A Prospective Randomized Trial for the Comparison of Procedural Characteristics and Long-term Effects of Radiofrequency Ablation and Balloon Cryoablation in Elderly Patients With Atrial Fibrillation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Vivantes Netzwerk für Gesundheit GmbH
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- atrial arrhythmia recurrence
- Last Updated
- 6 years ago
Overview
Brief Summary
This study compares the procedural characteristics and effectivity of radiofrequency ablation and cryoablation in patients with atrial fibrillation that are 75 years or older.
Detailed Description
Radiofrequency and cryoballon ablation have been shown to be comparable to each other in terms of safety and effectivity in patients with atrial fibrillation. However, elderly patients have been underrepresented in the previous studies. The number of older patients with atrial fibrillation is high and the number of who undergo an ablation procedure for atrial fibrillation increases steadily. This prospective randomized trial compares the effectivity (recurrency of atrial arrhythmias) and periprocedural characteristics of the two established ablation methods in patients who are 75 years or older.
Investigators
Charalampos Kriatselis
Principal Investigator
Vivantes Netzwerk für Gesundheit GmbH
Eligibility Criteria
Inclusion Criteria
- •Patients with recurrent symptomatic paroxysmal or persistent atrial fibrillation
- •At the day of their inclusion in the study the patients have to have completed the 75th year of life
Exclusion Criteria
- •Presence of left atrial thrombus
- •Left atrial volume\> 50 ml/m²
- •Renal failure (GFR≤ 30 ml/min)
- •Comorbidity with an expected survival of 12 months or less.
Outcomes
Primary Outcomes
atrial arrhythmia recurrence
Time Frame: 1 year
Number of Participants with recurrence of any atrial arrhythmia with a duration of 30 sec or longer 12 months after the ablative treatment
Secondary Outcomes
- procedural duration(periprocedural)
- contrast medium dosis(periprocedural)
- vascular complications(1 year)
- Propofoldosis(periprocedural)
- groin complications(up to 3 months after dismission from the hospital)
- time to wake-up after propofol withdrawal(periprocedural)
- Neurological complications(1 year)
- duration of hospital staying [days](1 year)