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

Atrial Fibrillation Clinical Trial

— POLARIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06099730
• Other study ID #: 2023P002605
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2023
• Est. completion date: November 2024

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Pulsed Field Ablation (PFA)
PFA using Irreversible Electroporation (IRE) Ablation System

Locations

Country	Name	City	State
United States	Texas Cardiac Arrhythmia Institute/Research Foundation	Austin	Texas
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Mount Sinai Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of early onset primary adverse events (PAEs)		within seven (7) days of an ablation procedure
Primary	Freedom from documented atrial tachyarrhythmia episodes		effectiveness evaluation period (Day 91-Day 365)
Primary	Freedom from acute procedural failure		during ablation procedure