Cardiac Ablation Clinical Trials

Clinical trials related to Cardiac Ablation Procedure

AWARE-2 - 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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years on the date of consent for the trial.

• Subjects must have paroxysmal AF with at least one episode of AF over the past 12 months (patients on antiarrhythmic medications do not need to satisfy this criterion).

• At least one episode of AF documented on 12-lead ECG, Holter monitor, Trans-telephonic monitor (TTM) or Loop Recorder.

• Subjects must be able to provide informed consent.

Locations
Other Locations
Canada
McGill University Health Center
NOT_YET_RECRUITING
Montreal
University of Ottawa Heart Institute
RECRUITING
Ottawa
Contact Information
Primary
Girish Nair, MD
GNair@ottawaheart.ca
613-696-7272
Backup
Sonya Jancar
sjancar@ottawaheart.ca
613-696-7000
Time Frame
Start Date: 2026-03-23
Estimated Completion Date: 2030-03
Participants
Target number of participants: 556
Treatments
Active_comparator: PVI-ONLY ablation
Pulsed Field Ablation (PFA), control arm
Experimental: PVI-PLUS ablation
RADIOFREQUENCY CATHETER ABLATION (RFA), interventional arm
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), Abbott
Leads: Ottawa Heart Institute Research Corporation

This content was sourced from clinicaltrials.gov