Status:
UNKNOWN
Balloon Cryoablation Without Contrast
Lead Sponsor:
Medicover Hospital
Collaborating Sponsors:
National Institute of Cardiology, Warsaw, Poland
Conditions:
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Pulmonary vein isolation using cryoballoon ablation is well established method for the treatment of atrial fibrillation. As a rule, cryoenergy delivery is preceded by documenting the full vein occlusi...
Detailed Description
Pulmonary vein isolation using cryoballoon ablation is well established method for the treatment of atrial fibrillation. As a rule, cryoenergy delivery is preceded by documenting the full vein occlusi...
Eligibility Criteria
Inclusion
- Patients with paroxysmal AF - episodes lasting up to 7 days or cardioverted before this time
- At least 4 AF attacks in the last 12 months
- Informed consent for participation in the study
- Age \> 18 and \< 70 years
- Left atrium diameter (PLAX) \< 4,5 cm and left atrial area \< = 30 cm2
- Left ventricle ejection fraction \> 45%
- Four separate veins visualised in computed tomography prior to the ablation
Exclusion
- Withdrawal of consent for the procedure
- Documented typical atrial flutter prior to the ablation
- Thrombus in left atrium
- GFR \< 60 ml/min
- Pregnancy
- Common trunk of left or right pulmonary veins documented on computed tomography (preferred) or by means of other imaging methods
- Other conditions that preclude AF ablation including: infection, uncontrolled hyperthyroidism, significant anaemia and thrombocytopenia, acute cardiac / internist / surgical conditions
Key Trial Info
Start Date :
August 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04344743
Start Date
August 13 2020
End Date
June 1 2022
Last Update
September 9 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Medicover Hospital
Warsaw, Poland
2
National Institute of Cardiology
Warsaw, Poland