Brief Summary
The primary objective of this clinical investigation is to demonstrate the safety and 12-month effectiveness of pulmonary vein isolation (PVI) and posterior LA wall isolation in the treatment of subjects with symptomatic paroxysmal and persistent atrial fibrillation using the pulsed field ablation with the VARIPULSE™ catheter and the TRUPULSE™ generator.
Brief Title
Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
* Symptomatic paroxysmal and persistent AF with at least one AF episode electrocardiographically documented within 24 months prior to enrollment. Electrocardiographic documentation may include, but is not limited to ECG, Transtelephonic monitoring (TTM), Zio patch monitor, telemetry strip, or consumer devices
* Age 18-80 years
* Willing and capable of providing written consent
* Able and willing to comply with all pre-, post- and follow-up testing and requirements.
Exclusion Criteria:
* Previous surgical or catheter ablation for AF
* Documented LA thrombus by imaging within 48 hours before procedure (CT, TEE, or intracardiac echocardiogram at the beginning of the procedure).
* Uncontrolled heart failure or New York Heart Association (NYHA) Class IV
* History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
* Presence of implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device that may interfere with the PFA energy field
* Women who are pregnant (as evidenced by pregnancy test if pre- menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation
* Life expectancy less than 12 months
* Currently enrolled in an investigational study evaluating another device, biologic, or drug that would interfere with this trial
* Symptomatic paroxysmal and persistent AF with at least one AF episode electrocardiographically documented within 24 months prior to enrollment. Electrocardiographic documentation may include, but is not limited to ECG, Transtelephonic monitoring (TTM), Zio patch monitor, telemetry strip, or consumer devices
* Age 18-80 years
* Willing and capable of providing written consent
* Able and willing to comply with all pre-, post- and follow-up testing and requirements.
Exclusion Criteria:
* Previous surgical or catheter ablation for AF
* Documented LA thrombus by imaging within 48 hours before procedure (CT, TEE, or intracardiac echocardiogram at the beginning of the procedure).
* Uncontrolled heart failure or New York Heart Association (NYHA) Class IV
* History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
* Presence of implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device that may interfere with the PFA energy field
* Women who are pregnant (as evidenced by pregnancy test if pre- menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation
* Life expectancy less than 12 months
* Currently enrolled in an investigational study evaluating another device, biologic, or drug that would interfere with this trial
Inclusion Criteria
Inclusion Criteria:
* Symptomatic paroxysmal and persistent AF with at least one AF episode electrocardiographically documented within 24 months prior to enrollment. Electrocardiographic documentation may include, but is not limited to ECG, Transtelephonic monitoring (TTM), Zio patch monitor, telemetry strip, or consumer devices
* Age 18-80 years
* Willing and capable of providing written consent
* Able and willing to comply with all pre-, post- and follow-up testing and requirements.
* Symptomatic paroxysmal and persistent AF with at least one AF episode electrocardiographically documented within 24 months prior to enrollment. Electrocardiographic documentation may include, but is not limited to ECG, Transtelephonic monitoring (TTM), Zio patch monitor, telemetry strip, or consumer devices
* Age 18-80 years
* Willing and capable of providing written consent
* Able and willing to comply with all pre-, post- and follow-up testing and requirements.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
80 Years
Minimum Age
18 Years
NCT Id
NCT06099730
Org Class
Other
Org Full Name
Massachusetts General Hospital
Org Study Id
2023P002605
Overall Status
Active, not recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF
Primary Outcomes
Outcome Measure
Incidence of early onset primary adverse events (PAEs)
Outcome Time Frame
within seven (7) days of an ablation procedure
Outcome Measure
Freedom from documented atrial tachyarrhythmia episodes
Outcome Time Frame
effectiveness evaluation period (Day 91-Day 365)
Outcome Measure
Freedom from acute procedural failure
Outcome Time Frame
during ablation procedure
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)
80
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