Back to resultsWATCHMAN Implantation During Hybrid Ablation (WINNING)
Primary Purpose
Atrial Fibrillation, Stroke
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
WATCHMAN Device implantation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring WATCHMAN, Atrial Fibrillation, Hybrid Ablation, Safety, Feasibility, Stroke Prevention
Eligibility Criteria
Inclusion Criteria:
- Documented paroxysmal or (long-standing) persistent non-valvular atrial fibrillation,
- Eligible at least for short-term OAC therapy,
- No other conditions that would require long-term OAC therapy, suggested by current standard medical practice, and thus is eligible to stop OAC if the LAA is sealed,
- Calculated CHA2DS2-VASc score of 1 or more,
- 18 years of age or older, able and willing to provide written informed consent.
Exclusion Criteria:
- Current New York Heart Association Class IV Congestive Heart Failure,
- Current thrombocytopenia (< 100x10E9/L) or anemia (hemoglobin <6.2 mmol/L),
- Active infection or sepsis,
- Resting heart rate > 110 beats per minute,
- Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the last 30 days,
- Recent myocardial infarction (within 3 months),
- Transient case of AF (i.e., secondary to recent cardiac surgery (within 3 months)),
- Planned cardioversion 30 days post implant of the WATCHMAN Device,
- Implanted mechanical valve prosthesis,
- History of obliterated LAA,
- History of heart transplantation,
- Symptomatic carotid disease (i.e., carotid stenosis >50% associated with ipsilateral transient or visual ischemic attack evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke within 6 months),
- Necessity to use long-term OAC,
- Contraindication for use of OAC or dual anti-platelet therapy,
- Contraindication for use of aspirin,
- Pregnancy or planned pregnancy during the course of the investigation,
- Life expectancy less than 2 years,
- Participation in any other clinical study involving an investigational drug or device.
Echocardiographic Exclusion Criteria (as assessed via transthoracic echocardiography (TTE) or TEE) for this study are:
- Left ventricular ejection fraction (LVEF) < 30%,
- Intracardiac thrombus as visualized by TEE within 2 days prior to implant,
- High risk patent foramen ovale,
- Current atrial septal defect and/or previous atrial septal repair or closure device,
- Significant mitral valve stenosis (i.e., MV 4. 5 cm2),
- Existing pericardial effusion of >3 mm,
- Complex atheroma with mobile plaque of the descending aorta and/or aortic arch,
- Cardiac tumor.
Sites / Locations
- Maastricht University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
WATCHMAN Implantation
Arm Description
Outcomes
Primary Outcome Measures
Major complications during follow-up, assessed by scoring the number of complications
Device success, assessed by transesophageal echocardiogram.
Secondary Outcome Measures
Full Information
NCT ID
NCT02471131
First Posted
May 20, 2015
Last Updated
January 10, 2017
Sponsor
Maastricht University Medical Center
Collaborators
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02471131
Brief Title
WATCHMAN Implantation During Hybrid Ablation
Acronym
WINNING
Official Title
WATCHMAN LAAC Device Implantation During Hybrid Atrial Fibrillation Ablation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Atrial fibrillation (AF) is the most common cardiac arrhythmia with a lifetime risk of developing AF of 1 in 4 people aged over 40. Stroke remains the most feared complication of AF with an increase in risk by 5-fold, and is the leading cause of morbidity and mortality. The left atrial appendage (LAA) is the origin for more than 90% of the emboli in non-valvular AF. The WATCHMAN™ Left Atrial Closure Device (WATCHMAN Device, Boston Scientific) reduces the risk of stroke by closing off the LAA. During hybrid procedures for AF, LAA occlusion with epicardial devices is known to be difficult and not free of risks.It thus will be interesting to study the safety and feasibility of endocardial WATCHMAN Device implantation in a hybrid ablation approach.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Stroke
Keywords
WATCHMAN, Atrial Fibrillation, Hybrid Ablation, Safety, Feasibility, Stroke Prevention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WATCHMAN Implantation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
WATCHMAN Device implantation
Intervention Description
The implantation of the device will be done into the left atrial appendage according to the guidelines.
Primary Outcome Measure Information:
Title
Major complications during follow-up, assessed by scoring the number of complications
Time Frame
6 months
Title
Device success, assessed by transesophageal echocardiogram.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented paroxysmal or (long-standing) persistent non-valvular atrial fibrillation,
Eligible at least for short-term OAC therapy,
No other conditions that would require long-term OAC therapy, suggested by current standard medical practice, and thus is eligible to stop OAC if the LAA is sealed,
Calculated CHA2DS2-VASc score of 1 or more,
18 years of age or older, able and willing to provide written informed consent.
Exclusion Criteria:
Current New York Heart Association Class IV Congestive Heart Failure,
Current thrombocytopenia (< 100x10E9/L) or anemia (hemoglobin <6.2 mmol/L),
Active infection or sepsis,
Resting heart rate > 110 beats per minute,
Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the last 30 days,
Recent myocardial infarction (within 3 months),
Transient case of AF (i.e., secondary to recent cardiac surgery (within 3 months)),
Planned cardioversion 30 days post implant of the WATCHMAN Device,
Implanted mechanical valve prosthesis,
History of obliterated LAA,
History of heart transplantation,
Symptomatic carotid disease (i.e., carotid stenosis >50% associated with ipsilateral transient or visual ischemic attack evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke within 6 months),
Necessity to use long-term OAC,
Contraindication for use of OAC or dual anti-platelet therapy,
Contraindication for use of aspirin,
Pregnancy or planned pregnancy during the course of the investigation,
Life expectancy less than 2 years,
Participation in any other clinical study involving an investigational drug or device.
Echocardiographic Exclusion Criteria (as assessed via transthoracic echocardiography (TTE) or TEE) for this study are:
Left ventricular ejection fraction (LVEF) < 30%,
Intracardiac thrombus as visualized by TEE within 2 days prior to implant,
High risk patent foramen ovale,
Current atrial septal defect and/or previous atrial septal repair or closure device,
Significant mitral valve stenosis (i.e., MV 4. 5 cm2),
Existing pericardial effusion of >3 mm,
Complex atheroma with mobile plaque of the descending aorta and/or aortic arch,
Cardiac tumor.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Pison, MD, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229HX
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
31772531
Citation
Vroomen M, Maesen B, Luermans JG, Crijns HJ, Maessen JG, La Meir M, Pison L. Left Atrial Appendage Management with the Watchman Device during Hybrid Ablation of Atrial Fibrillation. J Interv Cardiol. 2019 Jun 26;2019:4525084. doi: 10.1155/2019/4525084. eCollection 2019.
Results Reference
derived
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WATCHMAN Implantation During Hybrid Ablation
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