Trials Sponsors Conditions Drugs Pricing

Conditions

Atrial Fibrillation, Persistent Catheter Ablation Ganglionated Plexi

Keywords

persistent atrial fibrillationcatheter ablationganglionated plexushigh-frequency stimulationautonomic nervous systemtreatment outcomerandomized controlled trial

Outcome Measures

Primary Outcomes (4)

Recurrence of Atrial Tachycardia and Time to Recurrence
The first occurrence of sustained atrial arrhythmias (excluding atrial premature beats) lasting ≥30 seconds recorded between 91 to 365 days post-catheter ablation, including atrial fibrillation and atrial flutter, etc.
91 to 365 days post-catheter ablation.
Left Atrial Dimensions
Measurement of left atrial size, a key indicator of atrial remodeling, assessed as a primary outcome to evaluate the impact of the intervention on atrial structure.
1 to 365 days post-catheter ablation.
Left Ventricular Ejection Fraction, LVEF
Assessment of left ventricular ejection fraction as a primary outcome measure, providing crucial insights into post-intervention cardiac function and guiding the evaluation of the treatment's efficacy on overall heart performance.

Study Arms (2)

GP Ablation Group

EXPERIMENTAL

Participants in this group will undergo a combined intervention, including standard ablation (pulmonary vein isolation and linear ablation) and additional ablation targeting the autonomic ganglionated plexus (GP).

Procedure: ganglionated plexus ablation

Standard Ablation Group

NO INTERVENTION

Participants in this group will undergo standard ablation treatment, which includes pulmonary vein isolation (PVI) and linear ablation.

Interventions

ganglionated plexus ablationProcedure

This intervention involves the targeted ablation of ganglionated plexus sites, specifically focusing on the left superior ganglionated plexus (LSGP), left inferior ganglionated plexus (LIGP), right anterior ganglionated plexus (RAGP), and right inferior ganglionated plexus (RIGP).

GP Ablation Group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age between 18 and 80 years, regardless of gender.
Patients confirmed by electrocardiogram or clinically diagnosed with persistent atrial fibrillation.

Sponsors & Collaborators

Ning Zhou
Otherlead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Ning Zhou, Ph.D

CONTACT

+8613871249571 zhouning@tjh.tjmu.edu.cn

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Masking Details: This study employs a single-blind design, where the research staff is aware of the patient's group assignment, but the patients themselves are unaware of their group allocation. This approach is implemented to minimize potential subjective bias. The research staff will make efforts to maintain blinding during interactions with the patients to ensure objectivity in data collection and outcome assessment.
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

November 29, 2023

First Posted

December 26, 2023

Study Start

January 1, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Ganglion Plexus Ablation in Persistent Atrial Fibrillation

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Study Arms (2)

GP Ablation Group

Standard Ablation Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Secondary Outcomes (4)

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Study Arms (2)

GP Ablation Group

Standard Ablation Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Secondary Outcomes (4)

You may not qualify if:

Data Sharing

Source record