Recruiting

Ablation & Medications

Sponsor:

Nova Scotia Health Authority

Code:

NCT07272902

Conditions

Atrial Fibrillation (AF)

Heart Failure With Mildly Reduced Ejection Fraction

Heart Failure With Preserved Ejection Fraction (HFPEF)

Rate Control

Rhythm Control

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Catheter Ablation for Atrial Fibrillation

Rate Control Medications (beta-blockers, calcium channel blockers, digoxin)

Study Details

Brief summary:

This study is testing two different ways of treating atrial fibrillation (AF) in people who also have heart failure with mildly reduced or preserved heart function. Patients will randomly be assigned to either rhythm control using catheter ablation or rate control using medicines. The pilot phase will determine if a larger study can be successfully carried out to see which approach better improves survival, reduces hospitalizations, and enhances quality of life.

Conditions

Atrial Fibrillation (AF)

Heart Failure With Mildly Reduced Ejection Fraction

Heart Failure With Preserved Ejection Fraction (HFPEF)

Rate Control

Rhythm Control

Study ID

NCT07272902

Start date

Jan 1, 2026

Status verified date

Feb, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥18 years
  • Diagnosis of atrial fibrillation (documented on Holter, rhythm strip, or ECG)
  • New York Heart Association (NYHA) class II-III heart failure
  • Left ventricular ejection fraction (LVEF) >40%
  • Meet specific NT-proBNP criteria:
  • If HF hospitalization within 6 months prior to screening: NT-proBNP >200 pg/ml (if not in AF at screening) or >600 pg/ml (if in AF at screening)
  • Otherwise: NT-proBNP >300 pg/ml (if not in AF at screening) or >900 pg/ml (if in AF at screening)
  • On stable guideline-directed medical therapy for ≥1 month
  • On stable diuretic dose for ≥2 weeks
  • Suitable for either ablation-based rhythm control or rate control strategy

Exclusion Criteria:

  • Permanent atrial fibrillation diagnosis
  • Prior catheter ablation for atrial fibrillation
  • NYHA class IV heart failure
  • Rheumatic heart disease
  • Moderate or severe mitral stenosis
  • Mechanical mitral valve
  • Severe aortic stenosis or severe aortic/mitral regurgitation
  • Renal failure requiring dialysis
  • Contraindication to oral anticoagulation
  • Infiltrative cardiomyopathies
  • Complex congenital heart disease
  • Untreated thyroid disease
  • Acute coronary syndrome or coronary artery bypass surgery within 12 weeks
  • Participation in another clinical trial
  • Inability to provide informed consent
  • Other serious non-cardiovascular condition with life expectancy ≤1 year
  • Age <18 years

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Catheter Ablation (Rhythm Control Group)

Participants in this group will undergo catheter ablation procedure, scheduled within 4 weeks of joining the study.

active comparator: Medical Therapy (Rate Control Group)

Participants in this group will take medications, with the dosages adjusted over the first few weeks to find the correct dosage.

Interventions

Catheter Ablation for Atrial Fibrillation

Participants randomized to this arm will undergo catheter ablation within 4 weeks of randomization. Pulmonary vein isolation is required; additional ablation strategies may be applied at investigator discretion. Guideline-directed medical therapy for atrial fibrillation and heart failure will also be provided.

Rate Control Medications (beta-blockers, calcium channel blockers, digoxin)

Participants randomized to this arm will receive pharmacologic therapy to achieve guideline-recommended heart rate control (resting HR <80 bpm, <110 bpm with exercise). Therapy may include beta-blockers, non-dihydropyridine calcium channel blockers, or digoxin. If adequate control is not achieved with medication, AV nodal ablation and pacing may be used. Guideline-directed medical therapy for atrial fibrillation and heart failure will also be provided.

Primary outcome measure

  • Feasibility of Trial Conduct [ Time Frame: 12 months after randomization ]

Central Contacts and Locations

Central contacts

Laura Hamilton, BSC, MAHSR

902-473-7226laura.hamilton@nshealth.ca

Katie Kawulka, BScN, RN

902-473-7684katie.kawulka@nshealth.ca

Locations

QEII HSC

Recruiting

Halifax, Nova Scotia, Canada, B3H 3A7

Contacts

Laura Hamilton, BSC, MAHSR

902-473-7226laura.hamilton@nshealth.ca

Katie Kawulka, BScN, RN

902-473-7684katie.kawulka@nshealth.ca

Principal Investigator:

Ratika Parkash, MD, FRCPC

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2026-02-17.