I48
Conditions
Interventions
Group 1: Pulmonary vein isolation using a reprocessed single-use catheter (Thermocool Smarttouch, Tacticath or Arctic Front)
Sponsors
VANGUARD AG
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Patients with • drug refractory paroxysmal atrial fibrillation, or • paroxysmal atrial fibrillation who prefer catheter ablation as first line therapy, or • drug refractory persistent atrial fibrillation w/o major risk factors for AF recurrence who are eligible for pulmonary vein isolation according to current guidelines • patients returning for their first repeat ablation after AF recurrence 2. Female and male patients aged 18-85 years 3. Planned treatment with Vanguard-reprocessed Tacticath, Tactiflex, Smart Touch, or Arctic Front catheters 4. Informed consent in writing from patient
Exclusion criteria
Exclusion criteria: 1. Patients with congenital heart disease 2. Patients with heart failure NYHA class > II and/or LVEF < 35% 3. Patients who, in the opinion of the Principal Investigator, are unlikely to comply with the protocol requirements, instructions and trial related restrictions, e.g., uncooperative attitude, inability to return for follow-up visits, psychological illness, and improbability of completing the trial. 4. Vulnerable Patients (e.g. patients requiring a legal representative, patients kept in detention, any service within the army, and employees of the sponsor or at an investigator site). 5. Repeat ablation for atrial tachycardia or patients who already underwent a repeat ablation 6. Patients with intracardiac thrombus 7. Patients who have undergone a ventriculostomy or atriotomy in the preceding four weeks 8. Patients with heart valve prosthesis 9. Patients with active systemic infection 10. Patients who have shown sensitivity to foreign objects in the past or who have an allergy 11. Patients with severe anomalies in the heart and/or blood vessels (transposition) and obstruction 12. Patients with myxoma of the left atrium, interatrial variations or interatrial baffle or patch 13. Any additional contraindications for treatment with Tacticath Quartz, Thermocool Smart Touch or Arctic Front Advance catheters, according to current IFU 14. Planned cardiac intervention besides AF ablation within the next 12 months 15. Participation in any study of an investigational device or drug within 90 days prior or during this study. 16. Prior participation in the current study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of intra-procedural SADEs at index ablation (SAE reports) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Rate of device-related and procedure-related SADEs over 12 months (SAE reports) • Number of repeat ablations within three months (CRF, patient records) • AF recurrence between 3 and 12 months (CRF, patient records) • Need for antiarrhythmic drugs between 3 and 12 months (CRF, patient records) • Need for re-interventions between 3 and 12 months (CRF, patient records) • Need for (N)OAC between 3 and 12 months (CRF, patient records) • Clinical Symptoms (CRF, patient records) • Quality of Life 3 and 12 months (SF-36 Questionnaire) | — |
Countries
Germany
Contacts
Public ContactClaus Heinrich
Vanguard AG
Outcome results
None listed