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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04509180
Enrollment
0
Registered
2020-08-11
Start date
2021-02-26
Completion date
2024-09-01
Last updated
2023-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Longstanding Persistent Atrial Fibrillation, Persistent Atrial Fibrillation

Brief 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.

Interventions

PROCEDURECatheter ablation

Endovascular approach

PROCEDUREConvergent procedure

Surgical and endovascular approach

Sponsors

University Medical Centre Ljubljana
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Noninferiority of catheter ablation1 yeararrhythmia-free survival registered with an implantable loop recorder

Secondary

MeasureTime frameDescription
Differences in AF burden1 yearregistered with an implantable loop recorder
Differences in acute success rate of posterior wall isolation1 monthregistered with voltage and activation mapping during the index procedure
Differences in complication rate1 monthprocedure related complications

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026