Driver Ablation of Persistent Atrial Fibrillation With Severe Atrial Fibrosis.

NCT05085912 | Unknown

• 1 other identifier: DAAF
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an open label, randomized parallel control clinical trial, to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation with severe atrial fibrosis, and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation with severe atrial fibrosis.

Conditions

Persistent Atrial Fibrillation

Keywords

persistent atrial fibrillation; severe atrial fibrosis; driver ablation

Outcome Measures

Primary Outcomes (2)

• 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 12 months after ablation

• Intraoperative AF termination rate

  AF termination is defined as conversion to sinus rhythm or stable AFL/AT.

  through ablation completion, an average of 3 hours

Secondary Outcomes (5)

• Postoperative AF recurrence rate

  up to 12 months after ablation

• Postoperative AFL/AT rate

  up to 12 months after ablation

• Incidence of complications

  up to 12 months after ablation

• Changes in the diameter of the left atrium

  up to 12 months after ablation

• Changes in the left ventricular ejection fraction

  up to 12 months after ablation

Study Arms (3)

Group A

EXPERIMENTAL

Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation

Procedure: Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation

Group B

ACTIVE COMPARATOR

Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation

Procedure: Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation

Group C

ACTIVE COMPARATOR

Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion

Procedure: Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion

Interventions

Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation PROCEDURE

Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with bi-atrial mapping and driver ablation.

Group A

Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation PROCEDURE

Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with posterior wall box isolation.

Group B

Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion PROCEDURE

Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with vein of Marshall ethanol infusion.

Group C

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;
• Nonresponse or intolerance to ≥1 antiarrhythmic drug.

You may not qualify if:

• With uncontrolled congestive heart failure;
• Having significant valvular disease;
• 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 (LA) thrombus;
• Having any contraindication to right or left sided heart catheterization; 11. Previous atrial fibrillation ablation;
• \. Presence of an implanted cardioverter-defibrillator; 13. Previous history of cardiac surgery; 14. Poor general health; 15. Life expectancy less than 6 months.

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, deputy director of cardiology department of Shanghai Chest Hospita

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 20, 2021
• Study Start: November 1, 2021
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: October 20, 2021

Record last verified: 2021-10