A Study on the Therapeutic Value of Additional Left Atrial Posterior Wall Isolation Guided by Voltage Mapping in Persistent Atrial Fibrillation.

May 12, 2026 updated by: Hangzhou Dinova EP Technology Co., Ltd

Prospective, Multicenter, Randomized Controlled Study on the Therapeutic Value of Additional Left Atrial Posterior Wall Isolation Guided by Voltage Mapping in Persistent Atrial Fibrillation.

This prospective, multicenter, randomized controlled study was designed to investigate the feasibility, efficacy and safety of pulsed field ablation (PFA) strategies for persistent atrial fibrillation. For patients with persistent atrial fibrillation and normal left atrial substrate, pulmonary vein isolation combined with superior vena cava isolation will be performed. For those with abnormal left atrial substrate, two strategies will be adopted: pulmonary vein isolation plus superior vena cava isolation, and pulmonary vein isolation combined with superior vena cava isolation and left atrial posterior wall isolation. Long-term follow-up will be conducted to observe the long-term clinical outcomes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

No other detailed description.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Yunnan
      • Kunming, Yunnan, China
        • Fuwai Yunnan Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Older than 18 years.
  2. Diagnosed as persistent atrial fibrillation (AF); Definition: At least one episode of persistent AF was recorded on dynamic electrocardiogram (ECG) data within 12 months prior to enrollment, or other clinical evidence supporting persistent AF episodes lasting more than 7 days.
  3. Subjects are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to complete the follow-up according to the requirements of the program.

Exclusion Criteria:

  1. Atrial fibrillation is secondary to thyroid disease or other reversible factors.
  2. Evidence of left atrial or left atrial appendage thrombus on imaging examination.
  3. Rheumatic heart disease or the presence of moderate to severe mitral stenosis or regurgitation.
  4. Left ventricular ejection fraction <40% or New York Heart Association (NYHA) class III/IV.
  5. Left atrial anteroposterior diameter >55 mm.
  6. Unstable angina.
  7. Myocardial infarction (MI), coronary artery bypass grafting (CABG), or percutaneous coronary intervention (PCI) within 3 months prior to enrollment.
  8. Previous catheter ablation or surgical ablation for atrial fibrillation.
  9. History of prior left atrial appendage closure, patent foramen ovale closure, atrial septal defect closure, or repair surgery.
  10. Implantation of a mechanical mitral valve prosthesis or metallic annuloplasty rings.
  11. Presence of intracardiac thrombus, space-occupying lesions, or other abnormalities that preclude vascular access or catheter manipulation.
  12. Contraindications to anticoagulation or history of coagulation disorders/abnormal bleeding.
  13. Active systemic infection.
  14. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² or history of renal dialysis.
  15. Severe hepatic dysfunction.
  16. Pregnancy or breastfeeding.
  17. Life expectancy <12 months (e.g., advanced malignancy).
  18. Current or anticipated participation in other drug or device clinical trials.
  19. Any other condition or abnormality deemed by the investigator to warrant exclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: superior vena cava isolation
Left atrial substrate mapping is performed after pulmonary vein ablation. For patients with abnormal left atrial substrate, superior vena cava isolation and left atrial posterior wall isolation will be conducted in the experimental group.
Procedure: superior vena cava isolation
Left atrial substrate mapping is performed after pulmonary vein ablation. For patients with abnormal left atrial substrate, superior vena cava isolation isolation will be conducted in the experimental group.
Active Comparator: superior vena cava and left atrial posterior wall isolation
Left atrial substrate mapping is performed following pulmonary vein ablation. For patients with abnormal left atrial substrate, superior vena cava and left atrial posterior wall isolation will be carried out in the control group.
Procedure: superior vena cava isolation
Left atrial substrate mapping is performed after pulmonary vein ablation. For patients with abnormal left atrial substrate, superior vena cava isolation isolation will be conducted in the experimental group.
Procedure: Abnormal left atrial substrate
Left atrial substrate mapping is performed following pulmonary vein ablation. For patients with abnormal left atrial substrate, superior vena cava isolation will be carried out in the control group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
12-month atrial fibrillation (AF) ablation success rate
Time Frame: 12 months post-procedure
Defined as the absence of AF, atrial flutter (AFL), or atrial tachycardia (AT) episodes ≥30 seconds on dynamic electrocardiogram (ECG) monitoring after the blanking period (90 days post-catheter ablation)
12 months post-procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acute pulmonary vein ablation success rate and superior vena cava isolation rate.
Time Frame: Immediately post-procedure
Twenty minutes after completion of ablation, under three-dimensional electroanatomical mapping, the ablated area presents as an electrically silent region (voltage < 0.1 mV). Alternatively, a circular mapping catheter or ablation catheter is positioned within the ablation line: (1) disappearance of intracatheter potentials within the ablation line (entrance block); (2) no local potential capture during pacing of the pulmonary veins and superior vena cava, or local potential capture without subsequent conduction exit (exit block).
Immediately post-procedure
Immediate Success Rate of Left Atrial Posterior Wall Ablation (Abnormal Substrate Group Only)
Time Frame: Immediately post-procedure
Twenty minutes after completion of ablation, the ablated area presented as an electrically silent zone (voltage < 0.1 mV) under three-dimensional electroanatomic mapping; no local potential capture was achieved during posterior wall pacing.
Immediately post-procedure
Procedure-related time
Time Frame: Immediately post-procedure
Total procedure time, catheter manipulation time, pulse discharge time, total fluoroscopy time.
Immediately post-procedure
Early recurrence rate of atrial arrhythmia (within the blanking period)
Time Frame: Within 3 months post-procedure
Early recurrence rate of atrial arrhythmia (within the blanking period)
Within 3 months post-procedure
Incidence of symptomatic and asymptomatic atrial fibrillation events after the end of the blanking period.
Time Frame: Within 12 months post-procedure
Incidence of symptomatic and asymptomatic atrial fibrillation events after the end of the blanking period
Within 12 months post-procedure
Incidence of repeat ablation after the blanking period
Time Frame: Within 12 months post-procedure
Incidence of repeat ablation after the blanking period
Within 12 months post-procedure
Rate of maintenance of pulmonary vein 、left atrial posterior wall and superior vena cava isolation in patients undergoing repeat ablation.
Time Frame: Within 12 months post-fist procedure.
Rate of maintenance of pulmonary vein 、left atrial posterior wall and superior vena cava isolation in patients undergoing repeat ablation.
Within 12 months post-fist procedure.
Improvement in Atrial fibrillation burden.
Time Frame: 3、6 and 12 months post-procedure.
Evaluate the improvement in postoperative atrial fibrillation burden via ambulatory electrocardiography.
3、6 and 12 months post-procedure.
Cardiac function assessment by NYHA
Time Frame: within 12 months post-procedure
Cardiac function was assessed relative to baseline using the NYHA classification.
within 12 months post-procedure
The postoperative quality of life was assessed using the Atrial Fibrillation-Specific Quality of Life Scale.
Time Frame: Within 12 months post-procedure
Assess the improvement in health-related quality of life after atrial fibrillation surgery using the Atrial Fibrillation Effect on QualiTy of Life score.
Within 12 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hangzhou Dinova EP Technology Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EP-CP-IIS-010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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