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Watchman FLX Pro CT Pilot Study

Primary Purpose

Non-valvular Atrial Fibrillation (AF)

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Left atrial appendage closure device WM FLX Pro
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-valvular Atrial Fibrillation (AF)

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subject is of legal age to participate in the study per the laws of their respective geography. 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 a WATCHMAN FLX Pro device. Subject is deemed suitable for the protocol-defined pharmacologic regimen. 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: Exclusion criteria are listed below. 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. Subject has eGFR <30 mL/min (chronic kidney disease stage IV or stage V). Subject is contraindicated for TEE. Subject requires long-term anticoagulation therapy for reasons other than AF-related stroke risk reduction (e.g., due to an underlying hypercoagulable state). Subject had or is planning to have any cardiac or non-cardiac intervention or surgical procedure within 30 days prior to or 60 days after implant (including, but not limited to, cardioversion, percutaneous coronary intervention, cardiac ablation, cataract surgery, etc.). Subject had a prior stroke (of any cause, whether ischemic or hemorrhagic) or TIA within the 30 days prior to enrollment. Subject had a prior major bleeding event per ISTH definitions within the 30 days prior to enrollment. 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. Subject has an active bleed. Subject has a reversible cause for AF or has transient AF. Subject has no LAA or the LAA is surgically ligated. 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 30 days prior to enrollment. Subject has a history of atrial septal repair or has an atrial septal defect/patent foramen ovale (ASD/PFO) device. Subject has a known contraindication to percutaneous catheterization procedure. Subject has a cardiac tumor. Subject has signs/symptoms of acute or chronic pericarditis. Subject has an active infection. There is evidence of tamponade physiology. Subject has New York Heart Association Class IV congestive heart failure at the time of enrollment. 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). Subject has a documented life expectancy of less than 6 months.

Sites / Locations

  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Watchman FLX Pro

Arm Description

Outcomes

Primary Outcome Measures

Device Tissue Coverage
Device surface morphology (inclusive of tissue coverage) post implant procedure as assessed over time using the serial advanced imaging modalities of cardiac computed tomography (CT) and transesophageal echocardiography (TEE) with data evaluated by an independent core laboratory.

Secondary Outcome Measures

Full Information

First Posted
September 29, 2022
Last Updated
October 18, 2023
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05567172
Brief Title
Watchman FLX Pro CT Pilot Study
Official Title
A Pilot Study to Assess WATCHMAN FLX™ Pro Implants by Cardiac Computed Tomography, Magnetic Resonance Imaging and Transesophageal Echocardiography: WATCHMAN FLX Pro CT
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 24, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
July 2024 (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
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to measure device tissue coverage post-implantation of the WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device (WATCHMAN FLX Pro) using the serial advanced imaging modalities of cardiac computed tomography (CT) and transesophageal echocardiography (TEE) and assess its relationship, if any, to clinical events.
Detailed Description
WATCHMAN FLX™ Pro CT is a prospective, single-arm, single-center, premarket investigation to assess device tissue coverage in subjects with non-valvular atrial fibrillation (AF) who receive the WATCHMAN FLX Pro device to reduce the risk of stroke. Serial advanced imaging modalities such as CT and TEE will be used. A core laboratory will independently assess select results. A subject is considered enrolled in the study when the subject or the subject's legally authorized representative signs an Informed Consent Form (ICF) approved by the Independent Ethics Committee (IEC). Up to 25 subjects in whom placement of a WATCHMAN FLX Pro device is attempted will be enrolled. A baseline assessment including TEE and/or CT imaging with optional cardiac magnetic resonance imaging (MRI) will be done within 7 days prior to the index procedure following core laboratory guidelines. Follow-up clinical assessment and imaging will occur at 14 days, 45 days, and 3 months post index procedure; only clinical assessment will be required at 12 months (unless an in-person assessment is required based on other data). Subjects who are enrolled but not implanted with a WATCHMAN FLX Pro LAAC device will be followed for safety through 12 months after the initial attempted index procedure but will not undergo imaging assessments or evaluation of biochemical markers including measures of coagulation, platelet and endothelial activation and inflammation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-valvular Atrial Fibrillation (AF)

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Watchman FLX Pro
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Left atrial appendage closure device WM FLX Pro
Intervention Description
Left atrial appendage closure
Primary Outcome Measure Information:
Title
Device Tissue Coverage
Description
Device surface morphology (inclusive of tissue coverage) post implant procedure as assessed over time using the serial advanced imaging modalities of cardiac computed tomography (CT) and transesophageal echocardiography (TEE) with data evaluated by an independent core laboratory.
Time Frame
45 days post-implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is of legal age to participate in the study per the laws of their respective geography. 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 a WATCHMAN FLX Pro device. Subject is deemed suitable for the protocol-defined pharmacologic regimen. 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: Exclusion criteria are listed below. 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. Subject has eGFR <30 mL/min (chronic kidney disease stage IV or stage V). Subject is contraindicated for TEE. Subject requires long-term anticoagulation therapy for reasons other than AF-related stroke risk reduction (e.g., due to an underlying hypercoagulable state). Subject had or is planning to have any cardiac or non-cardiac intervention or surgical procedure within 30 days prior to or 60 days after implant (including, but not limited to, cardioversion, percutaneous coronary intervention, cardiac ablation, cataract surgery, etc.). Subject had a prior stroke (of any cause, whether ischemic or hemorrhagic) or TIA within the 30 days prior to enrollment. Subject had a prior major bleeding event per ISTH definitions within the 30 days prior to enrollment. 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. Subject has an active bleed. Subject has a reversible cause for AF or has transient AF. Subject has no LAA or the LAA is surgically ligated. 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 30 days prior to enrollment. Subject has a history of atrial septal repair or has an atrial septal defect/patent foramen ovale (ASD/PFO) device. Subject has a known contraindication to percutaneous catheterization procedure. Subject has a cardiac tumor. Subject has signs/symptoms of acute or chronic pericarditis. Subject has an active infection. There is evidence of tamponade physiology. Subject has New York Heart Association Class IV congestive heart failure at the time of enrollment. 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). Subject has a documented life expectancy of less than 6 months.
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Watchman FLX Pro CT Pilot Study

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