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

Primary Purpose

Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation

Status
Withdrawn
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Catheter ablation
Convergent procedure
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Atrial Fibrillation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UMC Ljubljana

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Catheter ablation group

Convergent group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Noninferiority of catheter ablation
arrhythmia-free survival registered with an implantable loop recorder

Secondary Outcome Measures

Differences in AF burden
registered with an implantable loop recorder
Differences in acute success rate of posterior wall isolation
registered with voltage and activation mapping during the index procedure
Differences in complication rate
procedure related complications

Full Information

First Posted
August 7, 2020
Last Updated
January 15, 2023
Sponsor
University Medical Centre Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT04509180
Brief Title
Comparison of Treatment Outcomes Between Convergent Procedure and Catheter Ablation for Persistent and Longstanding Persistent Atrial Fibrillation
Official Title
Comparison of Treatment Outcomes Between Convergent Procedure and Catheter Ablation for Persistent and Longstanding Persistent Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
February 26, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Catheter ablation group
Arm Type
Experimental
Arm Description
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.
Arm Title
Convergent group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Catheter ablation
Intervention Description
Endovascular approach
Intervention Type
Procedure
Intervention Name(s)
Convergent procedure
Intervention Description
Surgical and endovascular approach
Primary Outcome Measure Information:
Title
Noninferiority of catheter ablation
Description
arrhythmia-free survival registered with an implantable loop recorder
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Differences in AF burden
Description
registered with an implantable loop recorder
Time Frame
1 year
Title
Differences in acute success rate of posterior wall isolation
Description
registered with voltage and activation mapping during the index procedure
Time Frame
1 month
Title
Differences in complication rate
Description
procedure related complications
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
UMC Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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