I48.10
Conditions
Interventions
Group 1: PVI with irrigated tip radiofrequency current
Group 2: PVI with irrigated tip RFC with advanced irrigation
Group 3: PVI with cryoballoon
Group 4: PVI with laser balloon
Sponsors
Cardoangiologisches Centrum Bethanien
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Drug-refractory paroxysmal AF with PVI indication. Age 18-75 years. LA size 45%
Exclusion criteria
Exclusion criteria: Contraindications to PVI Pacemaker or ICD Contraindications to MRI History of stroke or TIA CHADS Score > 2 Presence of intracardial thrombus as assessed by pre-procedural TEE Pregnancy Chronic renal failure Enrolled in another clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of cerebral thrombembolism within 48h after PVI detected by MRI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinically symptomatic thrombembolism (e.g. paresis, diplopia etc) within 4 weeks after the PVI and its anatomical distribution detected by MRI. | — |
Countries
Germany
Contacts
Public ContactBoris Schmidt
Cardoangiologisches Centrum Bethanien
Outcome results
None listed