Clinical trial NCT06099730: Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF
Official title: Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of early onset primary adverse events (PAEs)
timeFrame: within seven (7) days of an ablation procedure
measure: Freedom from documented atrial tachyarrhythmia episodes
timeFrame: effectiveness evaluation period (Day 91-Day 365)
measure: Freedom from acute procedural failure
timeFrame: during ablation procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: St. Bernard's Heart and Vascular Center
state: Arkansas
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Montefiore Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Institute/Research Foundation
state: Texas
Study officials:
References: