Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF (POLARIS)

Mass General Brigham

Status: Enrolling

Conditions: Atrial Fibrillation

Treatments: Device: Pulsed Field Ablation (PFA)

Study type: Interventional

Funder types: Other

Identifiers

NCT06099730

2023P002605

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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360 participants in 1 patient group

Pulsed Field Ablation

Other group

Description:

This is a non-randomized one arm study.

Treatment:

Device: Pulsed Field Ablation (PFA)