Valvular Atrial FibrillationNCT03920891
Cryoballoon Pulmonary Vein Isolation vs. Radiofrequency Pulmonary Vein Isolation With Additional Right Atrial Linear Ablation for Valvular Atrial Fibrillation: Prospective Randomized Trial (CRAVA Trial)
A study testing Cryoballoon Pulmonary Vein isolation and Radiofrequency Pulmonary Vein isolation and Additional Right Atrial linear ablation in people with Valvular Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
Trial summary
Cryoballoon ablation is proven to be effective in pulmonary vein isolation in patients with paroxysmal and persistent atrial fibrillation. We previously reported that the rhythm outcome of radiofrequency (RF) catheter ablations are equivalent in patients with non-valvular atrial fibrillation and in those with… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Valvular Atrial Fibrillation
- What is being tested?
- Cryoballoon Pulmonary Vein isolation and Radiofrequency Pulmonary Vein isolation and Additional Right Atrial linear ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2019to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Severance Cardiovascular Hospital, Yonsei University Health System
Seoul, 120-752
About this study
Cryoballoon ablation is proven to be effective in pulmonary vein isolation in patients with paroxysmal and persistent atrial fibrillation. We previously reported that the rhythm outcome of radiofrequency (RF) catheter ablations are equivalent in patients with non-valvular atrial fibrillation and in those with surgically and hemodynamically corrected valvular atrial fibrillation. In contrast, the Cryoballoon ablation can reduce the procedure times, it cannot conduct empirical linear ablation or extra-pulmonary vein foci ablation. The aim of this study is to compare Cryoballoon pulmonary vein isolation and RF ablation including linear ablation or extra-pulmonary vein foci ablations in patients with hemodynamically corrected valvular atrial fibrillation.
Read the detailed description
- 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.
- 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.
- 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.
- Conditions
- Valvular Atrial Fibrillation
- Being tested
- Cryoballoon Pulmonary Vein isolation, Radiofrequency Pulmonary Vein isolation and Additional Right Atrial linear ablation
- Keywords
- Valvular Atrial fibrillation, Radiofrequency Pulmonary vein isolation, Cryoballoon Pulmonary Vein isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoballoon Pulmonary Vein isolationProcedure or surgery
- Pulmonary vein isolation will be performed using a cryoballoon catheter.
- Esophageal temperature will be monitored to prevent esophageal injury.
- A 28mm second or third cryoballoon catheter will be used.
- Esophageal temperature will be monitored to prevent esophageal injury.
- Cryoablation will be performed for 180 secs at -45°C or below on condition that the pulmonary vein is occluded with a cryoballoon.
- CMAP (compound motor action potential) monitoring will be done to avoid phrenic nerve damage during the freezing of the right superior pulmonary vein.
- The procedure and cryoablation times will be evaluated.
- Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.
Radiofrequency Pulmonary Vein isolation and Additional Right Atrial linear ablationProcedure or surgery
- Pulmonary vein isolation will be performed using a radiofrequency catheter.
- Additional left atrium posterior wall isolation, left atrium anterior wall linear ablation, cavo-tricuspid isthmus ablation, superior vena cava-right atrial septal ablation.
- If any other trigger came from beyond pulmonary vein is detected after the administration of isoproterenol, additional local radiofrequency ablation will be followed.
- Evaluated the procedure and radiofrequency ablation time.
- Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.
| Study group | Role | What they receive |
|---|---|---|
| Cryoballoon Pulmonary Vein isolation | Experimental | 1. Pulmonary vein isolation will be performed using a cryoballoon catheter.
2. Esophageal temperature will be monitored to prevent esophageal injury.
3. A 28mm second or third cryoballoon catheter will be used.
4. Esophageal temperature will be monitored to prevent esophageal injury.
5. Cryoablation will be performed for 180 secs at -45°C or below on condition that the pulmonary vein is occluded with a cryoballoon.
6. CMAP (compound motor action potential) monitoring will be done to avoid phrenic nerve damage during the freezing of the right superior pulmonary vein.
7. The procedure and cryoablation times will be evaluated.
8. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design. Receives: Procedure: Cryoballoon Pulmonary Vein isolation |
| Radiofrequency Pulmonary Vein isolation | Active comparator | 1. Pulmonary vein isolation will be performed using a radiofrequency catheter.
2. Additional left atrium posterior wall isolation, left atrium anterior wall linear ablation, cavo-tricuspid isthmus ablation, superior vena cava-right atrial septal ablation.
3. If any other trigger came from beyond pulmonary vein is detected after the administration of isoproterenol, additional local radiofrequency ablation will be followed.
4. Evaluated the procedure and radiofrequency ablation time.
5. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design. Receives: Procedure: Radiofrequency Pulmonary Vein isolation and Additional Right Atrial linear ablation |
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: clinical recurrence rate
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
Measured: Within 1 year after 3 months of procedure
Secondary outcomes (8)
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 re-hospitalization rate after the procedure
Measured: immediate after procedure
Comparison of re-hospitalization rate after the procedure
Measured: 12 months after procedure
Comparison of number of electrical cardioversion after the procedure
Measured: immediate after procedure
Comparison of number of electrical cardioversion after the procedure
Measured: 12 months after procedure
Major cardiovascular event rate - death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure
Measured: immediate after procedure and 12 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 posted19 Apr 2019
- Study startMay 2019 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular 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
- 154 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
- NCT03920891
- Sponsor's protocol ID
- 4-2019-0141
- Status last verified
- Apr 2019
- First submitted
- 14 Apr 2019
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoballoon Pulmonary Vein Isolation vs. Radiofrequency Pulmonary Vein Isolation With Additional Right Atrial Linear Ablation for Valvular Atrial Fibrillation: Prospective Randomized Trial (CRAVA Trial)
- ClinicalTrials.gov ID
- NCT03920891
- Acronym / sponsor ID
- 4-2019-0141
- Conditions
- Valvular Atrial Fibrillation
- Keywords
- Valvular Atrial fibrillation, Radiofrequency Pulmonary vein isolation, Cryoballoon Pulmonary Vein isolation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2019 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 19 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.
Cryoballoon ablation is proven to be effective in pulmonary vein isolation in patients with paroxysmal and persistent atrial fibrillation. We previously reported that the rhythm outcome of radiofrequency (RF) catheter ablations are equivalent in patients with non-valvular atrial fibrillation and in those with surgically and hemodynamically corrected valvular atrial fibrillation. In contrast, the Cryoballoon ablation can reduce the procedure times, it cannot conduct empirical linear ablation or extra-pulmonary vein foci ablation. The aim of this study is to compare Cryoballoon pulmonary vein isolation and RF ablation including linear ablation or extra-pulmonary vein foci ablations in patients with hemodynamically corrected valvular atrial fibrillation.
Detailed description
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryoballoon Pulmonary Vein isolation | Experimental | Procedure: Cryoballoon Pulmonary Vein isolation1. Pulmonary vein isolation will be performed using a cryoballoon catheter. 2. Esophageal temperature will be monitored to prevent esophageal injury. 3. A 28mm second or third cryoballoon catheter will be used. 4. Esophageal temperature will be monitored to prevent esophageal injury. 5. Cryoablation will be performed for 180 secs at -45°C or below on condition that the pulmonary vein is occluded with a cryoballoon. 6. CMAP (compound motor action potential) monitoring will be done to avoid phrenic nerve damage during the freezing of the right superior pulmonary vein. 7. The procedure and cryoablation times will be evaluated. 8. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design. |
| Radiofrequency Pulmonary Vein isolation | Active comparator | Procedure: Radiofrequency Pulmonary Vein isolation and Additional Right Atrial linear ablation1. Pulmonary vein isolation will be performed using a radiofrequency catheter. 2. Additional left atrium posterior wall isolation, left atrium anterior wall linear ablation, cavo-tricuspid isthmus ablation, superior vena cava-right atrial septal ablation. 3. If any other trigger came from beyond pulmonary vein is detected after the administration of isoproterenol, additional local radiofrequency ablation will be followed. 4. Evaluated the procedure and radiofrequency ablation time. 5. 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)
- 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)
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| Cryoballoon Pulmonary Vein isolation1. Pulmonary vein isolation will be performed using a cryoballoon catheter. 2. Esophageal temperature will be monitored to prevent esophageal injury. 3. A 28mm second or third cryoballoon catheter will be used. 4. Esophageal temperature will be monitored to prevent esophageal injury. 5. Cryoablation will be performed for 180 secs at -45°C or below on condition that the pulmonary vein is occluded with a cryoballoon. 6. CMAP (compound motor action potential) monitoring will be done to avoid phrenic nerve damage during the freezing of the right superior pulmonary vein. 7. The procedure and cryoablation times will be evaluated. 8. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design. | Procedure or surgery | Cryoballoon Pulmonary Vein isolation |
| Radiofrequency Pulmonary Vein isolation and Additional Right Atrial linear ablation1. Pulmonary vein isolation will be performed using a radiofrequency catheter. 2. Additional left atrium posterior wall isolation, left atrium anterior wall linear ablation, cavo-tricuspid isthmus ablation, superior vena cava-right atrial septal ablation. 3. If any other trigger came from beyond pulmonary vein is detected after the administration of isoproterenol, additional local radiofrequency ablation will be followed. 4. Evaluated the procedure and radiofrequency ablation time. 5. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design. | Procedure or surgery | Radiofrequency Pulmonary Vein isolation |
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: 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 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
8 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 re-hospitalization rate after the procedure
Time frame: immediate after procedure
Comparison of re-hospitalization rate after the procedure
Time frame: 12 months after procedure
Comparison of number of electrical cardioversion after the procedure
Time frame: immediate after procedure
Comparison of number of electrical cardioversion after the procedure
Time frame: 12 months after procedure
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoballoon Pulmonary Vein isolation and Radiofrequency Pulmonary Vein isolation and Additional Right Atrial linear ablation in people with Valvular 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: opening soon, as of the sponsor's last update on 19 Apr 2019. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 2 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 19 Apr 2019.