Comparison of Treatment Outcomes Between Convergent Proce... | NCT04509180

Status Module

Oversight Module

Description Module

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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Catheter ablation group	Experimental	Patients undergoing catheter procedure will be put under conscious sedation and local anesthesia. Pulmonary vein isolation and posterior wall isolation will be performed with a radiofrequency ablation catheter (20-45W, open-tip irrigation). Ablation index will be used for the lesion formation guidance (450-500 on anterior aspects; 350-400 on the posterior aspects). A wide antral circumferential ablation will be performed for pulmonary veins and a box lesion set for the posterior left atrial wall. Voltage mapping and signal analysis performed by the operator will be used to assess electrical isolation of the pulmonary veins and posterior wall and to identify gaps in ablation lines. At the end of procedure, an implantable loop recorder will be inserted in the left parasternal region.	Procedure: Catheter ablation
Convergent group	Active Comparator	Patients undergoing convergent procedure will be put under general anesthesia. A minimally invasive epicardial radiofrequency ablation (30W, 90s) of posterior wall will be performed through a subxiphoid window. Monitoring of the esophageal temperature will be performed with an esophageal temperature probe set at 38°C. Next, an endocardial radiofrequency ablation (20-40W, open-tip irrigation; ablation index 450-500 anteriorly and 350-400 posteriorly) of pulmonary veins in a wide antral circumferential fashion will be performed. Voltage mapping and signal analysis performed by the operator will be used to assess the electrical isolation of the pulmonary veins and posterior wall and to identify the gaps in ablation lines. At the end of procedure, an implantable loop recorder will be inserted in the left parasternal region.	Procedure: Convergent procedure

Name	Type	Description	Arm Group Labels	Other Names
Catheter ablation	Procedure	Endovascular approach	Catheter ablation group

Outcomes Module

Measure	Description	Time Frame
Noninferiority of catheter ablation	arrhythmia-free survival registered with an implantable loop recorder	1 year

Secondary Outcomes

Measure	Description	Time Frame
Differences in AF burden	registered with an implantable loop recorder	1 year
Differences in acute success rate of posterior wall isolation	registered with voltage and activation mapping during the index procedure

Eligibility Module

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000078703	Radiofrequency Ablation
D000078702	Radiofrequency Therapy
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative