High Power Radiofrequency Ablation for Atrial Flutter

(AITAF Trial)

Overseen By Stephen Wilton, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Must not be taking: Anti-arrhythmics, others

Disqualifiers: Congenital heart disease, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for atrial flutter, a type of irregular heartbeat. The study compares two methods of using radiofrequency energy to address the problem area in the heart. One method uses a higher power setting (50 Watts), while the other uses a standard setting (30 Watts). This involves ablation of the cavo-tricuspid isthmus, a procedure aimed at correcting typical atrial flutter. Individuals who have experienced at least one episode of atrial flutter and have not undergone this specific treatment may be suitable for the trial. The goal is to determine if the high-power method works faster and more effectively. As an unphased trial, this study provides a unique opportunity to explore innovative treatment methods for atrial flutter.

Will I have to stop taking my current medications?

If you are taking anti-arrhythmic drugs like flecainide, sotalol, or amiodarone, you will need to stop them 3 days before the procedure and not restart them afterward. For other medications, the protocol does not specify.

What prior data suggests that this ablation technique is safe for atrial flutter?

Research has shown that radiofrequency ablation, a procedure using heat to remove abnormal heart tissue, is generally safe for treating atrial flutter. One study found that high-power, short-duration settings for this procedure proved effective and well-tolerated, with patients experiencing fewer side effects and requiring less pain relief. Another study confirmed that radiofrequency ablation remains the most common and safe method for this heart issue. Evidence suggests that both the 30 Watt and 50 Watt settings in the trial are likely safe, as they are variations of a widely used technique with a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about high power radiofrequency ablation for atrial flutter because it offers a potentially more effective approach to treating this common heart rhythm disorder. Unlike traditional ablation treatments that typically use lower power settings, this technique explores using higher power levels—30 Watts and 50 Watts—to ablate the cavo-tricuspid isthmus. The higher power settings might lead to quicker and more complete ablation, potentially reducing procedure time and improving patient outcomes. This trial could pave the way for more efficient treatment protocols, offering hope for faster recovery and better long-term rhythm control for patients.

What evidence suggests that this trial's treatments could be effective for atrial flutter?

This trial will compare the effectiveness of different power settings for radiofrequency ablation in treating atrial flutter. Research has shown that high-power short-duration (HPSD) radiofrequency ablation effectively treats atrial flutter, a type of irregular heartbeat. Participants in this trial will be assigned to either a 30 Watt or a 50 Watt power setting. Studies have found that higher power settings, like 50 Watts, can make the procedure quicker than the usual 30 Watt settings. This faster approach may also lead to better results, with fewer cases of the condition returning. Evidence indicates that patients treated with HPSD ablation have lower chances of atrial flutter recurrence. Overall, this method is considered safe and effective for many people with this heart rhythm problem. ^{3 4 5 6 7}

Who Is on the Research Team?

George Veenhuyzen, M.D.

Principal Investigator

University of Calgary

Rory P Dowd, MBBS, MEng

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for individuals with a type of rapid heartbeat called atrial flutter. Participants should be suitable candidates for a procedure that burns (ablates) the area causing the flutter in their heart. Specific details on who can or cannot join are not provided, but typically involve health status and history.

Inclusion Criteria

Clinically determined by a cardiac electrophysiologist to have had at least one episode of CTI dependent atrial flutter

Able and willing to comply with all protocol requirements

Agree to and sign patient Informed Consent Form (ICF)

Exclusion Criteria

I have a congenital heart condition.

I am not pregnant or breastfeeding.

I will be under general anesthesia for my procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo radiofrequency ablation with either 30W or 50W power settings to achieve CTI block

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including recurrence of atrial flutter and presence of durable CTI block

3 months

Follow-up visits as needed, including ECGs and Holter monitoring

What Are the Treatments Tested in This Trial?

Interventions

• Ablation of the Cavo-tricuspid isthmus for typical Atrial Flutter

Trial Overview The study compares two ways to perform heart ablation: one uses high power at 50 Watts for a short time, while the other uses standard power at 30 Watts. The goal is to see if higher power makes the procedure quicker without compromising safety or effectiveness.

How Is the Trial Designed?

Group I: 50 Watt Experimental Treatment 1 Intervention

Power set to 50 Watts

Group II: 30 Watt Active Control 1 Intervention

Power set to 30 Watts

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34113888/

High-power short-duration radiofrequency ablation of ... Objective: The purpose of this study was to evaluate the safety, efficacy, and clinical outcomes of HPSD ablation in patients with typical ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666501820301185

High-power short-duration radiofrequency ablation of ... The purpose of this study was to evaluate the safety, efficacy, and clinical outcomes of HPSD ablation in patients with typical atrial flutter compared to those ...

3. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(25)02630-X/fulltext

Ablation of cavotricuspid isthmus–dependent atrial flutter ... The purpose of this study was to evaluate the feasibility of CTI ablation using a monopolar focal pulsed-field ablation (F-PFA) catheter and to ...

4. revespcardiol.org revespcardiol.org/en-radiofrequency-ablation-of-the-cavotricu-articulo-13024743-pdf-file

Radiofrequency Ablation of the Cavotricuspid Isthmus in ... The aim of our study is to compare the effective- ness of radiofrequency ablation of the cavotricuspid isthmus using Irrigated-tip catheters compared with.

5. ahajournals.org ahajournals.org/doi/10.1161/circep.109.871665

Long-Term Outcomes After Catheter Ablation of Cavo- ... Atrial flutter recurrence rates were significantly reduced by use of 8- to 10-mm tip or irrigated radiofrequency catheters (6.7% versus 13.8%, P ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35378611/

Cavotricuspid isthmus ablation by means of very high ... Conclusions: Our preliminary data show that the vHPSD ablation represents an effective and safe ablation strategy to achieve bidirectional block ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666084925009659

Safety, Efficacy, and 2-Year Outcomes of Cardiovascular ... Long-term outcomes after catheter ablation of cavo-tricuspid isthmus dependent atrial flutter: a meta-analysis. Circ Arrhythm Electrophysiol ...