abnormal heart rhythm atrial flutter
Conditions
Interventions
The Adagio Cryoablation System consist of the Cryoablation ablation catheter
and a Cryoablation console. The Adagio Cryoablation System creates cryothermy
energy by pressurizing nitrogen to critical
Sponsors
Biotechnologische Industrie
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Two symptomatic episodes of typical AFl (or chronic atrial flutter) during the one-year period prior to enrollment. This may include typical AFl occurring while receiving AAD therapy for non-AFl tachyarrhythmia, including AFl.
Exclusion criteria
Exclusion criteria: Intra-cardiac thrombus has not been eliminated in subjects exposed to less than 4 weeks of therapeutic anticoagulation and a TEE (trans-esophageal echocardiogram) and/or CT scan did not conclusively rule out thrombus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Percentage of subjects experiencing cardiovascular specific adverse events (CSAE) within thirty 30 days of the ablation procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| *Acute Success: Percentage of subjects with termination of AFL and complete bidirectional conduction block across the subeustachian (cavo-*tricuspid) isthmus at the end of the ablation procedure. *Outcome success: Percent of subjects with absence of AFl at 180 days. | — |
Countries
Netherlands
Outcome results
None listed