
Aarhus University Hospital
Recruiting
Aarhus
Contact Site
France
Germany
Israel
Shaare Zedek Medical Center
Recruiting
Jerusalem
Contact Site
Sheba Medical Center
Recruiting
Ramat Gan
Contact Site
Italy
Azienda Ospedaliera Careggi
Recruiting
Florence
Contact Site
Centro Cardiologico Monzino
Recruiting
Milano
Contact Site
Fondazione Toscana Gabriele Monasterio
Recruiting
Pisa
Contact Site
Ospedale Degli Infermi
Recruiting
Rivoli
Contact Site
Instituto Clinico Humanitas
Recruiting
Rozzano
Contact Site
Japan
Netherlands
St. Antonius Ziekenhuis
Recruiting
Nieuwegein
Contact Site
Poland
Poznan University of Medical Sciences
Recruiting
Długa
Contact Site
Saudi Arabia
King Fahed Medical City- Prince Salman Cardiac Center
Recruiting
Riyadh
Contact Site
Spain
Hospital de Leon
Recruiting
Leon
Contact Site
Hospital Clinico Salamanca
Recruiting
Salamanca
Contact Site
Hospital Álvaro Cunqueiro
Recruiting
Vigo
Contact Site
Switzerland
University Hospital Zurich
Recruiting
Zürich
Contact Site
United Kingdom
Royal Sussex County Hospital
Recruiting
Brighton
Contact Site
Glenfield Hospital
Recruiting
Leicester
Contact Site
John Radcliffe Hospital
Recruiting
Oxford
Contact S
Trial if anyone is interested.
Edited 1 time(s). Last edit at 11/02/2022 12:54PM by susan.d.
WATCHMAN FLX Versus NOAC for Embolic ProtectION in in the Management of Patients With Non-Valvular Atrial Fibrillation
Status: Recruiting
Closest Recruiting Location:
New York University Medical Center
New York NY, USA (18.4 mi away)
See all (154) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
The primary objective of this study is to determine if left atrial appendage closure (LAAC) with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation.
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:
Inclusion Criteria
Exclusion Criteria
• The subject is of legal age to participate in the study per the laws of their respective geography
• The subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve)
• The subject has a calculated CHA2DS2-VASc (congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, stroke or transient ischemic attack (TIA), vascular disease, age 65 to 74 years, sex category) score of 2 or greater for men and 3 or greater for women
• The subject is deemed to be suitable for the protocol-defined pharmacologic regimens in both the test and control arms
• 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
Locations
United States
Alabama
Grandview Medical Center
Recruiting
Birmingham
Contact Site
University of Alabama at Birmingham
Recruiting
Birmingham
Contact Site
Arkansas
Arrythmia Research Group
Recruiting
Jonesboro
Contact Site
Arizona
Arizona Arrhythmia Research Center
Recruiting
Phoenix
Contact Site
Phoenix Cardiovascular Research Group
Recruiting
Phoenix
Contact Site
Scottsdale Healthcare - Shea
Recruiting
Scottsdale
Contact Site
Tucson Medical Center Healthcare
Recruiting
Tucson
Contact Site
California
Colorado
Colorado Springs Cardiologist, P.C.
Recruiting
Colorado Springs
Contact Site
Connecticut
Yale University School of Medicine
Recruiting
New Haven
Contact Site
Washington, D.c.
Washington Hospital Center
Recruiting
Washington
Contact Site
Delaware
Christiana Hospital
Recruiting
Newark
Contact Site
Florida
Georgia
Emory University Hospital
Recruiting
Atlanta
Contact Site
Piedmont Hospital
Recruiting
Atlanta
Contact Site
Memorial Health University Medical Center
Recruiting
Savannah
Contact Site
Iowa
Mercy Hospital Medical Center
Recruiting
Des Moines
Contact Site
University of Iowa Hospitals and Clinics
Recruiting
Iowa City
Contact Site
Illinois
Northwestern Memorial Hospital
Recruiting
Chicago
Contact Site
Advocate Christ Medical Center
Recruiting
Oak Lawn
Contact Site
St. John's Hospital
Recruiting
Springfield
Contact Site
Indiana
Franciscan Health Indianapolis
Recruiting
Indianapolis
Contact Site
Community Hospital
Recruiting
Munster
Contact Site
Kansas
University of Kansas Hospital
Recruiting
Kansas City
Contact Site
Overland Park Regional Medical Center
Recruiting
Overland Park
Contact Site
Kentucky
Norton Hospital
Recruiting
Louisville
Contact Site
Massachusetts
Brigham and Women's Hospital
Recruiting
Boston
Contact Site
Massachusetts General Hospital
Recruiting
Boston
Contact Site
Lahey Clinic Hospital
Recruiting
Burlington
Contact Site
Charlton Memorial
Recruiting
Fall River
Contact Site
University of Massachusetts Memorial Medical Center
Recruiting
Worcester
Contact Site
Michigan
Sparrow Health System - Sparrow Hospital
Recruiting
Lansing
Contact Site
William Beaumont Hospital
Recruiting
Royal Oak
Contact Site
Minnesota
Mercy Hospital
Recruiting
Coon Rapids
Contact Site
Mayo Clinic Foundation
Recruiting
Rochester
Contact Site
Centracare Heart and Vascular Center
Recruiting
Saint Cloud
Contact Site
HealthEast St. Joseph's Hospital
Recruiting
Saint Paul
Contact Site
Missouri
St. Luke's Hospital of Kansas City
Recruiting
Kansas City
Contact Site
Mississippi
North Mississippi Medical Center
Recruiting
Tupelo
Contact Site
Montana
Billings Clinic
Recruiting
Billings
Contact Site
North Carolina
Novant Health Presbyterian Medical Center
Recruiting
Charlotte
Contact Site
Nebraska
Bergan Cardiology
Recruiting
Omaha
Contact Site
The Nebraska Medical Center
Recruiting
Omaha
Contact Site
New Hampshire
Dartmouth Hitchcock Medical Center
Recruiting
Lebanon
Contact Site
Catholic Medical Center
Recruiting
Manchester
Contact Site
New Jersey
Englewood Hospital and Medical Center
Recruiting
Englewood
Contact Site
New York
Ohio
Cleveland Clinic Foundation
Recruiting
Cleveland
Contact Site
University Hospitals of Cleveland
Recruiting
Cleveland
Contact Site
OhioHealth Research and Innovation Institute-Riverside Methodist Hospital
Recruiting
Columbus
Contact Site
Kettering Medical Center
Recruiting
Kettering
Contact Site
The Toledo Hospital
Recruiting
Toledo
Contact Site
Oregon
Legacy Emanuel Hospital & Health Center
Recruiting
Portland
Contact Site
Pennsylvania
Pinnacle Health at Harrisburg Hospital
Recruiting
Harrisburg
Contact Site
University of Pittsburgh Medical Center
Recruiting
Pittsburgh
Contact Site
York Hospital
Recruiting
York
Contact Site
South Carolina
Trident Medical Center
Recruiting
Charleston
Contact Site
Medical University of South Carolina
Recruiting
Columbia
Contact Site
Lexington Medical Center
Recruiting
West Columbia
Contact Site
Tennessee
Erlanger Medical Center
Recruiting
Chattanooga
Contact Site
Methodist Le Bonheur Healthcare
Recruiting
Germantown
Contact Site
Centennial Medical Center
Recruiting
Nashville
Contact Site
St. Thomas Health
Recruiting
Nashville
Contact Site
Vanderbilt University Medical Center
Recruiting
Nashville
Contact Site
Texas
Virginia
Inova Fairfax Hospital
Recruiting
Falls Church
Contact Site
Virginia Commonwealth University Health System
Recruiting
Richmond
Contact Site
Washington
Providence Regional Medical Center Everett
Recruiting
Everett
Contact Site
Swedish Medical Center
Recruiting
Seattle
Contact Site
CHI Franciscan Health System
Recruiting
Tacoma
Contact Site
PeaceHealth Southwest Medical
Recruiting
Vancouver
Contact Site
Wisconsin
Aurora St. Luke's Medical Center
Recruiting
Milwaukee
Contact Site
West Virginia
Monongalia General Hospital
Recruiting
Morgantown
Contact Site
Other Locations
Australia
Westmead Hospital
Recruiting
Bella Vista
Contact Site
Monash Medical Centre
Recruiting
Clayton
Contact Site
St. Vincent's Hospital-Sydney
Recruiting
Darlinghurst
Contact Site
The Alfred Hospital
Recruiting
Melbourne
Contact Site
Belgium
Onze Lieve Vrouw Ziekenhuis
Recruiting
Aalst
Contact Site
CHU de Charleroi
Recruiting
Charleroi
Contact Site
Canada
Institut universitaire de Cardiologie et de Pneumologie de Quebec
Recruiting
Québec
Contact Site
Sunnybrook Health Sciences Centre
Recruiting
Toronto
Contact Site
Denmark
Aarhus University Hospital
Recruiting
Aarhus
Contact Site
France
Germany
Israel
Shaare Zedek Medical Center
Recruiting
Jerusalem
Contact Site
Sheba Medical Center
Recruiting
Ramat Gan
Contact Site
Italy
Azienda Ospedaliera Careggi
Recruiting
Florence
Contact Site
Centro Cardiologico Monzino
Recruiting
Milano
Contact Site
Fondazione Toscana Gabriele Monasterio
Recruiting
Pisa
Contact Site
Ospedale Degli Infermi
Recruiting
Rivoli
Contact Site
Instituto Clinico Humanitas
Recruiting
Rozzano
Contact Site
Japan
Netherlands
St. Antonius Ziekenhuis
Recruiting
Nieuwegein
Contact Site
Poland
Poznan University of Medical Sciences
Recruiting
Długa
Contact Site
Saudi Arabia
King Fahed Medical City- Prince Salman Cardiac Center
Recruiting
Riyadh
Contact Site
Spain
Hospital de Leon
Recruiting
Leon
Contact Site
Hospital Clinico Salamanca
Recruiting
Salamanca
Contact Site
Hospital Álvaro Cunqueiro
Recruiting
Vigo
Contact Site
Switzerland
University Hospital Zurich
Recruiting
Zürich
Contact Site
United Kingdom
Royal Sussex County Hospital
Recruiting
Brighton
Contact Site
Glenfield Hospital
Recruiting
Leicester
Contact Site
John Radcliffe Hospital
Recruiting
Oxford
Contact S
Trial if anyone is interested.
Edited 1 time(s). Last edit at 11/02/2022 12:54PM by susan.d.
|
Re: WATCHMAN FLX Versus NOAC for Embolic ProtectION in in the Management of Patients With Non-Valvular Atrial Fibrillation Trial November 03, 2022 09:47AM |
Registered: 1 year ago Posts: 107 |
This would be an interesting study following patients who had a surgical occlusion vs watchman. My appendage was closed off in 2007 during a mini maze procedure. I get a wide variety of opinions from EP and Cardiologist over the years if folks like me should be on an anticoagulant. last guy I spoke with, said there is not enough data at this point to give a definitive answer. He said taking a low dose aspirin for general cardiac protection should be considered. So the jury is still out on both these closure approaches.
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