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.
Brief Title
Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Atrial Fibrillation
Eligibility Criteria
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.
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.
Inclusion Criteria
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.
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.
Gender
All
Gender Based
false
Keywords
Non-valvular atrial fibrillation
Left atrial appendage
Ablation
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03795298
Org Class
Industry
Org Full Name
Boston Scientific Corporation
Org Study Id
S2239
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation
Primary Outcomes
Outcome Description
Occurrence of stroke (including ischemic and/or hemorrhagic), all cause death, and systemic embolism events adjudicated by an Independent Clinical Event Committee
Outcome Measure
Primary Effectiveness Endpoint: Stroke, All Cause Death, and Systemic Embolism
Outcome Time Frame
From randomization to 1095 days post randomization
Outcome Description
Occurrence of non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding) events adjudicated by an Independent Clinical Event Committee
Outcome Measure
Primary Safety Endpoint: Non-procedural Bleeding
Outcome Time Frame
Non-procedural events are those occurring after 3 days, calculated from implant or attempted implant date for Device patients and from date of randomization for Control patients
Secondary Outcomes
Outcome Description
Occurence of ISTH major bleeding (including procedural bleeding) events adjudicated by an Independent Clinical Event Committee
Outcome Time Frame
From randomization to 1095 days post randomization
Outcome Measure
ISTH Major Bleeding
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Luigi Dibiase
Investigator Email
ldibiase@montefiore.org
Investigator Phone
347-271-1637
Categories Mesh Debug
Heart/Cardiovascular --- ATRIAL FIBRILLATION
Heart/Cardiovascular --- ARRHYTHMIAS, CARDIAC
Brain, Spinal Cord & Nervous System --- HEART DISEASES
Heart/Cardiovascular --- HEART DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
MeSH Terms
ATRIAL FIBRILLATION
ARRHYTHMIAS, CARDIAC
HEART DISEASES
CARDIOVASCULAR DISEASES
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS