NCT04509180

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

February 26, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

1.5 years

First QC Date

August 7, 2020

Last Update Submit

January 15, 2023

Conditions

Persistent Atrial FibrillationLongstanding Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Noninferiority of catheter ablation

    arrhythmia-free survival registered with an implantable loop recorder

    1 year

Secondary Outcomes (3)

  • Differences in AF burden

    1 year

  • Differences in acute success rate of posterior wall isolation

    1 month

  • Differences in complication rate

    1 month

Study Arms (2)

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

Interventions

Catheter ablationPROCEDURE

Endovascular approach

Catheter ablation group
Convergent procedurePROCEDURE

Surgical and endovascular approach

Convergent group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed persistent and/or long-term
  • Failed medical therapy with antiarrhythmic drug therapy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 7, 2020

First Posted

August 11, 2020

Study Start

February 26, 2021

Primary Completion

September 1, 2022

Study Completion

September 1, 2024

Last Updated

January 18, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)