Persistent Atrial Fibrillation
Conditions
Keywords
Smart-Touch, Contact force
Brief summary
This prospective, randomized study will investigate, if information of the catheter force during ablation of a left anterior line does reduce total RF application time by prevention of ineffective lesions.
Detailed description
Catheter ablation has emerged as a realistic therapeutic option for symptomatic atrial fibrillation (AF). The three main techniques described for ablation of persistent AF include pulmonary vein (PV) isolation, ablation based on electrogram analysis, and left atrial (LA) linear lesions. The ideal endpoint of linear lesions should be complete electrical block; however, this is technically challenging, time consuming, and potentially hazardous. The ST catheter combined with 3D mapping and navigation software, gives physicians a real-time, objective measure of tip-to-tissue contact force during the catheter ablation procedure and will allow physicians to more safely and effectively treat atrial fibrillation.
Interventions
DEVICEThermocool Smart Touch Catheter
Physician informed to contact force
Sponsors
LMU Klinikum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with symptomatic atrial fibrillation and additional substrate modification or perimitral flutter * Patients with persistent atrial fibrillation * Patients with perimitral flutter * Patients with recurrence after a circumferential PV isolation procedure * Patients with paroxysmal atrial fibrillation and AF episodes lasting \> 7 days * Patients (\>18 und \<80 Jahre)
Exclusion criteria
* moderate to severe valvular heart disease, * congenital heart disease * reduced left ventricular function (ejection fraction \<35%) * any reversible cause for atrial fibrillation (e.g. hyperthyroidism) * intracardiac thrombi documented by transesophageal echocardiography * myocardial infarction within 3 months, cardiac surgery in the previous three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of total RF application until bidirectional conduction block across the anterior line is achieved (including a waiting period of 30 minutes) | 30 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of primary endpoint (bidirectional conduction block at an anterior line) | 6 months | Achievement of primary endpoint (bidirectional conduction block at an anterior line). Procedure Duration. Reduction of local potential amplitude during SR or atrial fibrillation after 60 seconds of ablation. Freedom of any atrial tachyarrhythmia at 7 day holter 3 and 6 months after a single ablation procedure. Freedom of any symptoms of atrial arrhythmias 6 months after ablation (except during blanking period of 6 weeks). Confirmation of gap-freeness in MRI (3-6 months after ablation). Quality of Life (atrial fibrillation symptom checklist und major depression index) pre, 3 and 6 months after Ablation. Safety (bleeding, pericardial effusion, thrombembolic events). |
Countries
Germany
Outcome results
None listed