Left Atrial Isolation by Catheter Ablation in Persistent Atrial Fibrillation With Severe Atrial Fibrosis

NCT05173779 | Unknown

• 1 other identifier: LAICA
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-arm clinical trial evaluating the efficacy and safety of left atrial isolation achieved by catheter ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.

Conditions

Persistent Atrial Fibrillation

Keywords

Persistent Atrial Fibrillation; Severe atrial fibrosis; Left atrial isolation; catheter ablation

Outcome Measures

Primary Outcomes (1)

• Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate

  AF/AFL/AT recurrence is defined as presence of documented AF/AFL/AT episodes of 30 seconds or longer duration

  up to 18 months after enrollment

Secondary Outcomes (4)

• Postoperative AF recurrence rate

  up to 18 months after enrollment

• Postoperative AFL/AT rate

  up to 18 months after enrollment

• Incidence of complications

  up to 18 months after enrollment

• Changes in the diameter of the left atrium and the left ventricular ejection fraction

  up to 18 months after enrollment

Study Arms (1)

Left atrial isolation arm

EXPERIMENTAL

All the enrolled subjects will receive left atrial isolation through catheter ablation.

Procedure: Left atrial isolation by catheter ablation

Interventions

Left atrial isolation by catheter ablation PROCEDURE

Procedure: Right pulmonary vein circumferential isolation + anterior left atrial line (superior mitral annulus to right superior pulmonary vein via the anterior wall) + para-septal line (para-septal mitral annulus to the right inferior pulmonary vein, including right atrial components-especially in and around the proximal coronary sinus) + posterior left atrial line (superior mitral annulus to right superior pulmonary vein via the posterior wall).

Left atrial isolation arm

Eligibility Criteria

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

You may qualify if:

• Aged 18 to 80 years old
• Persistent AF with severe atrial fibrosis and left atrial anterioposterior diameter \> 50mm
• Nonresponse or intolerance to ≥1 antiarrhythmic drug
• CHA2DS2-VASc ≥ 3 and HAS-BLED \< 3

You may not qualify if:

• With uncontrolled congestive heart failure;
• Having significant valvular disease;
• Having moderate-to-severe pulmonary hypertension;
• With myocardial infarction or stroke within 6 months of screening;
• With Significant congenital heart disease;
• Ejection fraction was \<40% measured by echocardiography;
• Allergic to contrast media;
• Contraindication to anticoagulation medications;
• Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
• Left atrial thrombus;
• Having any contraindication to right or left sided heart catheterization

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mu Qin, M.D.

CONTACT

+8613052320103; qinmuae@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, deputy director of cardiology department of Shanghai Chest Hospital

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: December 30, 2021
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 10, 2022

Record last verified: 2022-08