臨床研究等提出・公開システム

PulseSelect PFA System Japan PMS

PulseSelect PFA System Japan PMS

SAKURAI Shigeaki

Medtronic Japan

Shinagawa Season Terrace, 1-2-70 Konan, Minato-ku, Tokyo

sakurs2@medtronic.com

SAKURAI Shigeaki

Medtronic Japan

Shinagawa Season Terrace, 1-2-70 Konan, Minato-ku, Tokyo

+81-3-6776-1406

sakurs2@medtronic.com

Not Recruiting

Oct. 15, 2024

Observational

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.

None

Both

Drug refractory, recurrent, symptomatic paroxysmal/persistent atrial fibrillation

<Safety endpoints>
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

<Effectiveness endpoint>
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

No

none