Atrial Fibrillation (AF)COMBINATION 2PNCT07036965
Comparison of Different Pulsed Field Ablation Catheters in Atrial Fibrillation
A study testing CardiPulse and FaraPulse in people with Atrial Fibrillation (AF), run by Hangzhou Dinova EP Technology Co., Ltd at 1 site in China.
Trial summary
Pulsed field energy ablation, a non-thermal ablation modality, can potentially reduce post-ablation tissue edema. Previous studies have confirmed the feasibility and safety of combined pulsed field ablation (PFA) and left atrial appendage closure (LAAC) as a one-stop treatment, with few reports of post-ablation tissue… Read more about this study
- Who is it for?
- Ages 118 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- CardiPulse and FaraPulse
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2025to 30 Jun 2031
- 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 118 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Older than 18 years.
- Diagnosed with drug-refractory, symptomatic atrial fibrillation.
- The patient has a high risk of stroke (CHA2DS2-VA score ≥ 2).
- Have a situation of:
- requires oral anticoagulation therapy
- high bleeding risk (HAS-BLED score ≥ 3) that unsuitable for or unwilling to undergo long-term oral anticoagulation therapy.
- 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
- History of persistent atrial fibrillation >1 year.
- Atrial fibrillation was secondary to thyroid disease or other reversible reasons.
- Left atrial anteroposterior diameter >50 mm.
- Evidence of left atrial or left atrial appendage thrombus on imaging examination.
- Concurrent other arrhythmias required for catheter ablation (e.g., atrioventricular reentrant tachycardia, atrioventricular nodal reentrant tachycardia, pre-excitation syndrome) prior to enrollment.
- Rheumatic heart disease.
Show all 19Show fewer
- Left ventricular ejection fraction <40% or New York Heart Association (NYHA) class III/IV.
- Unstable angina.
- Myocardial infarction (MI), coronary artery bypass grafting (CABG), or percutaneous coronary intervention (PCI) within 3 months prior to enrollment.
- 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.
- 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, 1 recruiting
- Recruiting
Ningbo First Hospital
Hangzhou
Huimin Chu, Dorctor, +86 574-87085211, epnbheart@163.com
About this study
Official title: Comparison of Different Pulsed Field Ablation Catheters Combined With Stroke Prevention in High Stroke Risk·Atrial Fibrillation: A Prospective, Multicenter, Randomized Controlled Trial
Pulsed field energy ablation, a non-thermal ablation modality, can potentially reduce post-ablation tissue edema. Previous studies have confirmed the feasibility and safety of combined pulsed field ablation (PFA) and left atrial appendage closure (LAAC) as a one-stop treatment, with few reports of post-ablation tissue edema. However, during PFA procedures, the presence of metallic components in the ablation site (e.g., occluder frames, metallic valves) may lead to arcing during energy delivery, compromising procedural safety. Therefore, when performing PFA+LAAC as a one-stop procedure, a "ablation-first" strategy is recommended. Due to the influence of parameters such as voltage, pulse width, and number of cycles on pulsed field energy characteristics, significant variability in ablation depth and area may exist between different PFA devices. To date, no large-scale clinical studies have compared the efficacy and safety of different PFA systems. Accordingly, this study will conduct a prospective, multicenter, randomized controlled trial to compare the effectiveness and safety of domestic versus imported pulsed field ablation catheters in the treatment of patients with atrial fibrillation.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- CardiPulse, FaraPulse
- Keywords
- atrial fibrillation, pulsed field ablation, LAAC
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardiPulseDevice
abc
FaraPulseDevice
bcd
| Study group | Role | What they receive |
|---|---|---|
| CardiPulse Group | Experimental | Patients accept atrial fibrillation ablation with CardiPulse pulsed field ablation catheter Receives: Device: CardiPulse |
| FaraPulse Group | Active comparator | Patients accept atrial fibrillation ablation with FaraPulse pulsed field ablation catheter Receives: Device: FaraPulse |
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
Defined as maintained bidirectional block across the ablation line 20 minutes after ablation
Measured: Immediately post-procedure
Incidence of major adverse events (MAEs) related to the device
Including stroke/transient ischemic attack (TIA), pulmonary vein stenosis, phrenic nerve paralysis, systemic embolism, pericarditis, pericardial effusion/cardiac tamponade, atrioesophageal fistula, myocardial infarction, or severe vascular access complications
Measured: Within 7 days post-procedure
Incidence of repeat ablation
Summary ncidence of repeat ablation after the blanking period
Measured: Within 12 months post-procedure
AF burden
Record AF burden at 6 and 12 months post-procedure
Measured: 6 and 12 months post-procedure
Incidence of cardiovascular MAEs
Incidence of thromboembolic events (including stroke/TIA), cardiovascular-related rehospitalization, or cardiovascular mortality within 12 months post-procedure
Measured: Within 12 months post-procedure
Technical success rate of LAAC
Defined as successful LAA occlusion without residual shunt >3 mm and no device-related complications
Measured: Immediately post-procedure
LAA closure rate
Defined as imaging-confirmed residual shunt ≤3 mm at the device edges.
Measured: 3 and 6 months post-procedure
Incidence of new residual shunt
Defined as any increase in residual shunt (post-procedure shunt volume - intraoperative shunt volume >0 mm)
Measured: 3 and 6 months post-procedure
Incidence of device-related thrombus
Record device-related thrombus events during follow-up
Measured: Within 12 months post-procedure.
Discontinuation rate of anticoagulants and antiarrhythmic medications
Record drugs history during follow up
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 posted25 Jun 2025
- Study start30 Jun 2025 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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
- 292 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
- NCT07036965
- Sponsor's protocol ID
- CP-IIS-007
- Acronym
- COMBINATION 2P
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 25 Jun 2025
- 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 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Pulsed Field Ablation Catheters Combined With Stroke Prevention in High Stroke Risk·Atrial Fibrillation: A Prospective, Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07036965
- Acronym / sponsor ID
- COMBINATION 2P / CP-IIS-007
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- atrial fibrillation, pulsed field ablation, LAAC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 292 participants (estimated)
- Lead sponsor
- Hangzhou Dinova EP Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 25 Jun 2025 (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.
Pulsed field energy ablation, a non-thermal ablation modality, can potentially reduce post-ablation tissue edema. Previous studies have confirmed the feasibility and safety of combined pulsed field ablation (PFA) and left atrial appendage closure (LAAC) as a one-stop treatment, with few reports of post-ablation tissue edema. However, during PFA procedures, the presence of metallic components in the ablation site (e.g., occluder frames, metallic valves) may lead to arcing during energy delivery, compromising procedural safety. Therefore, when performing PFA+LAAC as a one-stop procedure, a "ablation-first" strategy is recommended. Due to the influence of parameters such as voltage, pulse width, and number of cycles on pulsed field energy characteristics, significant variability in ablation depth and area may exist between different PFA devices. To date, no large-scale clinical studies have compared the efficacy and safety of different PFA systems. Accordingly, this study will conduct a prospective, multicenter, randomized controlled trial to compare the effectiveness and safety of domestic versus imported pulsed field ablation catheters in the treatment of patients with atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CardiPulse Group | Experimental | Device: CardiPulsePatients accept atrial fibrillation ablation with CardiPulse pulsed field ablation catheter |
| FaraPulse Group | Active comparator | Device: FaraPulsePatients accept atrial fibrillation ablation with FaraPulse pulsed field ablation catheter |
Who may qualify
- Ages
- 118 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Older than 18 years.
- Diagnosed with drug-refractory, symptomatic atrial fibrillation.
- The patient has a high risk of stroke (CHA2DS2-VA score ≥ 2).
- Have a situation of:
- 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)
- History of persistent atrial fibrillation >1 year.
- Atrial fibrillation was secondary to thyroid disease or other reversible reasons.
- Left atrial anteroposterior diameter >50 mm.
- Evidence of left atrial or left atrial appendage thrombus on imaging examination.
- Concurrent other arrhythmias required for catheter ablation (e.g., atrioventricular reentrant tachycardia, atrioventricular nodal reentrant tachycardia, pre-excitation syndrome) prior to enrollment.
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 |
|---|---|---|
| CardiPulseabc | Device | CardiPulse Group |
| FaraPulsebcd | Device | FaraPulse Group |
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
Time frame: Immediately post-procedure
Incidence of major adverse events (MAEs) related to the device
Time frame: Within 7 days post-procedure
Incidence of repeat ablation
Time frame: Within 12 months post-procedure
AF burden
Time frame: 6 and 12 months post-procedure
Incidence of cardiovascular MAEs
Time frame: Within 12 months post-procedure
Technical success rate of LAAC
Time frame: Immediately post-procedure
LAA closure rate
Time frame: 3 and 6 months post-procedure
Incidence of new residual shunt
Time frame: 3 and 6 months post-procedure
Incidence of device-related thrombus
Time frame: Within 12 months post-procedure.
Discontinuation rate of anticoagulants and antiarrhythmic medications
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 25 Jun 2025.
- Individual participant dataSharing planned: No
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ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
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 CardiPulse and FaraPulse in people with Atrial Fibrillation (AF), 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 7 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: looking for participants now, as of the sponsor's last update on 25 Jun 2025. 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 Huimin Chu, Dorctor (+86 574-87085211, epnbheart@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 25 Jun 2025.