Paroxysmal Atrial FibrillationNCT03912324
Computed Tomogram Myocardial Thickness Map Guided pulmOnary Vein iSolaTion vs. Empirical Pulmonary Vein Isolation in Cryoballoon Ablation for Paroxysmal Atrial Fibrillation (UTMOST AF II)
A study testing Unipolar voltage subtraction map guided PV isolation group, CT myocardial thickness map guided PV isolation group and Empirical PV isolation group in people with Paroxysmal Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
Trial summary
New parameters or methods, such as ablation index, have been developed for the quantification of high-frequency energy used in pulmonary vein isolation, but there is no known method for atrial fibrillation considering individual differences in atrial tissue. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Unipolar voltage subtraction map guided PV isolation group, CT myocardial thickness map guided PV isolation group and Empirical PV isolation group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Oct 2021to Apr 2025
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with paroxysmal atrial fibrillation who is scheduled for ablation procedure and ≥20 and ≤80 years of age
- Left atrium size < 50mm
- paroxysmal atrial fibrillation that is recurrence during antiarrhythmic drug treatment or is not able to use an antiarrhythmic drug.
- Patient who is indicated for anticoagulation therapy (for prevention of cerebral infarction)
Who cannot join
- Patients with persistent or permanent atrial fibrillation
- Atrial fibrillation associated with severe cardiac malformation or a structural heart disease that is hemodynamically affected
- Patients with severe renal impairment or CT imaging difficulty using contrast media
- Patients with a past history of radiofrequency ablation for atrial fibrillation or other cardiac surgery
- Patients with active internal bleeding
- Patients with contraindications for anticoagulation therapy(for prevention of cerebral infarction) and antiarrhythmic drugs
Show all 12Show fewer
- Patients with valvular atrial fibrillation (mitral stenosis >grade 2, mechanical valve, mitral valvuloplasty)
- Patients with a severe comorbid disease
- Expected survival < 1 year
- Drug addicts or alcoholics
- Patients who cannot read the consent form (illiterates, foreigners, etc.)
- Other patients who are judged by the principal or sub-investigator to be ineligible for participation in this clinical study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Cardiovascular Hospital, Yonsei University Health System
Seoul, 120-752
Hui-Nam Pak, M.D., Ph.D., 82-2-2228-8459, hnpak@yuhs.ac
About this study
New parameters or methods, such as ablation index, have been developed for the quantification of high-frequency energy used in pulmonary vein isolation, but there is no known method for atrial fibrillation considering individual differences in atrial tissue. The atrium is only 1/3 of the thickness of the ventricle and is thinner in women and older than men or young people.
The aim of this study was to evaluate the efficacy and safety of radiofrequency energy therapy using atrial individual differences. In order to reflect the thickness of the atrium, we will use the unipolar and bipolar maps and the myocardial thickness map using computed tomography (CT) images. To evaluate the efficacy and safety of energy titration therapy by random assignment of high frequency energy therapy group, CT image application high frequency energy therapy group, and existing empirical high frequency therapy group.
Read the detailed description
- Study design
- Prospective randomization (Unipolar voltage subtraction map guided PV(pulmonary vein) isolation group vs. CT myocardial thickness map guided PV isolation group vs. Empirical PV isolation group )
- Target number of subjects: 480 (160 per group)
- Rhythm FU : 2012 ACC/AHA/ESC guidelines (Holter monitoring at the baseline, 2 month, and thereafter every 6 months; ECG if the patient has any symptom)
- Anticoagulant therapy followed by 2014 ACC/AHA/ESC guidelines
- All complications in each group will be evaluated including the re-hospitalization rate, major cardiovascular event, and mortality rate.
- Progress and rhythm/ECG follow-up
- To be performed in accordance with the 2012 ACC/AHA/HRS guidelines for AF management
- Follow-up at 1 weeks, 3 months, and thereafter every 6-month after procedure.
- Rhythm control at 3 months, and thereafter every 6-month follow-up with Holter
- If the patient complains of symptoms, ECG will be performed at any time, and rhythm follow-up will be carried out with a Holter or event recorder.
- Follow-up All the patients will be followed-up at 1, 3, 6 months, and thereafter every 6 months. If the patient shows any symptom within the clinical study period, patient will visit the outpatient clinic. ECG will be performed at every outpatient visits, and 24-hour Holter or event recording will be performed every 6 months for 2 years, and every year after 2 years (2012 Heart Rhythm Society/EHRA/European Cardiac Arrhythmia Society Expert Consensus Statement guidelines). If atrial fibrillation or atrial tachycardia lasting more than 30 seconds is observed in 12-lead ECG or Holter, it will be evaluated as recurrence. Recurrence within 3 months after the procedure will be classified as early recurrence, and that after 3 months will be classified as clinical recurrence.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Unipolar voltage subtraction map guided PV isolation group, CT myocardial thickness map guided PV isolation group, Empirical PV isolation group
- Keywords
- Atrial fibrillation, Pulmonary vein isolation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unipolar voltage subtraction map guided PV isolation groupProcedure or surgery
- Pulmonary vein isolation will be performed using a radiofrequency catheter
- Esophageal temperature will be monitored to prevent esophageal injury
- Mapping of echocardiographic unipolar voltage subtraction after atrial septal puncture
- the electrode map data is transferred to the core lab by network to calculate the unipolar voltage subtraction color map (within 10 minutes)
- Increase radiofrequency ablation time by 2 to 5 seconds in areas with high potential in unipolar voltage subtraction color map
- Decrease radiofrequency ablation time by 2 to 5 seconds in areas with low potential in unipolar voltage subtraction color map
- Evaluation of success rate and time of pulmonary vein isolation after bilateral pulmonary vein primary columnar resection
- Evaluate time to complete isolation after additional ablation
- Evaluation of Procedure and Ablation time, and perfusion saline dose
- Rhythm follow-up after the procedure in accordance with the study design.
CT myocardial thickness map guided PV isolation groupProcedure or surgery
- Pulmonary vein isolation will be performed using a radiofrequency catheter
- Esophageal temperature will be monitored to prevent esophageal injury.
- Prepared myocardial thickness map with CT DICOM images conducted prior to procedure.
- Increase radiofrequency ablation time by 2 to 5 seconds in thick areas in CT myocardial thickness map
- Decrease radiofrequency ablation time by 2 to 5 seconds in thin areas in CT myocardial thickness map
- Evaluation of success rate and time of pulmonary vein isolation after bilateral pulmonary vein primary columnar resection
- Evaluate time to complete isolation after additional ablation
- Evaluation of Procedure time, Ablation time, and perfusion saline dose
- Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.
Empirical PV isolation groupProcedure or surgery
- Pulmonary vein isolation will be performed using a radiofrequency catheter
- Esophageal temperature will be monitored to prevent esophageal injury.
- The procedure is performed by adjusting radiofrequency energy according to the traditional method and experience of the practitioner.
- Evaluation of success rate and time of pulmonary vein isolation after bilateral pulmonary vein primary columnar resection
- Evaluate time to complete isolation after additional ablation
- Evaluation of Procedure time, Ablation time, and perfusion saline dose
- Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.
| Study group | Role | What they receive |
|---|---|---|
| Unipolar voltage subtraction map guided PV isolation group | Experimental | 1. Pulmonary vein isolation will be performed using a radiofrequency catheter
2. Esophageal temperature will be monitored to prevent esophageal injury
3. Mapping of echocardiographic unipolar voltage subtraction after atrial septal puncture
4. the electrode map data is transferred to the core lab by network to calculate the unipolar voltage subtraction color map (within 10 minutes)
5. Increase radiofrequency ablation time by 2 to 5 seconds in areas with high potential in unipolar voltage subtraction color map
6. Decrease radiofrequency ablation time by 2 to 5 seconds in areas with low potential in unipolar voltage subtraction color map
7. Evaluation of success rate and time of pulmonary vein isolation after bilateral pulmonary vein primary columnar resection
8. Evaluate time to complete isolation after additional ablation
9. Evaluation of Procedure and Ablation time, and perfusion saline dose
10. Rhythm follow-up after the procedure in accordance with the study design. Receives: Procedure: Unipolar voltage subtraction map guided PV isolation group |
| CT myocardial thickness map guided PV isolation group | Experimental | 1. Pulmonary vein isolation will be performed using a radiofrequency catheter
2. Esophageal temperature will be monitored to prevent esophageal injury.
3. Prepared myocardial thickness map with CT DICOM images conducted prior to procedure.
4. Increase radiofrequency ablation time by 2 to 5 seconds in thick areas in CT myocardial thickness map
5. Decrease radiofrequency ablation time by 2 to 5 seconds in thin areas in CT myocardial thickness map
6. Evaluation of success rate and time of pulmonary vein isolation after bilateral pulmonary vein primary columnar resection
7. Evaluate time to complete isolation after additional ablation
8. Evaluation of Procedure time, Ablation time, and perfusion saline dose
9. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design. Receives: Procedure: CT myocardial thickness map guided PV isolation group |
| Empirical PV isolation group | Active comparator | 1. Pulmonary vein isolation will be performed using a radiofrequency catheter
2. Esophageal temperature will be monitored to prevent esophageal injury.
3. The procedure is performed by adjusting radiofrequency energy according to the traditional method and experience of the practitioner.
4. Evaluation of success rate and time of pulmonary vein isolation after bilateral pulmonary vein primary columnar resection
5. Evaluate time to complete isolation after additional ablation
6. Evaluation of Procedure time, Ablation time, and perfusion saline dose
7. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design. Receives: Procedure: Empirical PV isolation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluation: Procedure-related cardiac complication rate
including open cardiac surgery, cerebral infarction, pericardial effusion or cardiac tamponade, hematoma in the inguinal puncture site and vascular complications within 30 days post procedure.
Measured: within 30 days post procedure
Efficacy evaluation: Atrial fibrillation or atrial tachycardia for at least 30 seconds after 3 months within 1 year without antiarrhythmic medication
Defined as atrial fibrillation or atrial tachycardia > 30 sec after 3 months within 1 year; based on the 2012 ACC/AHA/HRS guidelines, 24-hour Holter ECG monitoring will be performed at 2 month and every 6 months, and ECG and monitoring with a Holter or an event recorder will be performed at any time if the patient complains of symptoms
Measured: Within 1 year after 3 months of procedure
Efficacy evaluation: Major cardiovascular event rate
death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure
Measured: immediate after procedure
Efficacy evaluation: Major cardiovascular event rate
death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure
Measured: 12 months after procedure
Secondary outcomes (24)
Comparison of procedure time
Measured: immediate after procedure
Comparison of ablation time
Measured: immediate after procedure
Comparison of hospitalization period
Measured: immediate after procedure
Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate
Measured: 1 week after procedure
Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate
Measured: 3 months after procedure
Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate
Measured: 6 months after procedure
Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate
Measured: 12 months after procedure
Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate
Measured: 18 months after procedure
Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate
Measured: 24 months after procedure
Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate
Measured: 36 months after procedure
Comparison of re-hospitalization rate after the procedure
Measured: 1 week after procedure
Comparison of re-hospitalization rate after the procedure
Measured: 3 months after procedure
Comparison of re-hospitalization rate after the procedure
Measured: 6 months after procedure
Comparison of re-hospitalization rate after the procedure
Measured: 12 months after procedure
Comparison of re-hospitalization rate and number of electrical cardioversion after the procedure
Measured: 18 months after procedure
Comparison of re-hospitalization rate after the procedure
Measured: 24 months after procedure
Comparison of re-hospitalization rate after the procedure
Measured: 36 months after procedure
Comparison of number of electrical cardioversion after the procedure
Measured: 1 week months after procedure
Comparison of number of electrical cardioversion after the procedure
Measured: 3 months after procedure
Comparison of number of electrical cardioversion after the procedure
Measured: 6 after procedure
Comparison of number of electrical cardioversion after the procedure
Measured: 12 months after procedure
Comparison of number of electrical cardioversion after the procedure
Measured: 18 months after procedure
Comparison of number of electrical cardioversion after the procedure
Measured: 24 months after procedure
Comparison of number of electrical cardioversion after the procedure
Measured: 36 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 posted11 Apr 2019
- Study start6 Oct 2021
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912324
- Sponsor's protocol ID
- 4-2019-0109
- Status last verified
- Jun 2024
- First submitted
- 8 Apr 2019
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computed Tomogram Myocardial Thickness Map Guided pulmOnary Vein iSolaTion vs. Empirical Pulmonary Vein Isolation in Cryoballoon Ablation for Paroxysmal Atrial Fibrillation (UTMOST AF II)
- ClinicalTrials.gov ID
- NCT03912324
- Acronym / sponsor ID
- 4-2019-0109
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Atrial fibrillation, Pulmonary vein isolation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 11 Apr 2019 (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.
New parameters or methods, such as ablation index, have been developed for the quantification of high-frequency energy used in pulmonary vein isolation, but there is no known method for atrial fibrillation considering individual differences in atrial tissue. The atrium is only 1/3 of the thickness of the ventricle and is thinner in women and older than men or young people.
The aim of this study was to evaluate the efficacy and safety of radiofrequency energy therapy using atrial individual differences. In order to reflect the thickness of the atrium, we will use the unipolar and bipolar maps and the myocardial thickness map using computed tomography (CT) images. To evaluate the efficacy and safety of energy titration therapy by random assignment of high frequency energy therapy group, CT image application high frequency energy therapy group, and existing empirical high frequency therapy group.
Detailed description
- Study design
- Prospective randomization (Unipolar voltage subtraction map guided PV(pulmonary vein) isolation group vs. CT myocardial thickness map guided PV isolation group vs. Empirical PV isolation group )
- Target number of subjects: 480 (160 per group)
- Rhythm FU : 2012 ACC/AHA/ESC guidelines (Holter monitoring at the baseline, 2 month, and thereafter every 6 months; ECG if the patient has any symptom)
- Anticoagulant therapy followed by 2014 ACC/AHA/ESC guidelines
- All complications in each group will be evaluated including the re-hospitalization rate, major cardiovascular event, and mortality rate.
- Progress and rhythm/ECG follow-up
- To be performed in accordance with the 2012 ACC/AHA/HRS guidelines for AF management
- Follow-up at 1 weeks, 3 months, and thereafter every 6-month after procedure.
- Rhythm control at 3 months, and thereafter every 6-month follow-up with Holter
- If the patient complains of symptoms, ECG will be performed at any time, and rhythm follow-up will be carried out with a Holter or event recorder.
- Follow-up All the patients will be followed-up at 1, 3, 6 months, and thereafter every 6 months. If the patient shows any symptom within the clinical study period, patient will visit the outpatient clinic. ECG will be performed at every outpatient visits, and 24-hour Holter or event recording will be performed every 6 months for 2 years, and every year after 2 years (2012 Heart Rhythm Society/EHRA/European Cardiac Arrhythmia Society Expert Consensus Statement guidelines). If atrial fibrillation or atrial tachycardia lasting more than 30 seconds is observed in 12-lead ECG or Holter, it will be evaluated as recurrence. Recurrence within 3 months after the procedure will be classified as early recurrence, and that after 3 months will be classified as clinical recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unipolar voltage subtraction map guided PV isolation group | Experimental | Procedure: Unipolar voltage subtraction map guided PV isolation group1. Pulmonary vein isolation will be performed using a radiofrequency catheter 2. Esophageal temperature will be monitored to prevent esophageal injury 3. Mapping of echocardiographic unipolar voltage subtraction after atrial septal puncture 4. the electrode map data is transferred to the core lab by network to calculate the unipolar voltage subtraction color map (within 10 minutes) 5. Increase radiofrequency ablation time by 2 to 5 seconds in areas with high potential in unipolar voltage subtraction color map 6. Decrease radiofrequency ablation time by 2 to 5 seconds in areas with low potential in unipolar voltage subtraction color map 7. Evaluation of success rate and time of pulmonary vein isolation after bilateral pulmonary vein primary columnar resection 8. Evaluate time to complete isolation after additional ablation 9. Evaluation of Procedure and Ablation time, and perfusion saline dose 10. Rhythm follow-up after the procedure in accordance with the study design. |
| CT myocardial thickness map guided PV isolation group | Experimental | Procedure: CT myocardial thickness map guided PV isolation group1. Pulmonary vein isolation will be performed using a radiofrequency catheter 2. Esophageal temperature will be monitored to prevent esophageal injury. 3. Prepared myocardial thickness map with CT DICOM images conducted prior to procedure. 4. Increase radiofrequency ablation time by 2 to 5 seconds in thick areas in CT myocardial thickness map 5. Decrease radiofrequency ablation time by 2 to 5 seconds in thin areas in CT myocardial thickness map 6. Evaluation of success rate and time of pulmonary vein isolation after bilateral pulmonary vein primary columnar resection 7. Evaluate time to complete isolation after additional ablation 8. Evaluation of Procedure time, Ablation time, and perfusion saline dose 9. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design. |
| Empirical PV isolation group | Active comparator | Procedure: Empirical PV isolation group1. Pulmonary vein isolation will be performed using a radiofrequency catheter 2. Esophageal temperature will be monitored to prevent esophageal injury. 3. The procedure is performed by adjusting radiofrequency energy according to the traditional method and experience of the practitioner. 4. Evaluation of success rate and time of pulmonary vein isolation after bilateral pulmonary vein primary columnar resection 5. Evaluate time to complete isolation after additional ablation 6. Evaluation of Procedure time, Ablation time, and perfusion saline dose 7. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with paroxysmal atrial fibrillation who is scheduled for ablation procedure and ≥20 and ≤80 years of age
- Left atrium size < 50mm
- paroxysmal atrial fibrillation that is recurrence during antiarrhythmic drug treatment or is not able to use an antiarrhythmic drug.
- Patient who is indicated for anticoagulation therapy (for prevention of cerebral infarction)
Key exclusion criteria (12 listed)
- Patients with persistent or permanent atrial fibrillation
- Atrial fibrillation associated with severe cardiac malformation or a structural heart disease that is hemodynamically affected
- Patients with severe renal impairment or CT imaging difficulty using contrast media
- Patients with a past history of radiofrequency ablation for atrial fibrillation or other cardiac surgery
- Patients with active internal bleeding
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 |
|---|---|---|
| Unipolar voltage subtraction map guided PV isolation group1. Pulmonary vein isolation will be performed using a radiofrequency catheter 2. Esophageal temperature will be monitored to prevent esophageal injury 3. Mapping of echocardiographic unipolar voltage subtraction after atrial septal puncture 4. the electrode map data is transferred to the core lab by network to calculate the unipolar voltage subtraction color map (within 10 minutes) 5. Increase radiofrequency ablation time by 2 to 5 seconds in areas with high potential in unipolar voltage subtraction color map 6. Decrease radiofrequency ablation time by 2 to 5 seconds in areas with low potential in unipolar voltage subtraction color map 7. Evaluation of success rate and time of pulmonary vein isolation after bilateral pulmonary vein primary columnar resection 8. Evaluate time to complete isolation after additional ablation 9. Evaluation of Procedure and Ablation time, and perfusion saline dose 10. Rhythm follow-up after the procedure in accordance with the study design. | Procedure or surgery | Unipolar voltage subtraction map guided PV isolation group |
| CT myocardial thickness map guided PV isolation group1. Pulmonary vein isolation will be performed using a radiofrequency catheter 2. Esophageal temperature will be monitored to prevent esophageal injury. 3. Prepared myocardial thickness map with CT DICOM images conducted prior to procedure. 4. Increase radiofrequency ablation time by 2 to 5 seconds in thick areas in CT myocardial thickness map 5. Decrease radiofrequency ablation time by 2 to 5 seconds in thin areas in CT myocardial thickness map 6. Evaluation of success rate and time of pulmonary vein isolation after bilateral pulmonary vein primary columnar resection 7. Evaluate time to complete isolation after additional ablation 8. Evaluation of Procedure time, Ablation time, and perfusion saline dose 9. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design. | Procedure or surgery | CT myocardial thickness map guided PV isolation group |
| Empirical PV isolation group1. Pulmonary vein isolation will be performed using a radiofrequency catheter 2. Esophageal temperature will be monitored to prevent esophageal injury. 3. The procedure is performed by adjusting radiofrequency energy according to the traditional method and experience of the practitioner. 4. Evaluation of success rate and time of pulmonary vein isolation after bilateral pulmonary vein primary columnar resection 5. Evaluate time to complete isolation after additional ablation 6. Evaluation of Procedure time, Ablation time, and perfusion saline dose 7. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design. | Procedure or surgery | Empirical PV isolation group |
Primary outcome
Safety evaluation: Procedure-related cardiac complication rate
Time frame: within 30 days post procedure
including open cardiac surgery, cerebral infarction, pericardial effusion or cardiac tamponade, hematoma in the inguinal puncture site and vascular complications within 30 days post procedure.
Efficacy evaluation: Atrial fibrillation or atrial tachycardia for at least 30 seconds after 3 months within 1 year without antiarrhythmic medication
Time frame: Within 1 year after 3 months of procedure
Defined as atrial fibrillation or atrial tachycardia > 30 sec after 3 months within 1 year; based on the 2012 ACC/AHA/HRS guidelines, 24-hour Holter ECG monitoring will be performed at 2 month and every 6 months, and ECG and monitoring with a Holter or an event recorder will be performed at any time if the patient complains of symptoms
Efficacy evaluation: Major cardiovascular event rate
Time frame: immediate after procedure
death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure
Efficacy evaluation: Major cardiovascular event rate
Time frame: 12 months after procedure
death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure
24 secondary outcomes
Comparison of procedure time
Time frame: immediate after procedure
Comparison of ablation time
Time frame: immediate after procedure
Comparison of hospitalization period
Time frame: immediate after procedure
Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate
Time frame: 1 week after procedure
Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate
Time frame: 3 months after procedure
Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate
Time frame: 6 months after procedure
Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate
Time frame: 12 months after procedure
Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate
Time frame: 18 months after procedure
Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate
Time frame: 24 months after procedure
Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate
Time frame: 36 months after procedure
Comparison of re-hospitalization rate after the procedure
Time frame: 1 week after procedure
Comparison of re-hospitalization rate after the procedure
Time frame: 3 months after procedure
Comparison of re-hospitalization rate after the procedure
Time frame: 6 months after procedure
Comparison of re-hospitalization rate after the procedure
Time frame: 12 months after procedure
Comparison of re-hospitalization rate and number of electrical cardioversion after the procedure
Time frame: 18 months after procedure
Comparison of re-hospitalization rate after the procedure
Time frame: 24 months after procedure
Comparison of re-hospitalization rate after the procedure
Time frame: 36 months after procedure
Comparison of number of electrical cardioversion after the procedure
Time frame: 1 week months after procedure
Comparison of number of electrical cardioversion after the procedure
Time frame: 3 months after procedure
Comparison of number of electrical cardioversion after the procedure
Time frame: 6 after procedure
Comparison of number of electrical cardioversion after the procedure
Time frame: 12 months after procedure
Comparison of number of electrical cardioversion after the procedure
Time frame: 18 months after procedure
Comparison of number of electrical cardioversion after the procedure
Time frame: 24 months after procedure
Comparison of number of electrical cardioversion after the procedure
Time frame: 36 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 13 Jun 2024.
- 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. This study is not recruiting at the moment.
Severance Cardiovascular Hospital, Yonsei University Health System
Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unipolar voltage subtraction map guided PV isolation group, CT myocardial thickness map guided PV isolation group and Empirical PV isolation group in people with Paroxysmal Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
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 4 inclusion and 12 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 13 Jun 2024. 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 South Korea. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety evaluation: Procedure-related cardiac complication rate (time frame: within 30 days post procedure). The study lists 4 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 13 Jun 2024.