Catheter Ablation for Atrial Fibrillation
(CRAAFT-HF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether catheter ablation, a procedure that corrects irregular heartbeats, is more effective than medication alone for individuals with atrial fibrillation (AF) and heart failure. The main goal is to determine if this procedure can reduce unplanned hospital visits and enhance quality of life. Participants should have experienced irregular heartbeats lasting more than six hours but less than three years, and have heart failure impacting daily activities. As an unphased trial, this study provides participants the chance to contribute to valuable research that could enhance treatment options for AF and heart failure.
What prior data suggests that catheter ablation is safe for atrial fibrillation patients?
Research has shown that catheter ablation is generally safe for treating atrial fibrillation (AF). A large U.S. study examined nearly 94,000 procedures and found complications in 6.29% of cases. Serious complications were even less common, occurring in just 2.4% of cases. Problems involving blood vessels affected 1.3% of patients. Deaths related to the procedure were extremely rare, at only 0.05%.
Although no medical procedure is without risk, these findings suggest that catheter ablation is generally well-tolerated. Most complications are not severe, and the risk of serious problems is low.12345Why are researchers excited about this trial?
Catheter ablation is unique because it directly targets and eliminates the abnormal electrical pathways in the heart that cause atrial fibrillation (AF), aiming to restore a normal heart rhythm. Unlike standard treatments for AF, which often include medications like beta-blockers or antiarrhythmic drugs that manage symptoms, catheter ablation offers a more definitive approach by addressing the root cause of the condition. Researchers are excited about this treatment because it has the potential to offer long-term relief from AF symptoms, particularly for those who don't respond well to medication. Additionally, catheter ablation can reduce the risk of stroke and improve quality of life by maintaining a regular heartbeat.
What evidence suggests that catheter ablation might be an effective treatment for atrial fibrillation?
Research has shown that catheter ablation, one of the treatments studied in this trial, can benefit people with atrial fibrillation (AF), particularly those with heart failure. Studies have found that this procedure significantly reduces hospital visits and improves quality of life by maintaining normal heart rhythm. For instance, one study found that 56% of patients who underwent catheter ablation were free of AF symptoms after a year. Another study demonstrated that catheter ablation made it seven times less likely for AF to progress from occasional to persistent over three years. Overall, catheter ablation has proven more effective than medication alone in reducing AF symptoms and improving heart health, which is the focus of the other treatment arm in this trial.678910
Who Is on the Research Team?
Pier Lambiase
Principal Investigator
University College, London
Mark Petrie
Principal Investigator
University of Glasgow
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either catheter ablation and optimal medical therapy or optimal medical therapy alone
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of QoL at 6 and 12 months
Long-term Follow-up
Participants are monitored for primary and secondary outcomes, including time to all-cause death and urgent CV hospitalisations
What Are the Treatments Tested in This Trial?
Interventions
- Catheter Ablation
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Catheter ablation is an established therapeutic strategy in patients without HF that aims to convert AF to sinus rhythm in symptomatic, drug-refractory AF in patients.
Participants randomised to the optimal medical therapy arm will receive optimal medical therapy according to the most contemporary ESC HF guidelines.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University College, London
Lead Sponsor
Citations
Atrial Fibrillation (AF) Catheter Ablation Success Rates
It indicated that 52% of patients having an atrial fibrillation catheter ablation were successful and symptom-free without antiarrhythmic drugs. An additional ...
Temporal trends in atrial fibrillation catheter ablation efficacy
A significant improvement in efficacy was observed over time (+1.09% per year; 95% confidence interval: 0.71% to 1.56%; P < 0.0001; R2 = 7%). However, this ...
Catheter Ablation in End-Stage Heart Failure with Atrial ...
At 12 months, 54 of 97 patients (56%) in the ablation group were free of primary end-point events and not in persistent atrial fibrillation, as compared with 9 ...
Long‐term Outcomes of Catheter Ablation of Atrial Fibrillation
Mean long‐term success in the studies separately reporting PAF outcome was 54.1% (95% CI 44.4% to 63.4%, Figure 2B), and in the 4 studies ...
The Effectiveness of Ablation Therapy for Atrial Fibrillation - PMC
The catheter ablation for atrial fibrillation with heart failure (CASTLE-AF) trial showed that AFCA decreased the main goal of all-cause death ...
Safety and efficacy of catheter ablation for atrial fibrillation ...
The primary safety outcomes were observed in 3 patients. One patient experienced prolonged superficial bleeding from the wound edges (femoral ...
Atrial Fibrillation (AF) Catheter Ablation Risks
Data from the US analyzing an estimated 93,801 ablation procedures conducted from 2000 to 2010 found an overall complication rate of 6.29% and in-hospital ...
Atrial Fibrillation Ablation: Safety in Numbers∗
Deaths associated with atrial fibrillation ablation were very rare, at 0.05% over the last 5-year reporting interval. Additionally, Benali et al ...
Procedural Patterns and Safety of Atrial Fibrillation Ablation
This study describes patient characteristics, techniques, treatment patterns, and safety outcomes of patients undergoing AF ablation.
Catheter Ablation for Atrial Fibrillation—Influence of ...
Study outcomes are presented in Table 3. Acutely successful PVI was achieved in 92% of patients (similar for CB and RF ablation). However, only 52% (n=74) met ...
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