Atrial Fibrillation, PersistentNCT06181578
Ganglion Plexus Ablation in Persistent Atrial Fibrillation
A study testing ganglionated plexus ablation in people with Atrial Fibrillation, Persistent and Ganglionated Plexi, run by Ning Zhou.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Persistent, Ganglionated Plexi, Catheter Ablation
- What is being tested?
- ganglionated plexus ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety Study of Adjunctive Ganglionated Plexus Ablation in Patients With Persistent Atrial Fibrillation: A Randomized Controlled Trial
This study aims to investigate the long-term efficacy and safety of incorporating ganglionated plexus ablation into radiofrequency ablation strategies for persistent atrial fibrillation.
Read the detailed description
- 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.
- 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.
- 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.
- Being tested
- ganglionated plexus ablation
- Keywords
- persistent atrial fibrillation, catheter ablation, ganglionated plexus, high-frequency stimulation, autonomic nervous system, treatment outcome, randomized controlled trial
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ganglionated plexus ablationProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 to 365 days post-catheter ablation.
Secondary outcomes (4)
Atrial Fibrillation Burden
Quantification of the burden of atrial fibrillation episodes throughout the follow-up period.
Measured: 91 to 365 days post-catheter ablation.
Radiofrequency Ablation Time
Total duration of radiofrequency ablation during the procedure.
Measured: 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.
Measured: 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.
Measured: From patient admission to discharge, averaging a duration of 3 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation, PersistentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ning Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ning Zhou, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181578
- Sponsor's protocol ID
- zn101516
- Status last verified
- Dec 2023
- First submitted
- 29 Nov 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of Adjunctive Ganglionated Plexus Ablation in Patients With Persistent Atrial Fibrillation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06181578
- Acronym / sponsor ID
- zn101516
- Keywords
- persistent atrial fibrillation, catheter ablation, ganglionated plexus, high-frequency stimulation, autonomic nervous system, treatment outcome, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ning ZhouUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GP Ablation Group | Experimental | Procedure: ganglionated plexus ablationParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ganglionated plexus ablationThis 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). | Procedure or surgery | GP Ablation Group |
Primary outcome
Recurrence of Atrial Tachycardia and Time to Recurrence
Time frame: 91 to 365 days post-catheter ablation.
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.
Left Atrial Dimensions
Time frame: 1 to 365 days post-catheter ablation.
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.
Left Ventricular Ejection Fraction, LVEF
Time frame: 1 to 365 days post-catheter ablation.
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.
Procedure-Related Adverse Events
Time frame: 1 to 365 days post-catheter ablation.
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.
4 secondary outcomes
Atrial Fibrillation Burden
Time frame: 91 to 365 days post-catheter ablation.
Radiofrequency Ablation Time
Time frame: Recorded during the catheter ablation procedure.
Patient's Postoperative Quality of Life
Time frame: 1 to 365 days post-catheter ablation.
Costs of treatment
Time frame: From patient admission to discharge, averaging a duration of 3 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing ganglionated plexus ablation in people with Atrial Fibrillation, Persistent and Ganglionated Plexi, run by Ning Zhou.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ning Zhou, Ph.D (+8613871249571, zhouning@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of Atrial Tachycardia and Time to Recurrence (time frame: 91 to 365 days post-catheter ablation.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.