Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to investigate the long-term efficacy and safety of incorporating ganglionated plexus ablation into radiofrequency ablation strategies for persistent atrial fibrillation.
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.
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)
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Standard Ablation Group | No Intervention | Participants in this group will undergo standard ablation treatment, which includes pulmonary vein isolation (PVI) and linear ablation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ganglionated plexus ablation | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 to 365 days post-catheter ablation. |
| Procedure-Related Adverse Events | Occurrence of adverse events related to the procedure during the perioperative or follow-up period, including but not limited to death, myocardial infarction, cardiac tamponade, and stroke. | 1 to 365 days post-catheter ablation. |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial Fibrillation Burden | Quantification of the burden of atrial fibrillation episodes throughout the follow-up period. | 91 to 365 days post-catheter ablation. |
| Radiofrequency Ablation Time | Total duration of radiofrequency ablation during the procedure. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ning Zhou, Ph.D | Contact | +8613871249571 | zhouning@tjh.tjmu.edu.cn |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
|
| Recorded during the catheter ablation procedure. |
| Patient's Postoperative Quality of Life | Assessment using the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire, providing insights into the impact of the procedure on the patient's quality of life. | 1 to 365 days post-catheter ablation. |
| Costs of treatment | Including expenses associated with medical procedures, hospital stay, and additional healthcare resources. The treatment costs will be expressed as a relative ratio, calculated by dividing the treatment cost per patient by the mean treatment cost of the control group. | From patient admission to discharge, averaging a duration of 3 days. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |