Clinical trial NCT06181578: Ganglion Plexus Ablation in Persistent Atrial Fibrillation
Official title: Efficacy and Safety Study of Adjunctive Ganglionated Plexus Ablation in Patients With Persistent Atrial Fibrillation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation, Persistent
Ganglionated Plexi
Catheter Ablation
Keywords: persistent atrial fibrillation
catheter ablation
ganglionated plexus
high-frequency stimulation
autonomic nervous system
treatment outcome
randomized controlled trial
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the long-term efficacy and safety of incorporating ganglionated plexus ablation into radiofrequency ablation strategies for persistent atrial fibrillation.

Detailed description: 1. Study Design:

   The study employs a parallel-group design with a 1:1 randomization ratio. Eligible patients meeting the specified criteria will be randomly assigned to either the conventional ablation group (pulmonary vein isolation + linear ablation) or the intervention group receiving additional ganglionated plexus ablation.
2. Intervention:

   Control Group: Conventional ablation (pulmonary vein isolation + linear ablation) Intervention Group: Conventional ablation + ganglionated plexus ablation (left superior, left inferior, right anterior, and right inferior ganglionated plexi)
3. Randomization and Sequence Generation:

To ensure randomness and comparability, a computer-generated random sequence will be utilized. Specific steps include:

* Pre-matching the numbers 1-50 with 50 random numbers.
* Allocating each random number equally to 2 groups, with the assigned numbers representing the order of patient enrollment.
* Performing the above steps using R.

  5. Data Collection: Baseline data, including demographics, medical history, and laboratory parameters, will be collected at the start. Intraoperative electrophysiological and ablation-related parameters, as well as postoperative adverse events, will be documented. Follow-up data will include postoperative survival, quality of life (assessed using the Atrial Fibrillation Effect on Quality-of-Life questionnaire), dynamic electrocardiogram recordings, recurrence of atrial fibrillation or other arrhythmias, rehospitalization for arrhythmia, and medication usage.

  6. Endpoints:
* Primary Endpoints:

Recurrence of atrial tachyarrhythmias; Echocardiographic parameters; Procedure-related adverse events

* Secondary Endpoints:

Atrial fibrillation burden; Radiofrequency ablation time; Patient postoperative quality of life; Healthcare resource utilization

The trial's initiation date will be documented, and all procedures will be conducted at the Cardiovascular Department of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. The study will adhere to ethical guidelines and regulations, and informed consent will be obtained from all participants.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 80 years, regardless of gender.
* Patients confirmed by electrocardiogram or clinically diagnosed with persistent atrial fibrillation.
* Individuals scheduled to undergo atrial fibrillation catheter ablation.
* Willing to participate in the study and voluntarily sign the informed consent form.

Exclusion Criteria:

* Patients with a history of prior atrial fibrillation ablation surgery.
* Left ventricular ejection fraction (LVEF) less than 35%.
* Left atrial anterior-posterior diameter greater than 50mm on echocardiography.
* Presence of contraindications for atrial fibrillation ablation, such as the presence of clear thrombus in the left atrium detected preoperatively.
* Patients with second-degree (Type II) or third-degree atrioventricular block.
* Individuals with significant congenital heart defects (such as atrial septal defects or severe pulmonary vein stenosis, excluding unclosed foramen ovale).
* Patients with implanted artificial valves.
* Diagnosed with hypertrophic cardiomyopathy, chronic obstructive pulmonary disease, or myxoma.
* Untreated or uncontrolled hyperthyroidism or hypothyroidism.
* Patients with active systemic infections.
* Individuals with a significant bleeding tendency or those undergoing active blood dialysis due to renal failure.
* Patients who have experienced myocardial infarction within the last 3 months or undergone any cardiac intervention/open-heart surgery.
* Presence of clear contraindications for interventional procedures, as determined by the investigator.
* Pregnant or lactating women, or those planning pregnancy during the study period.
* Participation in other drug or medical device clinical trials within the last 3 months.
* Patients deemed unsuitable for participation in this clinical trial by the investigator.

Primary outcomes:
measure: Recurrence of Atrial Tachycardia and Time to Recurrence
timeFrame: 91 to 365 days post-catheter ablation.
measure: Left Atrial Dimensions
timeFrame: 1 to 365 days post-catheter ablation.
measure: Left Ventricular Ejection Fraction, LVEF
timeFrame: 1 to 365 days post-catheter ablation.
measure: Procedure-Related Adverse Events
timeFrame: 1 to 365 days post-catheter ablation.
Secondary outcomes:
measure: Atrial Fibrillation Burden
timeFrame: 91 to 365 days post-catheter ablation.
measure: Radiofrequency Ablation Time
timeFrame: Recorded during the catheter ablation procedure.
measure: Patient's Postoperative Quality of Life
timeFrame: 1 to 365 days post-catheter ablation.
measure: Costs of treatment
timeFrame: From patient admission to discharge, averaging a duration of 3 days.
Other outcomes:
Locations:
Study officials:
References: