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Unipolar Voltage Map and Computed Tomogram Myocardial Thickness Map Guided pulmOnary Vein iSolaTion vs. Empirical Pulmonary Vein Isolation in Catheter Ablation for Paroxysmal Atrial Fibrillation (UTMOST AF)

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ClinicalTrials.gov Identifier: NCT03912324
Recruitment Status : Not yet recruiting
First Posted : April 11, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Procedure: Unipolar voltage subtraction map guided PV isolation group Procedure: CT myocardial thickness map guided PV isolation group Procedure: Empirical PV isolation group Not Applicable

Detailed Description:

A. Study design

  1. 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 )
  2. Target number of subjects: 480 (160 per group)
  3. 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)
  4. Anticoagulant therapy followed by 2014 ACC/AHA/ESC guidelines
  5. All complications in each group will be evaluated including the re-hospitalization rate, major cardiovascular event, and mortality rate.

B. Progress and rhythm/ECG follow-up

  1. To be performed in accordance with the 2012 ACC/AHA/HRS guidelines for AF management
  2. Follow-up at 1 weeks, 3 months, and thereafter every 6-month after procedure.
  3. Rhythm control at 3 months, and thereafter every 6-month follow-up with Holter
  4. 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.

C. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Unipolar Voltage Map and Computed Tomogram Myocardial Thickness Map Guided pulmOnary Vein iSolaTion vs. Empirical Pulmonary Vein Isolation in Catheter Ablation for Paroxysmal Atrial Fibrillation (UTMOST AF)
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Unipolar voltage subtraction map guided PV isolation group
  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.
Procedure: Unipolar voltage subtraction map guided PV isolation group
  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.

Experimental: CT myocardial thickness map guided PV isolation group
  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.
Procedure: CT myocardial thickness map guided PV isolation group
  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.

Active Comparator: Empirical PV isolation group
  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.
Procedure: Empirical PV isolation group
  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.




Primary Outcome Measures :
  1. 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.

  2. Efficacy evaluation: clinical recurrence rate [ 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

  3. Efficacy evaluation: Major cardiovascular event rate [ Time Frame: immediate after procedure ]
    death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure

  4. 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


Secondary Outcome Measures :
  1. Comparison of procedure time [ Time Frame: immediate after procedure ]
  2. Comparison of ablation time [ Time Frame: immediate after procedure ]
  3. Comparison of hospitalization period [ Time Frame: immediate after procedure ]
  4. Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate [ Time Frame: 1 week after procedure ]
  5. Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate [ Time Frame: 3 months after procedure ]
  6. Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate [ Time Frame: 6 months after procedure ]
  7. Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate [ Time Frame: 12 months after procedure ]
  8. Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate [ Time Frame: 18 months after procedure ]
  9. Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate [ Time Frame: 24 months after procedure ]
  10. Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate [ Time Frame: 36 months after procedure ]
  11. Comparison of re-hospitalization rate after the procedure [ Time Frame: 1 week after procedure ]
  12. Comparison of re-hospitalization rate after the procedure [ Time Frame: 3 months after procedure ]
  13. Comparison of re-hospitalization rate after the procedure [ Time Frame: 6 months after procedure ]
  14. Comparison of re-hospitalization rate after the procedure [ Time Frame: 12 months after procedure ]
  15. Comparison of re-hospitalization rate and number of electrical cardioversion after the procedure [ Time Frame: 18 months after procedure ]
  16. Comparison of re-hospitalization rate after the procedure [ Time Frame: 24 months after procedure ]
  17. Comparison of re-hospitalization rate after the procedure [ Time Frame: 36 months after procedure ]
  18. Comparison of number of electrical cardioversion after the procedure [ Time Frame: 1 week months after procedure ]
  19. Comparison of number of electrical cardioversion after the procedure [ Time Frame: 3 months after procedure ]
  20. Comparison of number of electrical cardioversion after the procedure [ Time Frame: 6 after procedure ]
  21. Comparison of number of electrical cardioversion after the procedure [ Time Frame: 12 months after procedure ]
  22. Comparison of number of electrical cardioversion after the procedure [ Time Frame: 18 months after procedure ]
  23. Comparison of number of electrical cardioversion after the procedure [ Time Frame: 24 months after procedure ]
  24. Comparison of number of electrical cardioversion after the procedure [ Time Frame: 36 months after procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Patient with paroxysmal atrial fibrillation who is scheduled for ablation procedure and ≥20 and ≤80 years of age
  • 2. Left atrium size < 45mm
  • 3. paroxysmal atrial fibrillation that is recurrence during antiarrhythmic drug treatment or is not able to use an antiarrhythmic drug.
  • 4. Patient who is indicated for anticoagulation therapy (for prevention of cerebral infarction)

Exclusion Criteria:

  • 1. Patients with persistent or permanent atrial fibrillation
  • 2. Atrial fibrillation associated with severe cardiac malformation or a structural heart disease that is hemodynamically affected
  • 3. Patients with severe renal impairment or CT imaging difficulty using contrast media
  • 4. Patients with a past history of radiofrequency ablation for atrial fibrillation or other cardiac surgery
  • 5. Patients with active internal bleeding
  • 6. Patients with contraindications for anticoagulation therapy(for prevention of cerebral infarction) and antiarrhythmic drugs
  • 7. Patients with valvular atrial fibrillation (mitral stenosis >grade 2, mechanical valve, mitral valvuloplasty)
  • 8. Patients with a severe comorbid disease
  • 9. Expected survival < 1 year
  • 10. Drug addicts or alcoholics
  • 11. Patients who cannot read the consent form (illiterates, foreigners, etc.)
  • 12. Other patients who are judged by the principal or sub-investigator to be ineligible for participation in this clinical study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912324


Locations
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Korea, Republic of
Severance Cardiovascular Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03912324     History of Changes
Other Study ID Numbers: 4-2019-0109
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yonsei University:
Atrial fibrillation
Pulmonary vein isolation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes