Persistent Atrial FibrillationNCT07590661
A Study on the Therapeutic Value of Additional Left Atrial Posterior Wall Isolation Guided by Voltage Mapping in Persistent Atrial Fibrillation.
A study testing superior vena cava isolation and Abnormal left atrial substrate in people with Persistent Atrial Fibrillation, run by Hangzhou Dinova EP Technology Co., Ltd at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- superior vena cava isolation and Abnormal left atrial substrate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2026to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older than 18 years.
- 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.
- 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.
Who cannot join
- Atrial fibrillation is secondary to thyroid disease or other reversible factors.
- Evidence of left atrial or left atrial appendage thrombus on imaging examination.
- Rheumatic heart disease or the presence of moderate to severe mitral stenosis or regurgitation.
- Left ventricular ejection fraction <40% or New York Heart Association (NYHA) class III/IV.
- Left atrial anteroposterior diameter >55 mm.
- Unstable angina.
Show all 19Show fewer
- Myocardial infarction (MI), coronary artery bypass grafting (CABG), or percutaneous coronary intervention (PCI) within 3 months prior to enrollment.
- Previous catheter ablation or surgical ablation for atrial fibrillation.
- History of prior left atrial appendage closure, patent foramen ovale closure, atrial septal defect closure, or repair surgery.
- Implantation of a mechanical mitral valve prosthesis or metallic annuloplasty rings.
- Presence of intracardiac thrombus, space-occupying lesions, or other abnormalities that preclude vascular access or catheter manipulation.
- Contraindications to anticoagulation or history of coagulation disorders/abnormal bleeding.
- Active systemic infection.
- Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² or history of renal dialysis.
- Severe hepatic dysfunction.
- Pregnancy or breastfeeding.
- Life expectancy <12 months (e.g., advanced malignancy).
- Current or anticipated participation in other drug or device clinical trials.
- Any other condition or abnormality deemed by the investigator to warrant exclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fuwai Yunnan Hospital
Kunming, Yunnan
Guodong Niu, PhD, +860871-68279999, guodniu@163.com
About this study
Official title: 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.
Read the detailed description
No other detailed description.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- superior vena cava isolation, Abnormal left atrial substrate
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
superior vena cava isolationProcedure or surgery
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.
Abnormal left atrial substrateProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| superior vena cava isolation | Experimental | 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. Receives: Procedure: superior vena cava isolation |
| superior vena cava and left atrial posterior wall isolation | Active comparator | 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. Receives: Procedure: superior vena cava isolation; Procedure: Abnormal left atrial substrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month atrial fibrillation (AF) ablation success rate
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)
Measured: 12 months post-procedure
Secondary outcomes (10)
Acute pulmonary vein ablation success rate and superior vena cava isolation rate.
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).
Measured: Immediately post-procedure
Immediate Success Rate of Left Atrial Posterior Wall Ablation (Abnormal Substrate Group Only)
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.
Measured: Immediately post-procedure
Procedure-related time
Total procedure time, catheter manipulation time, pulse discharge time, total fluoroscopy time.
Measured: Immediately post-procedure
Early recurrence rate of atrial arrhythmia (within the blanking period)
Early recurrence rate of atrial arrhythmia (within the blanking period)
Measured: Within 3 months post-procedure
Incidence of symptomatic and asymptomatic atrial fibrillation events after the end of the blanking period.
Incidence of symptomatic and asymptomatic atrial fibrillation events after the end of the blanking period
Measured: Within 12 months post-procedure
Incidence of repeat ablation after the blanking period
Incidence of repeat ablation after the blanking period
Measured: 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.
Rate of maintenance of pulmonary vein 、left atrial posterior wall and superior vena cava isolation in patients undergoing repeat ablation.
Measured: Within 12 months post-fist procedure.
Improvement in Atrial fibrillation burden.
Evaluate the improvement in postoperative atrial fibrillation burden via ambulatory electrocardiography.
Measured: 3、6 and 12 months post-procedure.
Cardiac function assessment by NYHA
Cardiac function was assessed relative to baseline using the NYHA classification.
Measured: within 12 months post-procedure
The postoperative quality of life was assessed using the Atrial Fibrillation-Specific Quality of Life Scale.
Assess the improvement in health-related quality of life after atrial fibrillation surgery using the Atrial Fibrillation Effect on QualiTy of Life score.
Measured: Within 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start30 Apr 2026 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies 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
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Dinova EP Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590661
- Sponsor's protocol ID
- EP-CP-IIS-010
- Status last verified
- May 2026
- First submitted
- 20 Apr 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- 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 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized Controlled Study on the Therapeutic Value of Additional Left Atrial Posterior Wall Isolation Guided by Voltage Mapping in Persistent Atrial Fibrillation.
- ClinicalTrials.gov ID
- NCT07590661
- Acronym / sponsor ID
- EP-CP-IIS-010
- Conditions
- Persistent Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Hangzhou Dinova EP Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 15 May 2026 (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 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.
Detailed description
No other detailed description.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| superior vena cava isolation | Experimental | Procedure: superior vena cava isolationLeft 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. |
| superior vena cava and left atrial posterior wall isolation | Active comparator | Procedure: superior vena cava isolation, Procedure: Abnormal left atrial substrateLeft 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Older than 18 years.
- 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.
- 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.
Key exclusion criteria (19 listed)
- Atrial fibrillation is secondary to thyroid disease or other reversible factors.
- Evidence of left atrial or left atrial appendage thrombus on imaging examination.
- Rheumatic heart disease or the presence of moderate to severe mitral stenosis or regurgitation.
- Left ventricular ejection fraction <40% or New York Heart Association (NYHA) class III/IV.
- Left atrial anteroposterior diameter >55 mm.
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 |
|---|---|---|
| superior vena cava isolationLeft 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 or surgery | superior vena cava and left atrial posterior wall isolation, superior vena cava isolation |
| Abnormal left atrial substrateLeft 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. | Procedure or surgery | superior vena cava and left atrial posterior wall isolation |
Primary outcome
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)
10 secondary outcomes
Acute pulmonary vein ablation success rate and superior vena cava isolation rate.
Time frame: Immediately post-procedure
Immediate Success Rate of Left Atrial Posterior Wall Ablation (Abnormal Substrate Group Only)
Time frame: Immediately post-procedure
Procedure-related time
Time frame: Immediately post-procedure
Early recurrence rate of atrial arrhythmia (within the blanking period)
Time frame: 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 repeat ablation after the blanking period
Time frame: 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.
Improvement in Atrial fibrillation burden.
Time frame: 3、6 and 12 months post-procedure.
Cardiac function assessment by NYHA
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
Related trials for Persistent Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With TRUPULSE™ Generator in Persistent Atrial Fibrillation
Atrial Fibrillation
Not yet recruitingPhase 4
Sacubitril/Valsartan vs Standard Treatment for Preventing Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients With Without Hypertension
Atrial Fibrillation (Persistent), Catheter Ablation
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing superior vena cava isolation and Abnormal left atrial substrate in people with Persistent Atrial Fibrillation, run by Hangzhou Dinova EP Technology Co., Ltd at 1 site in China.
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 3 inclusion and 19 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: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GUODONG NIU (+86 0871-68279999, guodniu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-month atrial fibrillation (AF) ablation success rate (time frame: 12 months post-procedure). 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 15 May 2026.