Giant Left Atrium Atrial fibrillatioN CathEter Ablation, Posterior Box Isolation vs. Dallas Lesion Set

NCT04632550 | Unknown DMC

• 1 other identifier: 4-2020-0954
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

Although the additional linear ablation after pulmonary vein isolation (PVI) is a class IIB indication for AF catheter ablation in patients with persistent AF, no clear benefit has been demonstrated in the recent randomized clinical trials (STAR-AF2 or POBI trials). Nevertheless, in the retrospective cohort data of this research team, additional POBI and AL were helpful in persistent AF patients with left atrial (LA) size \> 50mm or more or low LA voltage. The purpose of this study was to evaluate the efficacy and safety of additional POBI and AL compared to CPVI alone in persistent AF patients with LA size over 50mm. Also, we intend to proceed with this randomized clinical trial with the high power short duration ablation protocol, which is effective in shortening the procedure time.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (4)

• Safety evaluation: Procedure-related cardiac complication rate

  -including open cardiac surgery, cerebral infarction, pericardial effusion or cardiac tamponade, hematoma in the inguinal puncture site and vascular complications within 30 days post procedure.

  within 30 days post procedure

• Efficacy evaluation: clinical recurrence rate

  \- Defined as atrial fibrillation or atrial tachycardia \> 30 sec after 3 months within 1 year; based on the 2012 ACC/AHA/HRS guidelines, 24-hour Holter ECG monitoring will be performed at 2 month and every 6 months, and ECG and monitoring with a Holter or an event recorder will be performed at any time if the patient complains of symptoms

  Within 1 year after 3 months of procedure

• Efficacy evaluation: Major cardiovascular event rate

  \- death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure

  immediate after procedure

• Efficacy evaluation: Major cardiovascular event rate

  \- death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure

  12 months after procedure

Secondary Outcomes (5)

• procedure time

  immediate after the procedure

• hospitalization duration

  immediate after the discharge

• Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate

  immediate after the procedure, 1 week, 3,6,12,18,24,36 months after procedure.

• rate of electrical cardioversion

  immediate after the procedure, 1 week, 3,6,12,18,24,36 months after procedure.

• rate of cardiovascular hospitalization

  immediate after the procedure, 1 week, 3,6,12,18,24,36 months after procedure.

Study Arms (3)

Circumferential pulmonary vein isolation(CPVI) group

ACTIVE COMPARATOR

Procedure: Circumferential pulmonary vein isolation(CPVI) group

Posterior box isolation(POBI) group

EXPERIMENTAL

Procedure: Posterior box isolation(POBI) group

POBI+Anterior linear ablation(AL) group

EXPERIMENTAL

Procedure: POBI+Anterior linear ablation(AL) group

Interventions

Circumferential pulmonary vein isolation(CPVI) group PROCEDURE

1. PVI(pulmonary vein isolation) will be performed using a radiofrequency catheter 2. Esophageal temperature will be monitored to prevent esophageal injury. 3. Evaluation of procedure time, radiofrequency ablation time 4. Evaluation of the complication after the procedure. 5. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.

Circumferential pulmonary vein isolation(CPVI) group

Posterior box isolation(POBI) group PROCEDURE

1. PVI will be performed using a radiofrequency catheter 2. Additional POBI(Posterior box isolation) is performed according to the traditional method and experience of the practitioner. 3. Esophageal temperature will be monitored to prevent esophageal injury. 4. The bidirectional block of each lesion set is the target of the procedures. But, we remain the incomplete block if three times of linear ablation failed to achieve the bidirectional block for the safety purpose. 5. Evaluation of procedure time, radiofrequency ablation time 6. Evaluation of the complication after the procedure. 7. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.

Posterior box isolation(POBI) group

POBI+Anterior linear ablation(AL) group PROCEDURE

1. PVI, POBI will be performed using a radiofrequency catheter 2. Additional AL(anterior linear) ablation is performed according to the traditional method and experience of the practitioner. 3. Esophageal temperature will be monitored to prevent esophageal injury. 4. The bidirectional block of each lesion set is the target of the procedures. But, we remain the incomplete block if three times of linear ablation failed to achieve the bidirectional block for the safety purpose. 5. Evaluation of procedure time, radiofrequency ablation time 6. Evaluation of the complication after the procedure. 7. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.

POBI+Anterior linear ablation(AL) group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with persistent atrial fibrillation who is scheduled for ablation procedure and ≥20 and ≤80 years of age
• Left atrium size ≥ 50mm
• Persistent atrial fibrillation that is recurrence during antiarrhythmic drug treatment or is not able to use an antiarrhythmic drug.
• Patient who is indicated for anticoagulation therapy (for prevention of cerebral infarction)

You may not qualify if:

• AF Patients with LA size less than 50mm
• Atrial fibrillation associated with severe cardiac malformation or a structural heart disease that is hemodynamically affected
• Patients with severe renal impairment or CT imaging difficulty using contrast media
• Patients with a past history of radiofrequency ablation for atrial fibrillation or other cardiac surgery
• Patients with active internal bleeding
• Patients with contraindications for anticoagulation therapy(for prevention of cerebral infarction) and antiarrhythmic drugs
• Patients with valvular atrial fibrillation (mitral stenosis \>grade 2, mechanical valve, mitral valvuloplasty)
• Patients with a severe comorbid disease
• Expected survival \< 1 year
• Drug addicts or alcoholics
• Patients who cannot read the consent form (illiterates, foreigners, etc.)
• Other patients who are judged by the principal or sub-investigator to be ineligible for participation in this clinical study

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Hui-Nam Pak

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui-Nam Pak

CONTACT

82-2-2228-8459; hnpak@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 17, 2020
• Study Start: December 1, 2020
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 17, 2020

Record last verified: 2020-11

Locations

KR (1)