Atrial Fibrillation Clinical Trial
Official title:
Prospective Registry of Atrial Fibrillation Cryoballoon Ablation in the Russian Federation
NCT number | NCT03040037 |
Other study ID # | PRAF-CA |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2017 |
Est. completion date | March 21, 2022 |
This is a prospective registry of atrial fibrillation cryoablation in the Russian Federation. This study is observational, prospective, multicenter, open-label
Status | Completed |
Enrollment | 1100 |
Est. completion date | March 21, 2022 |
Est. primary completion date | July 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - The indications for catheter ablation of atrial fibrillation - Signed informed consent to participate in the Register - Patients undergoing cryoballoon ablation Exclusion Criteria: - Left atrial thrombosis |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Federal State Budgetary Institution "V. A. Almazov Federal North-West Medical Research Centre" of the Ministry of Health of the Russian Federation | Saint-Petersburg |
Lead Sponsor | Collaborator |
---|---|
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health | RUSSIAN SOCIETY OF CARDIOLOGY |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Freedom from arrhythmia: Number of participants with no evidence of atrial achyarrhythmia longer than 30 s, as detected by regular ECG monitoring | ECG monitoring will be performed in accordance with sites' routine practices (Holter monitoring every 3 months, implantable loop recorder, cardiac rhythm management device interrogation, other regular ECG screening) | 1 Year | |
Secondary | Number of participants with adverse events that are related to treatment (i.e. cardiac tamponade, periprocedural stroke, pulmonary vein stenosis, esophageal damage, etc) | 1 Year | ||
Secondary | Number of participants with adverse events that are related to underlying disease (cardiovascular events not related to atrial fibrillation cryoablation) | 1 Year | ||
Secondary | Atrial fibrillation procedure characteristics: Mean total ablation procedure time in minutes, mean fluoroscopy time in minutes (during the ablation procedure) | Data will be collected using a web-based system of electronic case report forms | Above parameters will be assessed only during the procedure of cryoablation | |
Secondary | Number of participants with antiarrhythmic drug treatment at 12 months | 1 Year |
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