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Randomized Controlled Trial- Ablation Strategy for Paroxysmal Atrial Fibrillation - Trigger and Substrate Guided Wide Area Radiofrequency Ablation Compared to Pulsed Field Ablation Pulmonary Vein Isolation

NCT04823299 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 556

Last updated 2026-04-29

No results posted yet for this study

Summary

Atrial fibrillation (AF) is a common heart rhythm disorder affecting over a million people in North America and is associated with serious complications including stroke, heart failure, reduced quality of life, and premature death. Catheter ablation has been shown to be more effective than medications for controlling symptoms and reducing the risk of these complications; however, recurrence of AF after ablation remains a significant challenge, often due to incomplete or ineffective initial procedures. This clinical trial aims to determine whether a novel, patient-tailored ablation strategy can improve outcomes compared to the current standard-of-care approach. Participants will be randomly assigned to undergo either standard pulmonary vein isolation or a more individualized ablation procedure that identifies and targets patient-specific sources of AF. All participants will undergo the ablation procedure, receive continuous heart rhythm monitoring, and be followed over time to assess recurrence and safety outcomes.

Conditions

Interventions

PROCEDURE

PVI-ONLY, CONTROL ARM

PULSED FIELD ABLATION (PFA) PVI-ONLY STRATEGY: CONTROL ARM

PROCEDURE

PVI-PLUS ARM, INTERVENTIONAL ARM

RADIOFREQUENCY CATHETER ABLATION (RFA) PVI-PLUS : INTERVENTION ARM

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Abbott

    collaborator INDUSTRY

  • Ottawa Heart Institute Research Corporation

    lead OTHER

Principal Investigators

  • Girish Nair, MD · Ottawa Heart Institute Research Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-23
Primary Completion
2029-03-31
Completion
2030-03-31

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04823299 on ClinicalTrials.gov