Atrial Fibrillation
Conditions
Keywords
ablative treatment of atrial fibrillation, ballon cryoablation, radiofrequency ablation, elderly patients
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.
Interventions
PROCEDUREradiofrequency ablation
ablative treatment as allocated to radiofrequency ablation
PROCEDUREballon cryoablation
ablative treatment as allocated to ballon cryoablation
Sponsors
Vivantes Netzwerk für Gesundheit GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
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
* Dementia * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| atrial arrhythmia recurrence | 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
| Measure | Time frame | Description |
|---|---|---|
| time to wake-up after propofol withdrawal | periprocedural | Time from withdrawal of propofole till patient awake and fully oriented (time, place, person) |
| contrast medium dosis | periprocedural | Amount of contrast medium used |
| Propofoldosis | periprocedural | Propofoldosis needed for sedation |
| procedural duration | periprocedural | Duration of the whole procedure \[min\] inclusive preparation (from entrance to the EP lab till exit from the EP lab) |
| Neurological complications | 1 year | Number of Participants in each randomisation arm with transient ischemic attack, cerebral insult, cerebral haemorrhage |
| vascular complications | 1 year | Number of Participants in each randomisation arm with deep vein thrombosis, peripheral embolism. |
| duration of hospital staying [days] | 1 year | duration of hospital staying: from admission till discharge in days |
| groin complications | up to 3 months after dismission from the hospital | Number of Participants in each randomisation arm with groin complications (hematoma, av fistel, Aneuryma spurium, infection). |
Countries
Germany
Contacts
Primary ContactCharalampos Kriatselis, MD
Backup ContactMichael Distler, MD
Outcome results
None listed