Typical Atrial FlutterNCT06157437
An Exploratory Study of Focal Pulse Ablation System in the Treatment of Atrial Arrhythmia
A study testing Focal Pulse field Ablation in people with Typical Atrial Flutter and Atrial Fibrillation (AF), run by Hangzhou Dinova EP Technology Co., Ltd at 1 site in China.
Trial summary
This is a prospective, single-group clinical study. The objective is to evaluate the safety and efficacy of focal pulse ablation system in the treatment of typical atrial flutter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Typical Atrial Flutter, Atrial Fibrillation (AF)
- What is being tested?
- Focal Pulse field Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 30 Jun 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged at least 18;
- Subjects with at least one typical atrial flutter attack recorded by ECG or holter in the 180 days prior to enrollment, and the ECG of other hospitals could be accepted;
- 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
- Any prior cavo-tricuspid isthmus ablation;
- Unstable angina;
- Atrial flutter secondary to electrolyte disorder, thyroid disease or other reversible causes;
- Myocardial infarction or coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within the prior three months;
- At baseline, New York College of Cardiology (NYHA) heart function grades III and IV;
- Implantable devices such as ICDs, CRTS and pacemakers in the body;
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- Atrial or ventricular tumors, blood clots, thrombus, or known clotting disorders were recorded within the prior 90 days;
- Severe structural heart disease, including tricuspid stenosis, tricuspid malformation, or other congenital heart disease that prevents ablation surgery;
- Previously received tricuspid metal valve replacement;
- Thromboembolic events (including transient ischemic attacks) within the past 6 months;
- Mural thrombosis, tumor, or other abnormality that interferes with vascular puncture or catheter operation;
- Severe lung disease, pulmonary hypertension or any lung disease involving abnormal blood gas or severe breathing difficulties;
- Anticoagulation contraindications and a history of blood clotting or abnormal bleeding;
- Acute systemic infection;
- Serum creatinine greater than twice the upper limit of normal, or any history of renal dialysis;
- Women who are pregnant or breastfeeding or who cannot use contraception during the study period;
- Enrollment in another clinical trial evaluating other devices or drugs during the same period;
- Life expectancy less than 12 months (e.g. advanced malignancy);
- Abnormalities or diseases considered by the investigator to be excluded from inclusion in this study.
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
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Ming Tang, +8613810665178, doctortangmin@sina.com
About this study
This is a prospective, single-group clinical study. The objective is to evaluate the safety and efficacy of focal pulse ablation system in the treatment of typical atrial flutter.
- Conditions
- Typical Atrial Flutter, Atrial Fibrillation (AF)
- Being tested
- Focal Pulse field Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal Pulse field AblationDevice
Bidirectional block of the cavo-tricuspid isthmus (CTI) was performed with the novel focal pulse field ablation.
| Study group | Role | What they receive |
|---|---|---|
| Focal pulse ablation system | Experimental | Not described Receives: Device: Focal Pulse field Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute procedural success
Acute procedural success is defined as the creation of bidirectional conduction block across the cavo-tricuspid isthmus immediately and 30 minutes after ablation.
Measured: immediately after the procedure
Secondary outcomes (4)
Chronic success
Chronic success is defined as the absence of recurrent atrial flutter at 6 months post-ablation according to electrocardiogram data, including electrocardiogram, 24-hour Holter.
Measured: 6 months after procedure
Ablation efficiency including total procedure time, catheter dwell time, pulse discharge time and total X-ray exposure time
Total procedure time (defined as the total time from initial femoral venipuncture to final catheter removal), catheter dwell time (time between the pulsed field ablation catheter entering the left atrium and its withdrawal from the left atrium), pulse discharge time (The total time of delivering pulse energy through the pulsed field ablation catheter, single ablation time ablation times), total X-ray exposure time (the total time of X-ray imaging of the catheter)
Measured: immediately after the procedure
Incidence of device-related major adverse events (MAE) within 7 days after ablation
Device-related MAE includes death, myocardial infarction, pulmonary embolism, stroke /TIA, severe pericardial effusion, and complete atrioventricular block.
Measured: within 7 days after ablation
Incidence of device-related severe adverse events (SAE)
Device-related SAE refers to a device-related event that occurs during the clinical trial that results in mortality or serious deterioration in patient health, including a fatal illness or injury, a permanent defect in body structure or body function, or an event that requires medical or surgical intervention to avoid one or more permanent defects in body structure or body function.
Measured: 3 months and 6 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start1 Dec 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Typical Atrial FlutterStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT06157437
- Sponsor's protocol ID
- fPFA001
- Status last verified
- Feb 2025
- First submitted
- 27 Nov 2023
- Last updated
- 11 Feb 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 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Focal Pulse Ablation System in the Treatment of Atrial Arrhythmia
- ClinicalTrials.gov ID
- NCT06157437
- Acronym / sponsor ID
- fPFA001
- Conditions
- Typical Atrial Flutter, Atrial Fibrillation (AF)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hangzhou Dinova EP Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 5 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 is a prospective, single-group clinical study. The objective is to evaluate the safety and efficacy of focal pulse ablation system in the treatment of typical atrial flutter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focal pulse ablation system | Experimental | Device: Focal Pulse field Ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects aged at least 18;
- Subjects with at least one typical atrial flutter attack recorded by ECG or holter in the 180 days prior to enrollment, and the ECG of other hospitals could be accepted;
- 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)
- Any prior cavo-tricuspid isthmus ablation;
- Unstable angina;
- Atrial flutter secondary to electrolyte disorder, thyroid disease or other reversible causes;
- Myocardial infarction or coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within the prior three months;
- At baseline, New York College of Cardiology (NYHA) heart function grades III and IV;
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 |
|---|---|---|
| Focal Pulse field AblationBidirectional block of the cavo-tricuspid isthmus (CTI) was performed with the novel focal pulse field ablation. | Device | Focal pulse ablation system |
Primary outcome
Acute procedural success
Time frame: immediately after the procedure
Acute procedural success is defined as the creation of bidirectional conduction block across the cavo-tricuspid isthmus immediately and 30 minutes after ablation.
4 secondary outcomes
Chronic success
Time frame: 6 months after procedure
Ablation efficiency including total procedure time, catheter dwell time, pulse discharge time and total X-ray exposure time
Time frame: immediately after the procedure
Incidence of device-related major adverse events (MAE) within 7 days after ablation
Time frame: within 7 days after ablation
Incidence of device-related severe adverse events (SAE)
Time frame: 3 months and 6 months after 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 11 Feb 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focal Pulse field Ablation in people with Typical Atrial Flutter and 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 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: looking for participants now, as of the sponsor's last update on 11 Feb 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 Haitao Yang (+8637158680341, dinova_ep@dnaeps.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute procedural success (time frame: immediately after the 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 11 Feb 2025.