Arrhythmias, Cardiac, Atrial Tachycardia, Heart Arrhythmia, Heart Diseases
Conditions
Keywords
Atrial fibrillation, Atrial tachycardia, Pulmonary vein isolation, Electroanatomical mapping, High density mapping
Brief summary
Ablation of consecutive atrial tachycardia (AT) after ablation of atrial fibrillation (AF) or cardiac surgery can be challenging due to complex substrate and AT mechanisms. A substantial portion of patients is known to show various tachycardias and recurrences occur in a noticeable number of cases. With the availability of novel ultra-high-density mapping techniques characterization and understanding of AT mechanisms and underlying substrate can be improved. Aim of this prospective, multi-center, randomized study is to compare a standard AT ablation approach versus minimalized ablation of the clinical AT in regards to arrhythmia free survival.
Interventions
PROCEDURECatheter ablation
Catheter-based ablation of arrhythmias using radiofrequency.
Sponsors
Evangelical Hospital Düsseldorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Consecutive AT subsequent to prior AF ablation procedure or cardiac surgery * Surface ECG-documentation of AT as primary clinical arrhythmia * ECG indicating stable, map-able AT (stable activation sequence, and CL stability) with cycle length ≥ 200ms
Exclusion criteria
* \< 18 years * No previous atrial fibrillation ablation procedure or cardiac surgery * Pregnant women or women of childbearing potential without a negative pregnancy test within 48 hours prior to treatment * History of hemorrhagic diathesis or other coagulopathies * Contraindications for oral anticoagulation * Hyper- or hypothyroidism * Has any condition that would make participation not be in the best interest of the subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence of any sustained arrhythmia (>30 sec.) | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inducibility of atrial tachycardia (AT) after ablation of clinical/primary AT (partial success) | Intraprocedural | Categorical variable (yes/no) |
| Predictability of secondary AT by analysis of clinical AT map and voltage map | Intraprocedural | — |
| Procedure duration time | Intraprocedural | — |
| Fluoroscopy time | intraprocedural | — |
| Total radiofrequency application time | intraprocedural | — |
| Ablated area (cm2) | intraprocedural | — |
| Number of blocked lines | intraprocedural | — |
| Area of low voltage in sinus map (cm2) | Intraprocedural | — |
Countries
Germany
Contacts
CONTACTChristian Meyer, MD
PRINCIPAL_INVESTIGATORChristian Meyer, MD
Evangelic Hospital Düsseldorf
Outcome results
None listed