Impact of Catheter Stability on the Outcomes With Very High Power Short Duration Ablation

NAActive, not recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

August 1, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Atrial Fibrillation (AF)Atrial Fibrillation AblationPulmonary Vein Isolation
Interventions
DEVICE

Point-by-point PVI with the QDot Micro catheter in QMODE+ setting with the Svtag software

PVI will be performed via femoral access after transseptal puncture, guided by fluoroscopy pressure monitoring, intracardiac echocardiography (ICE) or transesophageal echocardiography (TEE). A fast anatomical left atrial map will be created; then, point-by-point PVI will be performed with QDot Micro catheter in QMODE plus with the Svtag software. Inter-tag distance should be ≤ 6 mm on the posterior wall and ≤ 4 mm on the anterior wall. All applications' duration should be 4 seconds. After creating the isolation circle, the presence or absence of first-pass isolation will be assessed on each side by the presence of entrance block. If PVI is complete, this is defined as first-pass isolation. If PVI is not complete at this point, touch-up lesions will be delivered to reach the isolation of all pulmonary veins. After that, acute PV reconnections will be evaluated during a 20 minutes waiting period.

Trial Locations (1)

1122

Heart and Vascular Center, Semmelweis University, Budapest

All Listed Sponsors
lead

Semmelweis University

OTHER

NCT06721221 - Impact of Catheter Stability on the Outcomes With Very High Power Short Duration Ablation | Biotech Hunter | Biotech Hunter