Ablation for Atrial Flutter

Overseen By Gregory Panza, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hartford Hospital

Disqualifiers: Pacemaker, Defibrillator, Inpatient, others

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

Compensation: Varies

Number of Visits: 2

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating atrial flutter (a type of irregular heartbeat) by performing a procedure through the arm instead of the groin. Researchers aim to determine if this new approach can shorten recovery time, maintain success rates, and reduce complications. The study compares the traditional ablation through the femoral vein (a procedure using radiofrequency energy to destroy abnormal heart tissue) with the experimental ablation through the arm. It seeks participants diagnosed with typical atrial flutter who are scheduled for an outpatient procedure. Participants must weigh at least 110 pounds and have an EKG or telemetry showing typical atrial flutter. As an unphased trial, this study offers the chance to contribute to innovative research that could enhance treatment options for atrial flutter.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since patients are typically discharged on oral anticoagulation after the procedure, it's best to discuss your current medications with the trial team.

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

Research has shown that ablation procedures for atrial flutter are generally safe and well-tolerated. For instance, one study found that catheter ablation of atrial flutter significantly reduced the risk of complications like heart failure over time.

Another study discovered that high-power, short-duration radiofrequency ablation for typical atrial flutter is both safe and effective. Although some patients might experience atrial fibrillation (an irregular heartbeat) after the procedure, this risk is usually manageable.

Overall, ablation through the arm is a new method being explored for its potential benefits, such as quicker recovery times and fewer complications at the access site. Based on past experiences with similar techniques, this treatment is considered safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for atrial flutter because they offer new methods of delivering ablation therapy. Unlike traditional ablation, which is typically performed through the femoral vein, one of these treatments uses the left arm, potentially offering a less invasive option. This alternative approach might reduce recovery time and improve patient comfort. Both methods aim to efficiently target and eliminate the abnormal electrical signals causing the arrhythmia, but the arm-based approach could provide a more accessible route for some patients.

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

This trial will compare two methods of ablation for treating atrial flutter. Studies have shown that treating typical atrial flutter through the leg's main vein (femoral vein) is highly effective, with success rates up to 92% after just one procedure. This method uses radio waves to stop abnormal heart signals. Recent improvements in tools and techniques have made these procedures quicker and possibly safer. In this trial, one group will receive ablation through the femoral vein, while another group will receive ablation through the arm. Although less information exists about the arm approach, it seems promising because it might help patients recover faster and reduce certain risks. Using the arm could help avoid problems like bleeding in the groin area, which can occur with the leg approach. However, more research is needed to determine if this new method is as effective as the traditional one. ^{2 6 7 8 9}

Who Is on the Research Team?

Aneesh Tolat, MD

Principal Investigator

Hartford Hospital

Are You a Good Fit for This Trial?

This trial is for outpatients weighing at least 50 kg with documented typical atrial flutter, referred for right atrial flutter ablation. It's not open to inpatients, those unable to consent, individuals under 50 kg, or patients with a pacemaker or defibrillator with transvenous leads.

Inclusion Criteria

I am scheduled for a procedure to correct heart flutter as an outpatient.

You have a specific heart rhythm problem called atrial flutter, which has been confirmed by a heart test called EKG or telemetry.

I weigh at least 110 pounds.

Exclusion Criteria

I am currently admitted to a hospital.

You have a pacemaker or defibrillator with certain types of leads.

My body weight is under 50 Kg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Ablation of typical right atrial flutter through the arm or femoral vein

1 day

1 visit (in-person)

Recovery

Participants are monitored immediately after the procedure for recovery and discharge

4 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

1 year

In-person visits and phone call or chart evaluations

What Are the Treatments Tested in This Trial?

Interventions

• Ablation through femoral vein
• Ablation through left arm

Trial Overview

The study tests the safety and effectiveness of performing atrial flutter ablation through the arm instead of the femoral vein. It compares recovery time, success rates of maintaining sinus rhythm without recurrence, complication rates including bleeding and heart issues, and pain severity at insertion sites between both methods.

How Is the Trial Designed?

Group I: Ablation through upper extremity Experimental Treatment 1 Intervention

Ablation through arm

Group II: Ablation through femoral vein Active Control 1 Intervention

Ablation through vein

Ablation through femoral vein is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Catheter Ablation for:

• Symptomatic atrial flutter
• Refractory atrial flutter
• Atrial fibrillation

Approved in United States as Catheter Ablation for:

• Symptomatic atrial flutter
• Refractory atrial flutter
• Atrial fibrillation

Approved in Canada as Catheter Ablation for:

• Symptomatic atrial flutter
• Refractory atrial flutter
• Atrial fibrillation

Who Is Running the Clinical Trial?

Hartford Hospital

Lead Sponsor

Trials

140

Recruited

19,700+

Published Research Related to This Trial

Catheter ablation has become the primary treatment for atrial flutter, a condition caused by a reentrant circuit in the heart, and involves precise mapping and interruption of this circuit.

Successful ablation requires creating lesions in specific areas to block the flutter circuit, ensuring the tachycardia is terminated and conduction is effectively interrupted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catheter ablation of atrial flutter and macroreentrant atrial tachycardia. Wu, RC., Berger, R., Calkins, H.[2019]

In a study of 448 patients undergoing atrial flutter ablation, using a gold-tip catheter and setting the maximum temperature to 70°C significantly increased the success rate of the procedure to 100%.

The optimal combination of ablation settings not only achieved complete success but also reduced the median cumulative ablation time from 8.3 minutes to just 4.3 minutes, demonstrating both efficacy and efficiency in the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An optimized approach for right atrial flutter ablation: a post hoc analysis of the AURUM 8 study. Lewalter, T., Weiss, C., Mewis, C., et al.[2018]

Catheter ablation is highly effective for treating typical atrial flutter, achieving success rates of 95 to 98% and a low risk of recurrence.

While catheter ablation has a low complication rate, it is not without risks, and careful consideration is necessary before proceeding with the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transoesophageal echocardiography prior to atrial flutter ablation averts a dramatic complication. Michael, KA., Johri, A., Baranchuk, A.[2016]

Catheter ablation is an effective first-line treatment option for patients suffering from symptomatic typical atrial flutter, providing palliative relief.

This intervention is particularly beneficial for managing symptoms associated with atrial flutter, improving patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should ablation be the first line treatment for supraventricular arrhythmias? Cosío, FG.[2018]

New antiarrhythmic medications can effectively manage atrial flutter and fibrillation in many patients, but some episodes may still need cardioversion to restore normal heart rhythm.

Catheter ablation is a promising treatment for patients with persistent atrial flutter, while ablation for atrial fibrillation is more complex and still considered experimental, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic options in atrial flutter and fibrillation. Wilber, DJ., Gunnar, RM.[2019]

A nationwide study of 33,353 catheter ablation cases for atrial fibrillation and flutter in Germany revealed higher overall complication rates (11.7% to 13.8% for left atrial ablations) than previously reported, highlighting the need for more accurate assessments of real-world risks.

Atrial flutter ablations showed a concerningly high rate of major complications (10.5%), with in-hospital death occurring four times more often after right atrial ablations compared to left, indicating that patient age and existing health conditions significantly impact safety outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of complications related to catheter ablation of atrial fibrillation and atrial flutter: a nationwide in-hospital analysis of administrative data for Germany in 2014. Steinbeck, G., Sinner, MF., Lutz, M., et al.[2019]

In a study of 883 patients undergoing radiofrequency ablation for atrial flutter, 5% experienced adverse events (AEs), with 14 cases being life-threatening, highlighting the need for careful monitoring during the procedure.

Most AEs were linked to the use of rate-control medications, particularly in females and those with heart disease, suggesting that better management of anticoagulants and medications could reduce the risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is ablation of atrial flutter always safe? Brembilla-Perrot, B., Filali, ML., Zinzius, PY., et al.[2012]

Radiofrequency catheter ablation is an effective curative treatment for typical atrial flutter, achieving acute success rates of 85-90% and low recurrence rates of 10-15% when a bidirectional isthmus block is confirmed.

While successful ablation of atrial flutter can reduce the incidence of paroxysmal atrial fibrillation, about 20% of patients may still experience new-onset atrial fibrillation after the procedure, highlighting the need for further treatment options for atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Radiofrequency catheter ablation of atrial flutter and atrial fibrillation]. Reithmann, C., Hoffmann, E., Steinbeck, G.[2019]

Catheter ablation is the preferred treatment for atrial flutter, achieving high success rates of 95% in specialized centers, with low relapse rates of 5%-10%.

For atrial fibrillation, while catheter ablation of the AV junction can improve quality of life, it does not enhance survival, and curative options like the surgical maze operation are typically reserved for patients undergoing other cardiac surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonpharmacologic Therapy of Atrial Fibrillation and Atrial Flutter. Plumb, VJ., Windecker, S., Epstein, AE., et al.[2019]

Catheter ablation, particularly using radiofrequency (RF) technology, is highly effective for treating various arrhythmias, especially supraventricular types, by targeting small and discrete areas of the heart.

Advancements in RF catheter designs and techniques, including temperature monitoring and the development of a catheter-based 'maze' procedure for atrial fibrillation, are expected to enhance the success rates of ablation for more complex arrhythmias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New horizons in catheter ablation. Haines, DE., Nath, S.[2019]

In a study of 84 patients undergoing radiofrequency catheter ablation (RFA) for atrial flutter, the procedure achieved a high success rate of 96.5% during the first treatment, indicating its efficacy as a curative option.

No serious complications were reported during the RFA procedures, suggesting that this treatment is safe for patients with recurrent or incessant atrial flutter.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Radiofrequency catheter ablation of atrial flutter]. Ohm, OJ., Chen, J., Hoff, PI., et al.[2016]

Radiofrequency catheter ablation is an effective and minimally invasive treatment for atrial flutter, particularly for the common type, with a high success rate and few complications.

This technique is also a curative option for paroxysmal atrial fibrillation, targeting the pulmonary veins to prevent the initiation of arrhythmias, although patients with left atrial flutter or heart disease may have poorer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Catheter ablation of atrial flutter and paroxysmal atrial fibrillation]. Márquez, MF.[2006]

Radiofrequency catheter ablation for common atrial flutter demonstrated a high success rate, with 90% of patients having their atrial flutter interrupted after a single session, based on a study of 80 patients.

The most effective target site for the ablation was found to be the isthmus between the inferior vena cava orifice and the tricuspid valve, achieving a success rate of 70% when radiofrequency lesions were applied in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiofrequency catheter ablation of common atrial flutter in 80 patients. Fischer, B., Haissaguerre, M., Garrigues, S., et al.[2010]

Citations

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Catheter ablation of atypical left atrial flutter | Oxford Academic

Outcomes after catheter ablation of left atrial flutter (LAF) are still suboptimal. Challenges include limitations in both mapping and ablation ...

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All targeted AFL circuits were successfully ablated. When using PFA alone, acute procedural success was 96.5% (95% CI: 94.03%-98.11%), with ...

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jacc.org

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In terms of outcomes, per-ablation success rates at 5-year follow-up before vs after the use of CF sensing catheters were 35% vs 57% (P = 0.807) ...

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Atrial fibrillation occurred in 14 of 53 patients after successful ablation (26.4%). Four clinical variables were associated by univariate analysis with the ...

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Impact of catheter ablation in patients with atrial flutter and ...

In patients with AFL and HFrEF, AFL ablation was associated with lower mortality and HF readmissions at 1 year. Patients with AFL and HFpEF did not show a ...

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jacc.org

jacc.org/doi/10.1016/j.jaccas.2025.104184

Safety, Efficacy, and 2-Year Outcomes of Cardiovascular ...

Interventional CMR-guided ablation of CTI-dependent atrial flutter demonstrates a good safety profile and efficacy at 2-year follow-up. Open in ...

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This study aimed to assess the safety and feasibility of catheter ablation for AF in an ADSC in a non-hospital setting.

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High-power short-duration radiofrequency ablation of typical ...

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 ...