Nonvalvular Atrial FibrillationNCT05731882
First in Man Study of Left Atrial Appendage Pulsed Field Ablation Occluder
A study testing E-SeaLA, CardioPulse PFA system in people with Nonvalvular Atrial Fibrillation, run by Hangzhou Dinova EP Technology Co., Ltd at 3 sites in China.
Trial summary
This is the first in man study of E-SeaLATM developed and manufactured by Hangzhou Dinova EP Technology Co., Ltd, which can achieve pulsed field ablation and mechanical closure of the Left Atrial Appendage simultaneously, this study aims to initially verify the safety and efficacy of the device. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nonvalvular Atrial Fibrillation
- What is being tested?
- E-SeaLA, CardioPulse PFA system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesChina
- Study dates
- 17 Jul 2022to 1 Aug 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
- The age of the patient is 18~80 years old;
- patients diagnosed with non-valvular atrial fibrillation (at least 1 episode of atrial fibrillation recorded on ECG or Holter in the 12 months prior to enrollment);
- CHA2DS2-VASC score: male≥ 2, female≥ 3;
- patients are not suitable for long-term oral anticoagulant therapy (any of the following): (1) not suitable for long-term standardized anticoagulation therapy; (2) stroke or embolism still occurs on the basis of long-term standardized anticoagulation therapy; (3) HAS-BLED score≥ 3 points; (4) need to be treated with antiplatelet drugs; (5) unwillingness to undergo long-term anticoagulant therapy;
- Be able to understand the purpose of the study, voluntarily participate in the study, sign the informed consent form by the subject himself or her legal representative, and be willing to complete the follow-up in accordance with the requirements of the program.
Who cannot join
- Atrial fibrillation secondary to electrolyte imbalances, thyroid disease or other reversible factors;
- Left atrial appendage depth < 15mm, left atrial appendage anchor area < 10mm or >33mm;
- Left atrial diameter≥ 65mm;
- Imaging examination shows left atrium or left atrial appendage thrombosis;
- Severe structural heart disease (such as moderate to severe aortic valve, mitral stenosis or regurgitation);
- Left ventricular ejection fraction <35%, or New York College of Cardiology class III or IV;
Show all 22Show fewer
- Refractory hypertension (blood pressure persists > 180/110mmHg after treatment);
- Patients with previous patent foramen ovale closure, atrial septal defect closure or repair;
- Patients with previous left atrial appendage occlusion or left atrial appendage closure;
- Patients with previous valve repair, prosthetic valve implantation or replacement;
- Patients who have implanted devices such as implantable cardioverter defibrillator(ICD), cardiac resynchronization therapy(CRT) or pacemaker or have an implantation plan within 12 months after procedure;
- Patients with clinically symptomatic carotid artery stenosis, or patients who have undergone carotid stenting or carotid endarterectomy in the past 6 months;
- Patients with a history of myocardial infarction in the past 6 months, or who have undergone coronary artery bypass grafting or percutaneous coronary intervention;
- Recorded thromboembolic events (including transient ischemic attack) in the past 30 days;
- Serum creatinine greater than 2 times the upper limit of normal, or history of renal dialysis;
- Acute systemic infection;
- Severe lung disease, pulmonary hypertension or any lung disease involving abnormal blood gases or severe breathing difficulties;
- Presence of wall thrombosis, tumors or other abnormalities that interfere with vascular puncture or catheter operation;
- Female patients who are pregnant, lactating, or unable to use contraception during the study;
- patients have participated in clinical trials of other drugs or devices during the same period;
- patient's life expectancy is less than 12 months;
- Abnormalities or diseases that the investigator believes should be excluded from the scope of enrollment in this study.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Min Tang, professor, dinova_ep@dnamedtech.com
- Recruiting
General Hospital of Northern Theater Command
Shenyang, Liaoning, 110016
Zulu Wang, professor
- Recruiting
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan
Xianqing Wang, professor
About this study
Official title: First in Man Study to Evaluate Safety and Efficacy of Left Atrial Appendage Pulsed Field Ablation Occluder for Simultaneous Pulsed Field Ablation and Mechanical Closure of the Left Atrial Appendage in Patients With Nonvalvular Atrial Fibrillation
This is the first in man study of E-SeaLATM developed and manufactured by Hangzhou Dinova EP Technology Co., Ltd, which can achieve pulsed field ablation and mechanical closure of the Left Atrial Appendage simultaneously, this study aims to initially verify the safety and efficacy of the device.
- Conditions
- Nonvalvular Atrial Fibrillation
- Being tested
- E-SeaLA, CardioPulse PFA system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-SeaLA, CardioPulse PFA systemDevice
First, pulmonary vein isolation(PVI) was performed with the novel hex spline PFA ablation catheter( CardioPulseTM PFA system, Hangzhou Dinova EP Technology Co., Ltd), then, pulsed field ablation and mechanical closure of the left atrial appendage were achieved by E-SeaLATM(Hangzhou Dinova EP Technology Co., Ltd) implantation.
| Study group | Role | What they receive |
|---|---|---|
| Catheter ablation+E-SeaLATM | Experimental | Not described Receives: Device: E-SeaLA, CardioPulse PFA system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success rate
Technical success means that the pulmonary vein and left atrial appendage(LAA) remain electrical isolation 20 minutes after ablation, and the per-device leaks≤ 3 mm after E-SeaLA LAA pulsed field ablation(PFA) occluder implantation.
Measured: immediately after the procedure
The incidence of major adverse events (MAEs) related to devices or procedures 3 months after procedure
MAE includes death, myocardial infarction, stroke or transient ischemic attack (TIA), pulmonary vein stenosis, phrenic nerve palsy, systemic embolism, pericarditis, pericardial effusion/cardiac tamponade, atrial esophageal fistula, severe vascular access complications, device migration, and device embolization.
Measured: within 3 months after procedure
Secondary outcomes (3)
Ablation efficiency including total procedure time, catheter dwell time, total ablation 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), total ablation time (including total PVI ablation time, total LAA ablation time), total X-ray exposure time (the total time of X-ray imaging of the catheter).
Measured: immediately after the procedure
Left atrial appendage closure rate 12 months after procedure
after occlusion device implantation, no forward or reverse blood flow through the occluder confirmed by ultrasound, residual forward or reverse blood flow at the edge of the occluder ≤3mm, peri-device leaks ≥grade 3)
Measured: within 12 months after procedure
Incidence of ischemic stroke within 12 months after procedure (event/patient-year).
Ischemic stroke refers to the loss of neurological function caused by transient ischemic attack, cerebral thrombosis or cerebral embolism caused by the lesions of the brain itself and/or systemic blood circulation disorders leading to cerebral blood supply disorders. Ischemic stroke is defined as a modified Rankin score (mRS) ≥2 90 days after stroke onset.
Measured: within 12 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 posted16 Feb 2023
- Study start17 Jul 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonvalvular 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
- 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
- NCT05731882
- Sponsor's protocol ID
- E-SeaLA FIM 01
- Status last verified
- Jan 2024
- First submitted
- 30 Jan 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First in Man Study to Evaluate Safety and Efficacy of Left Atrial Appendage Pulsed Field Ablation Occluder for Simultaneous Pulsed Field Ablation and Mechanical Closure of the Left Atrial Appendage in Patients With Nonvalvular Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05731882
- Acronym / sponsor ID
- E-SeaLA FIM 01
- Conditions
- Nonvalvular Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hangzhou Dinova EP Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 16 Feb 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 the first in man study of E-SeaLATM developed and manufactured by Hangzhou Dinova EP Technology Co., Ltd, which can achieve pulsed field ablation and mechanical closure of the Left Atrial Appendage simultaneously, this study aims to initially verify the safety and efficacy of the device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Catheter ablation+E-SeaLATM | Experimental | Device: E-SeaLA, CardioPulse PFA system |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The age of the patient is 18~80 years old;
- patients diagnosed with non-valvular atrial fibrillation (at least 1 episode of atrial fibrillation recorded on ECG or Holter in the 12 months prior to enrollment);
- CHA2DS2-VASC score: male≥ 2, female≥ 3;
- patients are not suitable for long-term oral anticoagulant therapy (any of the following): (1) not suitable for long-term standardized anticoagulation therapy; (2) stroke or embolism still occurs on the basis of long-term standardized anticoagulation therapy; (3) HAS-BLED score≥ 3 points; (4) need to be treated with antiplatelet drugs; (5) unwillingness to undergo long-term anticoagulant therapy;
- Be able to understand the purpose of the study, voluntarily participate in the study, sign the informed consent form by the subject himself or her legal representative, and be willing to complete the follow-up in accordance with the requirements of the program.
Key exclusion criteria (22 listed)
- Atrial fibrillation secondary to electrolyte imbalances, thyroid disease or other reversible factors;
- Left atrial appendage depth < 15mm, left atrial appendage anchor area < 10mm or >33mm;
- Left atrial diameter≥ 65mm;
- Imaging examination shows left atrium or left atrial appendage thrombosis;
- Severe structural heart disease (such as moderate to severe aortic valve, mitral stenosis or regurgitation);
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 |
|---|---|---|
| E-SeaLA, CardioPulse PFA systemFirst, pulmonary vein isolation(PVI) was performed with the novel hex spline PFA ablation catheter( CardioPulseTM PFA system, Hangzhou Dinova EP Technology Co., Ltd), then, pulsed field ablation and mechanical closure of the left atrial appendage were achieved by E-SeaLATM(Hangzhou Dinova EP Technology Co., Ltd) implantation. | Device | Catheter ablation+E-SeaLATM |
Primary outcome
Technical success rate
Time frame: immediately after the procedure
Technical success means that the pulmonary vein and left atrial appendage(LAA) remain electrical isolation 20 minutes after ablation, and the per-device leaks≤ 3 mm after E-SeaLA LAA pulsed field ablation(PFA) occluder implantation.
The incidence of major adverse events (MAEs) related to devices or procedures 3 months after procedure
Time frame: within 3 months after procedure
MAE includes death, myocardial infarction, stroke or transient ischemic attack (TIA), pulmonary vein stenosis, phrenic nerve palsy, systemic embolism, pericarditis, pericardial effusion/cardiac tamponade, atrial esophageal fistula, severe vascular access complications, device migration, and device embolization.
3 secondary outcomes
Ablation efficiency including total procedure time, catheter dwell time, total ablation time and total X-ray exposure time
Time frame: immediately after the procedure
Left atrial appendage closure rate 12 months after procedure
Time frame: within 12 months after procedure
Incidence of ischemic stroke within 12 months after procedure (event/patient-year).
Time frame: within 12 months after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Nonvalvular Atrial Fibrillation
RecruitingObservational study
Safety and Effectiveness of Short-Term Single AntiPlatelet Therapy After Left Atrial Appendage Closure With the LAmbre Device in Patients With Nonvalvular Atrial Fibrillation: A Multinational Real-world Registry
Atrial Fibrillation
Recruiting
TEE-Guided Versus CCTA-Guided Preprocedural Imaging for Left Atrial Appendage Closure
Nonvalvular Atrial Fibrillation
RecruitingObservational study
Apixaban Safety and Therapy Adherence in Patients With Atrial Fibrillation
Nonvalvular Atrial Fibrillation
RecruitingPhase 4
Non-antithrombotic Versus. Single Antiplatelet Therapy Following Left Atrial Appendage Closure
Nonvalvular Atrial Fibrillation, Aspirin
Not yet recruiting
The Incidence of New-brain Lesions on Brain MRI and Safety Between Edoxaban and Apixaban in Patients with Stroke and Nonvalvular Atrial Fibrillation
Stroke, 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. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-SeaLA, CardioPulse PFA system in people with Nonvalvular Atrial Fibrillation, run by Hangzhou Dinova EP Technology Co., Ltd at 3 sites 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 5 inclusion and 22 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 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Tang, professor (+86037158680341, dinova_ep@dnaeps.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success rate (time frame: immediately after the procedure). The study lists 2 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 17 Jan 2024.