NCT03920891Not yet recruiting
Cryoballoon Pulmonary Vein Isolation vs. Radiofrequency Pulmonary Vein Isolation With Additional Right Atrial Linear Ablation for Valvular Atrial Fibrillation: Prospective Randomized Trial (CRAVA Trial)
Source: ClinicalTrials.gov · Last updated 19 Apr 2019 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 154 (estimated)
- First submitted
- 14 Apr 2019
- Start date
- May 2019
- Primary completion date
- Mar 2029
- Lead sponsor
- Yonsei University
- Diseases
- Atrial fibrillation
- NCT number
- NCT03920891
What you commit to
- Study type: Interventional
- Planned participants: 154
- From May 2019 to the primary completion date, Mar 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 6\. Patients with contraindications for anticoagulation therapy(for prevention of cerebral infarction) and antiarrhythmic drugs
- 10\. Drug addicts or alcoholics
Other illness
- 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
- 8\. Patients with a severe comorbid disease
Other
- 1\. Patients with permanent atrial fibrillation
- 7\. Patients with non-valvular atrial fibrillation
- 9\. Expected survival \< 1 year
- 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
Who the study is looking for
- 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)
Age in the registry: 20 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Severance Cardiovascular Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.