I48.0
Conditions
Interventions
Group 1: Circumferential pulmonary vein isolation with QDOT MICRO TM catheter (90W, 4s per ablation [QMODE+])
Group 2: Circumferential pulmonary vein isolation with THERMOCOOL SMARTTOUCH® SF catheter
Sponsors
Zentrum für Kardiologie, Kardiologie II (Rhythmologie)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Paroxysmal atrial fibrillation 2. Planned pulmonary vein isolation (initial procedure). Patients who also require ablation of the cavotricuspid isthmus due to a concurrent diagnosis of atrial flutter are included
Exclusion criteria
Exclusion criteria: 1. Any previous ablation of atrial fibrillation (pulmonary vein isolation), regardless of the energy used (e.g. radiofrequency current or cryoablative procedure) 2. Contraindication to carrying out pulmonary vein isolation (e.g. one carried out immediately before the ablation thrombus in the left atrial appendage identified by transesophageal echocardiography) 3. Contraindication to performing a cranial MRI scan 4. No written consent to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedure duration (groin puncture until sheath removal), in minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: 1. Left atrial dwell time (transseptal puncture until removal of the last catheter from the left atrium), in minutes (min) 2. Fluoroscopy time (duration of fluoroscopy time over the total duration of the procedure, in seconds (s) 3. Fluoroscopy dose (dose of radiation used over the total duration of the procedure), in milligray (mGy) 4. Number of radiofrequency ablation points 5. Total duration of radiofrequency ablation, in seconds (s) 6. Tissue contact (“contact force”), in grams (g) 7. Impedance drop, in ohms (O) 8. Esophageal probe temperature alarm (temperature =39.0°C) 9. Number of esophageal probe temperature alarms (temperature =39.0°C) 10. Maximum temperature measured at the esophageal probe, in °C 11. Steam pop (audible pop + artifact on electrogram) 12. Use of a steerable (bidirectional) sheath (CARTO VIZIGO™, Biosense Webster), in n (%) 13. Acute success of pulmonary vein isolation (all pulmonary veins isolated before sheath pull), in n (%) 14. First-pass isolation (left) (the left pulmonary veins are completely isolated after the 1st circumferential ablation), in n (%) 15. First-pass isolation (right) (the right pulmonary veins are completely isolated after the 1st circumferential ablation), in n (%) 16. First-pass isolation (both sides) (the left and right pulmonary veins are completely isolated after the first circumferential ablation), in n (%) Part 2: 1. (New) pericardial effusion (>0.5 cm end-diastolic) at the end of the procedure 2. (New) pericardial effusion (>0.5 cm end-diastolic) on the 1st postprocedural day 3. Pericardial tamponade requiring medical intervention (e.g. pericardiocentesis or surgery) until discharge 4. Complications due to access route (bleeding with a drop of >2 g/dl hemoglobin or need for a transfusion of =1 packed red blood cell, hematoma requiring intervention or surgery, aneurysm spurium or AV fistula) 5. Laboratory parameters: ? BNP between baseline and the 1st postprocedural day 6. Laborat | — |
Countries
Germany
Contacts
Public ContactThomas Rostock
Zentrum für Kardiologie, Kardiologie II (Rhythmologie)
Outcome results
None listed