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HEAL-LAA Clinical Trial (HEAL-LAA)

Primary Purpose

Atrial Fibrillation, Bleeding, Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WATCHMAN FLX Pro LAAC Device
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subject is of legal age to participate in the study. 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). Subject is clinically indicated for and is treated or attempted to be treated with a WATCHMAN FLX™ Pro device. Subject or legal representative is able to understand and willing to provide written informed consent to participate in the study. Subject is able and willing to return for required follow-up visits and examinations. Exclusion Criteria: Subject has a documented life expectancy of less than 6 months. Subject is currently enrolled in another investigational study, except if the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatment. Intracardiac thrombus is present. An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present. The LAA anatomy will not accommodate a Closure Device. The patient has known hypersensitivity to any portion of the device material or the individual components such that the use of the WATCHMAN FLX™ Pro Device is contraindicated. Any of the customary contraindications for other percutaneous catheterization procedure (e.g., patient size too small to accommodate transesophageal echocardiography (TEE) probe or required catheters) or conditions (e.g., active infection, bleeding disorder) are present. There are contraindications to the use of anticoagulation therapy, aspirin, or P2Y12 inhibitor. Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study (method of assessment per study physician's discretion).

Sites / Locations

  • University of Alabama Medical CenterRecruiting
  • Phoenix Cardiovascular Research GroupRecruiting
  • Tucson Medical CenterRecruiting
  • Arrhythmia Research GroupRecruiting
  • Eisenhower Medical CenterRecruiting
  • Los Robles Hospital & Medical CenterRecruiting
  • UC Health Memorial Hospital CentralRecruiting
  • Medstar Washington Hospital CenterRecruiting
  • Emory UniversityRecruiting
  • Memorial Health University Medical CenterRecruiting
  • MercyOne Iowa Heart CenterRecruiting
  • University of Kansas Health SystemRecruiting
  • Corewell HealthRecruiting
  • Kaleida Health - Gates Vascular InstituteRecruiting
  • Rochester General HospitalRecruiting
  • Novant Health Heart & Vascular InstituteRecruiting
  • Cleveland ClinicRecruiting
  • Erlanger Health, Inc.,Recruiting
  • Centennial Medical CenterRecruiting
  • Texas Cardiac Arrhythmia ResearchRecruiting
  • Memorial Hermann Memorial City Medical CenterRecruiting
  • Christus Trinity Mother FrancesRecruiting
  • St. Mark's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Device Group

Arm Description

WATCHMAN FLX Pro LAAC Device Implantation

Outcomes

Primary Outcome Measures

The rate of leak (>5 mm) for the WATCHMAN FLX™ Pro Primary Analysis Subset is less than the rate of leak (> 5mm) of the performance goal.
Primary Analysis will be conducted on the initial 500 enrolled subjects which make up the Primary Analysis Subset.
The composite rate of all-cause mortality, all stroke, systemic embolism, and major bleeding for the WATCHMAN FLX™ Pro Primary Analysis Subset is less than a performance goal.
Primary Analysis will be conducted on the initial 500 enrolled subjects which make up the Primary Analysis Subset.

Secondary Outcome Measures

Full Information

First Posted
March 30, 2023
Last Updated
October 20, 2023
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05809596
Brief Title
HEAL-LAA Clinical Trial
Acronym
HEAL-LAA
Official Title
HEAL-LAA: Post-Market Real World Outcomes in WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2023 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to collect real-world data on WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device in patients with non-valvular atrial fibrillation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Bleeding, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Device Group
Arm Type
Other
Arm Description
WATCHMAN FLX Pro LAAC Device Implantation
Intervention Type
Device
Intervention Name(s)
WATCHMAN FLX Pro LAAC Device
Other Intervention Name(s)
Left Atrial Appendage Closure
Intervention Description
Treatment with a WATCHMAN FLX Pro Left Atrial Appendage Closure Device
Primary Outcome Measure Information:
Title
The rate of leak (>5 mm) for the WATCHMAN FLX™ Pro Primary Analysis Subset is less than the rate of leak (> 5mm) of the performance goal.
Description
Primary Analysis will be conducted on the initial 500 enrolled subjects which make up the Primary Analysis Subset.
Time Frame
45 days
Title
The composite rate of all-cause mortality, all stroke, systemic embolism, and major bleeding for the WATCHMAN FLX™ Pro Primary Analysis Subset is less than a performance goal.
Description
Primary Analysis will be conducted on the initial 500 enrolled subjects which make up the Primary Analysis Subset.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is of legal age to participate in the study. 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). Subject is clinically indicated for and is treated or attempted to be treated with a WATCHMAN FLX™ Pro device. Subject or legal representative is able to understand and willing to provide written informed consent to participate in the study. Subject is able and willing to return for required follow-up visits and examinations. Exclusion Criteria: Subject has a documented life expectancy of less than 6 months. Subject is currently enrolled in another investigational study, except if the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatment. Intracardiac thrombus is present. An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present. The LAA anatomy will not accommodate a Closure Device. The patient has known hypersensitivity to any portion of the device material or the individual components such that the use of the WATCHMAN FLX™ Pro Device is contraindicated. Any of the customary contraindications for other percutaneous catheterization procedure (e.g., patient size too small to accommodate transesophageal echocardiography (TEE) probe or required catheters) or conditions (e.g., active infection, bleeding disorder) are present. There are contraindications to the use of anticoagulation therapy, aspirin, or P2Y12 inhibitor. Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study (method of assessment per study physician's discretion).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Schutt
Phone
1-800-CARDIAC
Email
angela.schutt@bsci.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Kanj, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Oluseun Alli, MD
Organizational Affiliation
Novant Health Heart & Vascular Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugh McElderry, MD
Facility Name
Phoenix Cardiovascular Research Group
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashish Sadhu, MD
Facility Name
Tucson Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Waggoner, DO
Facility Name
Arrhythmia Research Group
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Devi Nair, MD
Facility Name
Eisenhower Medical Center
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leon Feldman, MD
Facility Name
Los Robles Hospital & Medical Center
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saibal Kar, MD
Facility Name
UC Health Memorial Hospital Central
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brad Mikaelian, MD
Facility Name
Medstar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manish Shah, MD
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David DeLurgio, MD
Facility Name
Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Newton, MD
Facility Name
MercyOne Iowa Heart Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Troy Hounshell, DO
Facility Name
University of Kansas Health System
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madhu Reddy, MD
Facility Name
Corewell Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajinder Marok, MD
Facility Name
Kaleida Health - Gates Vascular Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vijay Iyer, MD
Facility Name
Rochester General Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremiah Depta, MD
Facility Name
Novant Health Heart & Vascular Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oluseun Alli, MD
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Kanj, MD
Facility Name
Erlanger Health, Inc.,
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Coylewright, MD, MPH
Facility Name
Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Goodman, MD
Facility Name
Texas Cardiac Arrhythmia Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Natale, MD
Facility Name
Memorial Hermann Memorial City Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77094
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amir Kashani, MD
Facility Name
Christus Trinity Mother Frances
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stanislav Weiner, MD
Facility Name
St. Mark's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vamsee Yaganti, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing URL
http://www.bostonscientific.com/content/gwc/en-US/data-sharing-requests.html

Learn more about this trial

HEAL-LAA Clinical Trial

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