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NCT Number: NCT06099730

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Bernard's Heart and Vascular Center, Jonesboro, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulsed Field Ablation (PFA)

Device

PFA using Irreversible Electroporation (IRE) Ablation System

Primary outcomes

  1. Incidence of early onset primary adverse events (PAEs)

    Time frame: within seven (7) days of an ablation procedure

  2. Freedom from documented atrial tachyarrhythmia episodes

    Time frame: effectiveness evaluation period (Day 91-Day 365)

  3. Freedom from acute procedural failure

    Time frame: during ablation procedure

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Acronym: POLARIS

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Oct 25, 2023
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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