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The Study for Evaluate of Safety and Efficacy of Vein of Marshall RF Ablation

Primary Purpose

Persistent Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
TIRA-VoM
Sponsored by
Tau Pnu Medical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Persistent Atrial Fibrillation focused on measuring Marshall vein ablation, radiofrequency catheter ablation, vein of Marshall ablation, VoM, TauPnu

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 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 whose computed tomography (CT) or antecedent venography demonstrate that Marshall's veins are less than 1 mm in diameter and less than 15 mm in length. Patient whose Marshall vein was confirmed to be less than 1 mm in diameter and less than 15 mm in length through computed tomography (CT) or total venogram. Patients who previously had atrial fibrillation ablation or Maze surgery 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 Subjects with severe renal dysfunction (creatinine cleararnce < 30ml/min) Pregnant women, nursing mothers, and women who are planning to become pregnant or who may become pregnant during the study but are not using medically acceptable contraception Participation in other clinical trials within 30 days prior to screening Patients who participated in other clinical trials within 30 days prior to screening. In addition to the above, those who have clinical findings that the principal investigator or person in charge deems inappropriate for this study based on medical judgment. In addition to the above, those who have clinically signifcant findings that are considered inappropriate for this study as determined medically by the principal investigator or person in charge.

Sites / Locations

  • Pusan National University Yangsan HospitalRecruiting
  • Asan Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TIRA-VoM

Arm Description

treated with transcatheter RF ablation system (TIRA catheter with its supplemental devices)

Outcomes

Primary Outcome Measures

Changes of electrical signals around the Marshall vein(1)
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(2)
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
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
Rate of composite endpoint of MACE death, myocardial infarction, cardiac tamponade, device related acrdiac surgery, stroke

Secondary Outcome Measures

Efficacy of procedures(1)
The Standard 12 Lead ECG : Whether normal sinus rhythm is maintained after surgery
Efficacy of procedures(2)
24-hour Holter monitoring : Recurrence rate of atrial tachycardia/atrial fibrillation more than 30 seconds after the procedure
Adverse event(safety of procedures)(1)
All adverse event rate, including Serious Adverse Events (SAEs) and Serious Device Adverse Events (SADEs). : Myocardial infarction due to coronary artery damage, intracardiac conduction disorder, pericardial tamponade, cardiac surgery related to medical devices, stroke, death, etc.
Adverse event(safety of procedures)(2)
CT : Whether there is contracture or narrowing of the pulmonary veins at the treatment site.

Full Information

First Posted
April 21, 2023
Last Updated
May 2, 2023
Sponsor
Tau Pnu Medical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05854238
Brief Title
The Study for Evaluate of Safety and Efficacy of Vein of Marshall RF Ablation
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2023 (Anticipated)
Primary Completion Date
November 7, 2024 (Anticipated)
Study Completion Date
April 7, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tau Pnu Medical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation
Keywords
Marshall vein ablation, radiofrequency catheter ablation, vein of Marshall ablation, VoM, TauPnu

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
multicenter, open, single design, researcher-led, exploratory study
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TIRA-VoM
Arm Type
Experimental
Arm Description
treated with transcatheter RF ablation system (TIRA catheter with its supplemental devices)
Intervention Type
Device
Intervention Name(s)
TIRA-VoM
Other Intervention Name(s)
VA510, VA515, VA410, VA415, VoM
Intervention Description
treat persistent atrial fibrillation The ablation temperature range is 50-60℃ About 2 minutes per ablation
Primary Outcome Measure Information:
Title
Changes of electrical signals around the Marshall vein(1)
Description
Pacing progress through unipolar electrogram between radiofrequency catheter and ground patch: Failure to conduction is evaluated as successful ablation.
Time Frame
Immediately after the procedure
Title
Changes of electrical signals around the Marshall vein(2)
Description
Pacing progress through unipolar electrogram between radiofrequency catheter and ground patch: Failure to conduction is evaluated as successful ablation.
Time Frame
Immediately after the procedure
Title
Changes of electrical signals around the Marshall vein
Description
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.
Time Frame
Immediately after the procedure
Title
Rate of adverse events as a measure of safety
Description
Rate of composite endpoint of MACE death, myocardial infarction, cardiac tamponade, device related acrdiac surgery, stroke
Time Frame
Immediately after the procedure
Secondary Outcome Measure Information:
Title
Efficacy of procedures(1)
Description
The Standard 12 Lead ECG : Whether normal sinus rhythm is maintained after surgery
Time Frame
1 month post-procedure
Title
Efficacy of procedures(2)
Description
24-hour Holter monitoring : Recurrence rate of atrial tachycardia/atrial fibrillation more than 30 seconds after the procedure
Time Frame
1 month post-procedure
Title
Adverse event(safety of procedures)(1)
Description
All adverse event rate, including Serious Adverse Events (SAEs) and Serious Device Adverse Events (SADEs). : Myocardial infarction due to coronary artery damage, intracardiac conduction disorder, pericardial tamponade, cardiac surgery related to medical devices, stroke, death, etc.
Time Frame
1 month post-procedure
Title
Adverse event(safety of procedures)(2)
Description
CT : Whether there is contracture or narrowing of the pulmonary veins at the treatment site.
Time Frame
1 month post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 whose computed tomography (CT) or antecedent venography demonstrate that Marshall's veins are less than 1 mm in diameter and less than 15 mm in length. Patient whose Marshall vein was confirmed to be less than 1 mm in diameter and less than 15 mm in length through computed tomography (CT) or total venogram. Patients who previously had atrial fibrillation ablation or Maze surgery 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 Subjects with severe renal dysfunction (creatinine cleararnce < 30ml/min) Pregnant women, nursing mothers, and women who are planning to become pregnant or who may become pregnant during the study but are not using medically acceptable contraception Participation in other clinical trials within 30 days prior to screening Patients who participated in other clinical trials within 30 days prior to screening. In addition to the above, those who have clinical findings that the principal investigator or person in charge deems inappropriate for this study based on medical judgment. In addition to the above, those who have clinically signifcant findings that are considered inappropriate for this study as determined medically by the principal investigator or person in charge.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min-Soo Cho, MD, PhD
Phone
+82230103170
Email
d070294@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
June-Hong Kim, MD, PhD
Phone
+82553678783
Email
junehongk@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min-Soo Cho, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeongsangnamdo
ZIP/Postal Code
626-770
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ki Won Hwang, MD, PhD
Phone
+82553601459
Email
korea.hwang@gmail.com
First Name & Middle Initial & Last Name & Degree
Ki Won Hwang, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jeongsu Kim, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jin Hee Choi, MD, PhD
First Name & Middle Initial & Last Name & Degree
Minku Chon, MD, PhD
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-gu
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Soo Cho, MD, PhD
Phone
+8230101327
Email
d070294@gmail.com
First Name & Middle Initial & Last Name & Degree
Min Soo Cho, MD, PhD
First Name & Middle Initial & Last Name & Degree
Gi-Byeong Nam, MD, PhD
First Name & Middle Initial & Last Name & Degree
Myung-Jin Cha, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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The Study for Evaluate of Safety and Efficacy of Vein of Marshall RF Ablation

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