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

Persistent Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05227586
• Other study ID #: RAAFDA
• Status: Completed
• Start date: November 1, 2021
• Est. completion date: January 20, 2022

Study information

• Verified date: January 2022
• Source: Shanghai Chest Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: January 20, 2022
• Est. primary completion date: January 1, 2022
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Hypertrophy
• Persistent Atrial Fibrillation

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Mu Qin	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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