Comparison of Treatment Outcomes Between Convergent Procedure and Catheter Ablation for Persistent and Longstanding Persistent Atrial Fibrillation

Persistent Atrial Fibrillation Clinical Trial

Official title:

Comparison of Treatment Outcomes Between Convergent Procedure and Catheter Ablation for Persistent and Longstanding Persistent Atrial Fibrillation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04509180
• Other study ID #: 0120-161/2020/4
• Status: Withdrawn
• Phase: N/A
• Start date: February 26, 2021
• Est. completion date: September 1, 2024

Study information

• Verified date: January 2023
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the last 20 years, atrial fibrillation has become one of the leading healthcare burden in Europe and other developed countries. With an ever-increasing prevalence and incidence, atrial fibrillation is expected to remain a significant problem in the near future. Due to numerous detrimental effects atrial fibrillation has on the patient's health, having an efficient and safe treatment is crucial for managing the problem.

The gold standard for an atrial fibrillation treatment is a catheter ablation. In typical catheter ablation procedure, triggers in pulmonary veins are addressed with a pulmonary vein isolation- offering a high long-term success rate in patients with paroxysmal atrial fibrillation. However, the same cannot be said for persistent and longstanding persistent atrial fibrillation. Studies have shown that efficiency of catheter ablation for persistent and longstanding persistent atrial fibrillation, including multiple procedures per patient, ranges around 50 %. It is postulated that extrapulmonary vein triggers, such as foci located in the posterior wall of the left atrium, play an important role in initiating and maintaining persistent and longstanding persistent atrial fibrillation. In the past, to address this issue, a convergent procedure was developed. In convergent procedure an epicardial ablation of posterior wall is performed through a subxyphoid window. Next, an endocardial ablation with an ablation catheter is performed to isolate pulmonary veins. Because the epicardial lesions are applied in the opposite direction and not towards the esophagus, ablation of posterior wall can safely be performed. The procedure offers a high long-term success rate (85%) in patients with persistent and longstanding persistent atrial fibrillation. However, due to higher associated invasiveness, the convergent procedure carries a higher risk of complications compared with catheter ablation (4 % vs 9 %).

With advancements in ablation catheter technology, such as continuous force measurement at the tip of the catheter, the depth and volume of the lesion can be estimated. This information greatly increases the reliability of lesion formation. The operator can thus effectively apply lesions to the posterior wall of the left atrium more safely in regards to the collateral damage to the esophagus.

The objectives of the study are:

• To compare procedural, safety and efficiency profile of convergent procedure with catheter ablation procedure, both targeting pulmonary veins triggers and triggers located in the posterior wall of the left atrium.

• To compare long-term success rate of convergent procedure with catheter ablation procedure, both targeting pulmonary veins triggers and triggers located in the posterior wall of the left atrium.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosed persistent and/or long-term

• Failed medical therapy with antiarrhythmic drug therapy

Exclusion Criteria:

• Expected life expectancy of less than one year

• Previous heart operation

• Previous ablation procedure

• Left ventricular ejection fraction below 30 %

• Severe valvular heart disease

• Acute coronary syndrome

• Diminished functional capacity due to non-cardiac co-morbidities

• Pregnancy

Related Conditions & MeSH terms

• Atrial Fibrillation
• Longstanding Persistent Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Procedure:
• Catheter ablation
Endovascular approach
• Convergent procedure
Surgical and endovascular approach

Locations

Country	Name	City	State
Slovenia	UMC Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Noninferiority of catheter ablation	arrhythmia-free survival registered with an implantable loop recorder	1 year
Secondary	Differences in AF burden	registered with an implantable loop recorder	1 year
Secondary	Differences in acute success rate of posterior wall isolation	registered with voltage and activation mapping during the index procedure	1 month
Secondary	Differences in complication rate	procedure related complications	1 month