- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06157437
An Exploratory Study of Focal Pulse Ablation System in the Treatment of Typical Atrial Flutter
November 27, 2023 updated by: Hangzhou Dinova EP Technology Co., Ltd
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 Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
10
Phase
- 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
- Name: Haitao Yang
- Phone Number: +8637158680341
- Email: dinova_ep@dnaeps.com
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Focal pulse ablation system
|
Bidirectional block of the cavo-tricuspid isthmus (CTI) was performed with the novel focal pulse field ablation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
immediately after the procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chronic success
Time Frame: 6 months after procedure
|
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.
|
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
|
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)
|
immediately after the procedure
|
Incidence of device-related major adverse events (MAE) within 7 days after ablation
Time Frame: within 7 days after ablation
|
Device-related MAE includes death, myocardial infarction, pulmonary embolism, stroke /TIA, severe pericardial effusion, and complete atrioventricular block.
|
within 7 days after ablation
|
Incidence of device-related severe adverse events (SAE)
Time Frame: 3 months and 6 months after procedure
|
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.
|
3 months and 6 months after procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
December 1, 2023
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
November 27, 2023
First Submitted That Met QC Criteria
November 27, 2023
First Posted (Estimated)
December 5, 2023
Study Record Updates
Last Update Posted (Estimated)
December 5, 2023
Last Update Submitted That Met QC Criteria
November 27, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- fPFA001
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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