An interventional study of Tailored Strategy and Control Strategy in Ablation Techniques, Atrial Fibrillation (Paroxysmal) and Quality of Life, sponsored by Ottawa Heart Institute Research Corporation. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Ottawa Heart Institute Research Corporation · Not applicable, Interventional, and Treatment
This study looks at participants who have undergone an ablation procedure for atrial fibrillation previously, and atrial fibrillation has occurred and a second ablation procedure is needed. The study will randomize participants to either a tailored strategy for ablation or to widening the pulmonary vein isolation procedure with or without cavotricuspid isthmus ablation. The goal is to improve freedom from recurrent atrial arrhythmias at 12 months.
This is a study of patients who have undergone an ablation procedure for AF but in whom AF recurred and who are undergoing a second ablation procedure. Specifically, the investigators are interested in the group of patients whose PVs are still "isolated" during that second procedure because doctors are unsure of how best to ablate them. It is even possible that doing any more ablation in those patients is harmful.
The study will compare (1) an ablation strategy that includes commonly done ablation steps that tackle abnormalities found during the procedure (i.e., ablating "low voltage areas", searching for and ablating other arrhythmias called supraventricular tachycardias, and in some patients ablating the "posterior wall") to (2) an ablation strategy that reinforces or extends the PVI step only. In both groups, cavotricuspid isthmus ablation is also performed, if not already successfully done previously. The vanguard study will follow participants for 1 year, with a 3 year follow up planned if feasibility is met. Participants will be required to wear a Holter monitor at various timepoints and will be asked to complete atrial fibrillation and quality of life questionnaires.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 60 is below the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Ottawa Heart Institute Research Corporation is the lead sponsor of 182 studies on the registry; 42 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Homogenizing left atrium/atrial (LA) low voltage areas (LVAs), ablating inducible supraventricular tachycardia (SVTs), and if no abnormality is identified, performing empiric posterior wall isolation (PWI )followed by cavotricuspid isthmus (CTI) ablation (if successful CTI ablation not performed previously).
Procedure: Tailored Strategy
Widening wide area circumferential ablation (WACA) lines and cavotricuspid isthmus (CTI) ablation if not successfully performed previously.
Procedure: Control Strategy
Homogenizing left atrium/atrial (LA) low voltage areas (LVAs), ablating inducible supraventricular tachycardia (SVTs), and if no abnormality is identified, performing empiric posterior wall isolation (PWI )followed by cavotricuspid isthmus (CTI) ablation (if successful CTI ablation not performed previously).
Widening wide area circumferential ablation (WACA) lines and cavotricuspid isthmus (CTI) ablation if not successfully performed previously.
Freedom from recurrent atrial arrhythmia lasting >/= 30 seconds
Atrial arrhythmias include atrial fibrillation, atrial flutter, or atrial tachycardia.
Time frame: Days 57 to 365 from repeat procedure.
Procedure duration
Time, in minutes, of the repeat procedure
Time frame: From beginning of vascular access to removal of all catheters
Composite of major procedure-related complications
Procedure-related complications include embolic events, pulmonary vein stenosis, cardiac perforation, major bleeding, atrioesophageal fistula, or death)
Time frame: Baseline to 12 months
Emergency Room visits or re-hospitalizations
Visits and admissions related to recurrent atrial arrhythmias
Time frame: Baseline to 12 months
Repeat Catheter Ablation procedure
Occurrence of additional ablation after the study index procedure.
Time frame: Baseline to 12 months
Atrial Fibrillation Effect on Quality of Life
Measured by the Atrial Fibrillation Effect on Quality of Life questionnaire. Scale of 0-100, with 100 being best quality of life.
Time frame: Baseline to 12 months.
Start is estimated for Dec 2026; primary completion for Sep 2030, 45 months later.
Of 796 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 45 months is above that.
Counting every sponsor, half of 1,051 studies reached it within 33 months; a quarter within 18 and three quarters within 54.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Dec 2026, on Nov 3, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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