Drug refractory, recurrent, symptomatic paroxysmal/persistent atrial fibrillation
Conditions
Interventions
None listed
Sponsors
SAKURAI Shigeaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The surveillance will include cases in which cardiac electrophysiological mapping and treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation or drug refractory, symptomatic persistent atrial fibrillation are performed using the product. Cases will be considered eligible for the surveillance when the product is inserted into the body at the facility where the surveillance is conducted.
Exclusion criteria
Exclusion criteria: None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence rate of the primary safety events defined below (product related and ablation PFA procedure-related serious adverse events) and evaluation of each event Within 6 months post-ablation: - Pulmonary vein stenosis requiring intravascular treatment/surgical procedure - Phrenic nerve injury/diaphragmatic paralysis (ongoing at 6 months) - Atrioesophageal fistula Within 30 days of ablation procedure: - Cardiac tamponade/perforation - Cerebrovascular accident - Major bleeding requiring transfusion - Myocardial infarction - Pericarditis requiring intervention (hospitalization/extended hospitalization for more than 48 hours/requiring pericardiocentesis) - Transient ischemic attack - Vagal nerve injury resulting in esophageal dysmotility or gastroparesis - Hematoma requiring surgical treatment - AV fistula (hospitalization/extended hospitalization /requiring any kind of treatment) - pseudoaneurysm (hospitalization/extended hospitalization /requiring any kind of treatment) - Systemic/pulmonary embolism requiring intervention (hospitalization/extended hospitalization for more than 48 hours/requiring any kind of treatment) - Pulmonary edema - Death Treatment success rate during the first 12 months after surgery Treatment success is defined as freedom from treatment failure. Patients treated for AF will be counted as an effectiveness failure if any of the following are documented >= 91 days after the index ablation procedure: - Documented AF, AT, or AFL lasting 30 seconds or more on a cardiac rhythm monitoring device (or 10 seconds on a 12-lead ECG) - Repeat atrial ablation for the treatment of AF/AFL/AT - Pharmacological or electrical cardioversion for the treatment of AF/AFL/AT | — |
Contacts
Public ContactShigeaki SAKURAI
Medtronic Japan
Outcome results
None listed