Adjunctive Right Atrial Ablation for Persistent Atrial Fibrillation With Right Atrial Enlargement

This is retrospective cohort study testing whether patients with persistent atrial fibrillation and right atrial enlargement may benefit from adjunctive right atrial ablation.

Study Overview

• Status: Completed
• Conditions: Persistent Atrial Fibrillation; Right Atrial Enlargement
• Intervention / Treatment: Procedure: Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + left atrial driver ablation + right atrial driver ablation; Procedure: Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + left atrial driver ablation

Detailed Description

This is retrospective cohort study testing whether patients with persistent atrial fibrillation and right atrial enlargement may benefit from adjunctive RA ablation.

We enrolled 65 patients with persistent atrial fibrillation and right atrial enlargement received adjunctive right atrial ablation. These patients were 1:2 match with 130 patients received left atrial ablation only. Atrial fibrillation recurrence rate and other paremeters were analyzed to evaluate the efficacy of adjunctive right atrial ablation in this subset of patients.

• Study Type: Observational
• Enrollment (Actual): 195

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200030
    • Mu Qin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population enrolled were patients with persistent atrial fibrillation and right atrial enlargement received catheter ablation for the first time in our institution.

Patients with a history of catheter ablation, valvular heart disease, hypertrophic or dilated cardiomyopathy and unavailable of follow-up data were excluded

Description

Inclusion Criteria:

1. Aged 18 to 80 years old;
2. Persistent AF with right atrial enlargement;
3. Nonresponse or intolerance to ≥1 antiarrhythmic drug.

Exclusion Criteria:

1. History of catheter ablation;
2. valvular heart disease;
3. hypertrophic cardiomyopathy or dilated cardiomyopathy;
4. Without follow-up data

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LA + RA ablation; Patients with persistent atrial fibrillation and right atrial enlargement received adjunctive right atrial ablation when left atrial ablation did not terminate atrial fibrillation.	Procedure: Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + left atrial driver ablation + right atrial driver ablation; Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with bi-atrial mapping , left atrial driver ablation and right atrial driver ablation.
LA ablation only; Patients with persistent atrial fibrillation and right atrial enlargement received left atrial ablation only	Procedure: Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + left atrial driver ablation; 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 left atrial driver ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
atrial fibrillation (AF) recurrence rate	AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration	at 12 months post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at 12 months post procedure

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 20, 2022

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: January 26, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2022
• Last Update Submitted That Met QC Criteria: January 26, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Right atrium
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Arrhythmias, Cardiac; Atrial Fibrillation; Hypertrophy
• Other Study ID Numbers: RAAFDA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No