- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03920891
Cryoballoon Pulmonary Vein Isolation vs. Radiofrequency Pulmonary Vein Isolation With Additional Right Atrial Linear Ablation for Valvular Atrial Fibrillation: Prospective Randomized Trial (CRAVA Trial)
Study Overview
Status
Conditions
Detailed Description
A. Study design
- Prospective randomization (cryoballoon PV isolation group vs. Radiofrequency Pulmonary Vein isolation and Additional Right Atrial linear ablation) (Using the Python program, a random number module is imported with the import random syntax, and the random number table for the two groups is created.)
- Target number of subjects: 154 (77 per group)
- Rhythm FU : 2012 ACC/AHA/ESC guidelines (Holter monitoring at the baseline, 3,6 month, and thereafter every 6 months to 24 month, then every 1 year; 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.
B. 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, 3,6 months, and thereafter every 6-month after procedure.
- Rhythm control at 3, 6 months, and thereafter every 6 months for 2 years, and every year after 2 years 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.
C. Follow-up All the patients will be followed-up at 1 weeks, 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 3, 6 months, and thereafter 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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Seoul, Korea, Republic of, 120-752
- Severance Cardiovascular Hospital, Yonsei University Health System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 1. Patient with hemodynamic corrected valvular atrial fibrillation who is scheduled for ablation procedure and ≥20 and ≤80 years of age
- 2. Left atrium size < 50mm
- 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 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 non-valvular atrial fibrillation
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cryoballoon Pulmonary Vein isolation
|
|
Active Comparator: Radiofrequency Pulmonary Vein isolation
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|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
within 30 days post procedure
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Efficacy evaluation: clinical recurrence rate
Time Frame: Within 1 year after 3 months of procedure
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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 3 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
|
Within 1 year after 3 months of procedure
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison of procedure time
Time Frame: immediate after procedure
|
immediate after procedure
|
Comparison of ablation time
Time Frame: immediate after procedure
|
immediate after procedure
|
Comparison of hospitalization period
Time Frame: immediate after procedure
|
immediate after procedure
|
Comparison of re-hospitalization rate after the procedure
Time Frame: immediate after procedure
|
immediate after procedure
|
Comparison of re-hospitalization rate after the procedure
Time Frame: 12 months after procedure
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12 months after procedure
|
Comparison of number of electrical cardioversion after the procedure
Time Frame: immediate after procedure
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immediate after procedure
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Comparison of number of electrical cardioversion after the procedure
Time Frame: 12 months after procedure
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12 months after procedure
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Major cardiovascular event rate - death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure
Time Frame: immediate after procedure and 12 months after procedure
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immediate after procedure and 12 months after procedure
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2019-0141
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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