Catheter Ablation vs Medication for Atrial Fibrillation in Heart Failure

Overseen By Katie Kawulka, BScN, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Permanent AF, NYHA IV, Rheumatic heart, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two treatments for atrial fibrillation (AF), an irregular heartbeat, in individuals with heart failure. Participants will be randomly assigned to either undergo catheter ablation, a technique to restore normal heart rhythm, or take medications that control the heart's rate. The trial aims to determine which treatment improves survival, reduces hospital visits, and enhances daily living. Suitable candidates have AF and heart failure that limits some daily activities but not severely, and have been on stable heart medications for at least a month. As an unphased trial, this study provides a unique opportunity to contribute to understanding treatment options for AF and heart failure.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that catheter ablation for atrial fibrillation (AF) is generally safe. One study found early complications in only 1% of patients. However, there is a small risk of early death, affecting about 1 in 200 patients, mostly within 30 days after the procedure. Importantly, this treatment has been linked to fewer AF symptoms and hospital visits.

Medications that control heart rate for AF are also well-tolerated. Studies have shown no major safety issues when comparing different medications like metoprolol and diltiazem. These medications effectively manage heart rate in people with heart failure.

Both treatments have undergone extensive study and are considered safe options for managing AF in patients with heart failure. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for atrial fibrillation in heart failure because they offer different approaches to managing the condition. Unlike standard treatments that often rely heavily on medications to control heart rate, catheter ablation targets the source of erratic heart rhythms directly by removing or isolating problematic heart tissue. This can potentially lead to better rhythm control without the need for ongoing medication. On the other hand, the rate control medications used in this trial are tailored with adjustable dosages to optimize heart rate management, which may provide a more personalized approach to treatment. These innovative strategies could improve quality of life for patients with heart failure and atrial fibrillation by offering more effective and possibly less burdensome options.

What evidence suggests that this trial's treatments could be effective for atrial fibrillation in heart failure?

In this trial, participants will join one of two treatment groups. Research has shown that catheter ablation, which participants in the Catheter Ablation (Rhythm Control Group) will undergo, can lower death rates and reduce hospital visits for people with atrial fibrillation (AF) and heart failure. This procedure also decreases AF symptoms and heart failure issues for many patients, with most centers reporting a success rate of over 60% for those with paroxysmal AF, which is AF that comes and goes.

In contrast, participants in the Medical Therapy (Rate Control Group) will take medications to control heart rate. These medications help manage the heartbeat but don't always address the underlying AF. While both treatments aim to improve quality of life, studies have found that catheter ablation is more effective, particularly in reducing hospital stays and the risk of death. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with atrial fibrillation and heart failure who still have good or mildly reduced heart function. The study aims to find out which treatment improves survival, reduces hospital visits, and betters life quality.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either rhythm control using catheter ablation or rate control using medicines. Catheter ablation is scheduled within 4 weeks of joining the study, and medication dosages are adjusted over the first few weeks.

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of cardiovascular mortality, heart failure hospitalization, quality of life, and other health metrics.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Catheter Ablation for Atrial Fibrillation
• Rate Control Medications

Trial Overview The study compares two treatments: rhythm control through catheter ablation and rate control using medications like beta-blockers, calcium channel blockers, or digoxin. Participants will be randomly assigned to one of these approaches.

How Is the Trial Designed?

Group I: Catheter Ablation (Rhythm Control Group) Active Control 1 Intervention

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

Group II: Medical Therapy (Rate Control Group) Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Heart and Stroke Foundation of Canada

Collaborator

Trials

131

Recruited

72,600+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40778507/

Long-Term Outcomes of Catheter Ablation in Heart Failure ... Our study demonstrated that in patients with AF and HFrEF, CA was associated with significantly reduced all-cause mortality, ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.124.012926

Outcomes of Atrial Fibrillation Ablation in Heart Failure ... CA was associated with a significant reduction in AF symptoms, AF-related hospitalization, and HF symptoms in most patients irrespective of HF subtypes.

3. stopafib.org stopafib.org/procedures-for-afib/catheter-ablation/success-rates/

Atrial Fibrillation (AF) Catheter Ablation Success Rates The majority of centers reported single procedure success rates of 60% or more for paroxysmal atrial fibrillation and 30% or less for persistent atrial ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa1707855

Catheter Ablation for Atrial Fibrillation with Heart Failure Catheter ablation for atrial fibrillation in patients with heart failure was associated with a significantly lower rate of a composite end point of death.

5. nature.com nature.com/articles/s41598-025-16166-3

Meta-analysis of comprehensive prognostic evaluation in ... CA demonstrated superior benefits in improving outcomes for patients with AF and HF, including HF events, mortality, rehospitalization, AF ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11306038/

Efficacy and safety of catheter ablation for atrial fibrillation ... This meta-analysis comprehensively evaluated the efficacy and safety of CA in patients with AF and HFpEF. The results of the analysis revealed ...

7. jacc.org jacc.org/doi/10.1016/j.jacc.2019.08.1036

Risk of Mortality Following Catheter Ablation of Atrial ... Early mortality following AF ablation affected nearly 1 in 200 patients, with the majority of deaths occurring during 30-day readmission.

8. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(25)00125-0/fulltext

Safety and efficacy of catheter ablation for atrial fibrillation ... No early mortality was observed in the cohort, and the overall composite periprocedural complication rate related to ablation procedure was 1%.

9. nejm.org nejm.org/doi/full/10.1056/NEJMoa2306037

Catheter Ablation in End-Stage Heart Failure with Atrial ... Patients with heart failure and symptomatic atrial fibrillation who undergo catheter ablation have a lower likelihood of death or worsening heart failure than ...