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

Trial Summary

What is the purpose of this trial?

Typical atrial flutter ablation involving forming a line of block across the cavotricuspid isthmus in the right atrium has become a commonly performed procedure and is considered a class I indicated procedure for patients who wish to pursue maintenance of sinus rhythm. The ablation generally involves 2-3 catheters and is typically performed through the femoral vein(s). After the ablation procedure, the patient is placed on bed rest for 4 hours, and typically discharged home the same day on oral anticoagulation. Catheter technology has improved over the past several years allowing for more rapid ablation with shorter procedure times. Ultrasound has also become more routinely used when obtaining venous access for the patient. To date, ablation of typical atrial flutter through the left or right arm has not been reported. Diagnostic electrophysiology studies have been performed through the arm and AV node ablation has also been reported from the cephalic, internal jugular, axillary and subclavian veins. The potential benefits include shorter recovery time, reduced risk of retroperitoneal bleed, and the avoidance of access complications from the groin. This study aims to evaluate the safety, feasibility, and efficacy of performing typical atrial flutter ablation through the arm. Specifically, the study will aim to: 1. Compare the recovery time immediately after the procedure using upper extremity access compared to the standard approach. 2. Compare the success rate of patients that undergo ablation of typical atrial flutter through the upper extremity venous system (experimental approach) to the standard approach (i.e., through the femoral vein(s). Success will be defined as ablation that leads to evidence for bidirectional block across the right atrial cavotricuspid isthmus. 3. Establish what the potential complications are from performing typical atrial flutter through the left or right arm. The left arm will be the preferred site for access because of less tortuosity to reach the heart. If one side cannot be accessed the alternate arm will be used, but will be left to the discretion of the operator. The operator will have the discretion to switch to a femoral approach at any time. 4. Compare the complication rates of the experimental approach evaluated by the inability to access the vein, and other complications (e.g., bleeding, vein thrombosis, heart perforation) from accessing the vein in the arm to the complication rates of the standard approach. 5. Compare long term (i.e., 1 month and 1 year) success of the experimental approach vs. the standard approach as assessed by maintenance of normal sinus rhythm, without recurrent typical right atrial flutter with in person visits and phone call or chart evaluations. 6. Compare pain severity of the insertion site between the experimental and standard approaches.

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 data supports the effectiveness of the treatment Ablation for Atrial Flutter?

Studies show that radiofrequency catheter ablation is highly effective for treating typical atrial flutter, with success rates of 85-95% and low recurrence rates. It is considered the treatment of choice for this condition, offering a curative approach with minimal complications. ^{1 2 3 4 5}

Is ablation for atrial flutter safe?

Ablation for atrial flutter is generally considered safe, with high success rates and low complication rates, but it is not entirely risk-free and should be approached carefully. ^{1 6 7 8 9}

How is ablation treatment for atrial flutter different from other treatments?

Ablation treatment for atrial flutter is unique because it uses radiofrequency energy to target and disrupt the electrical pathways causing the irregular heartbeat, offering a curative approach with high success rates and minimal complications, unlike other treatments that may only manage symptoms. ^{1 10 11 12 13}

Research Team

Aneesh Tolat, MD

Principal Investigator

Hartford Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. Mexico pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Therapeutic options in atrial flutter and fibrillation. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

[Radiofrequency catheter ablation of atrial flutter and atrial fibrillation]. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Nonpharmacologic Therapy of Atrial Fibrillation and Atrial Flutter. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

New horizons in catheter ablation. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Radiofrequency catheter ablation of common atrial flutter in 80 patients. [2010]

7. South Africa pubmed.ncbi.nlm.nih.gov

Transoesophageal echocardiography prior to atrial flutter ablation averts a dramatic complication. [2016]

8. England 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. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Is ablation of atrial flutter always safe? [2012]

10. Norway pubmed.ncbi.nlm.nih.gov

[Radiofrequency catheter ablation of atrial flutter]. [2016]

11. United States pubmed.ncbi.nlm.nih.gov

Catheter ablation of atrial flutter and macroreentrant atrial tachycardia. [2019]

12. Netherlands pubmed.ncbi.nlm.nih.gov

An optimized approach for right atrial flutter ablation: a post hoc analysis of the AURUM 8 study. [2018]

13. England pubmed.ncbi.nlm.nih.gov

Should ablation be the first line treatment for supraventricular arrhythmias? [2018]