A Multicenter, Open, Single Design, Researcher-led, Phase 1 Exploratory Study to Evaluate the Safety and Efficacy of Vein of Marshall RF Ablation Using TIRA(VA510 and Other 3 Types) in Patients With Persistent Atrial Fibrillation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Persistent Atrial Fibrillation
- Sponsor
- Tau-MEDICAL Co., Ltd.
- Enrollment
- 4
- Locations
- 2
- Primary Endpoint
- Changes of electrical signals around the Marshall vein(2)
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
The goal of this clinical trial is to evaluate the initial safety and effectiveness of an investigational medical device.
Electrode catheter ablation of the Marshall vein is performed using TIRA, a clinical trial medical device for patients with persistent atrial fibrillation,
Detailed Description
By analyzing the collected data, the initial safety and efficacy of the electrode catheter ablation effect of the clinical trial medical device is evaluated. After the clinical trial, the initial safety and efficacy of the electrode catheter ablation are evaluated by analyzing the changes in electrical signals before and after the procedure and by monitoring patients.
Investigators
Min Soo Cho
associate professor
Asan Medical Center
Eligibility Criteria
Inclusion Criteria
- •Patients who meet all of the following criteria will be included.
- •Men and women who are at least 20 years of age (80 years of age or older for geriatric patients).
- •Patients requiring electrode ablation because of persistent arrhythmia despite use of antiarrhythmic drugs for more than 6 weeks
- •Patients diagnosed with persistent atrial fibrillation after 2 consecutive electrocardiograms or 24-hour Holter test performed at least 1 week apart.
- •Patients who have been on anticoagulants for more than 6 weeks or have taken equivalent safety measures.
- •Patients with no evidence of intracardiac thrombus on transesophageal echocardiography, intracardiac echocardiography, or equivalent cardiac imaging (Cardiac CT) performed within 48 hours.
- •Patients who have made a voluntary decision to participate in this study and have given written informed consent.
- •Patients who are able to understand, follow instructions and participate for the full duration of the study.
Exclusion Criteria
- •Patients who meet any of the following criteria will be excluded.
- •Patients whose computed tomography (CT) or antecedent venography performed at the screening visit demonstrates no identifiable Marshall's vein.
- •Patients who have undergone catheter ablation for atrial fibrillation within 6 months prior to the screening visit, or who have undergone a surgical Maze procedure at any time.
- •Patients with a diagnosis of acute coronary syndrome within 3 months or who have undergone a stenting procedure or coronary artery bypass grafting in a coronary artery proximal to the anticipated procedure route at the time of the study.
- •Patients with severe heart failure and those suffering from cardiogenic shock
- •Those who are with less than 40% emissions Those with less than 40% of the ejection fraction
- •Patients with hypertrophic cardiomyopathy
- •Patients who have contraindications to contrast medias or anticoagulants
- •Patients with evidence of intra-atrial thrombus on imaging studies performed within 1 month of the procedure Patients with evidence of blood clots in the atrium on imaging tests performed within 1 month of the procedure.
- •Patients who have intracardiac malignant tumors and a life expectancy of 12 months or less
Outcomes
Primary Outcomes
Changes of electrical signals around the Marshall vein(2)
Time Frame: Immediately after the procedure
Pacing progress through unipolar electrogram between radiofrequency catheter and ground patch: Failure to conduction is evaluated as successful ablation.
Changes of electrical signals around the Marshall vein(1)
Time Frame: Immediately after the procedure
Pacing progress through unipolar electrogram between radiofrequency catheter and ground patch: Failure to conduction is evaluated as successful ablation.
Changes of electrical signals around the Marshall vein
Time Frame: Immediately after the procedure
Observation of changes in unipolar electrogram between radiofrequency catheter and ground patch before and after resection: The size of the unipolar electrogram voltage before and after the procedure is compared, and if the reduction is more than 80%, it is evaluated as a successful ablation.
Rate of adverse events as a measure of safety
Time Frame: Immediately after the procedure
Rate of composite endpoint of MACE death, myocardial infarction, cardiac tamponade, device related acrdiac surgery, stroke
Secondary Outcomes
- Adverse event(safety of procedures)(1)(1 month post-procedure)
- Adverse event(safety of procedures)(2)(1 month post-procedure)
- Efficacy of procedures(2)(1 month post-procedure)
- Efficacy of procedures(1)(1 month post-procedure)