Pulmonary Vein Isolation Strategy of Very High Power Short Duration in Patients With Paroxysmal Atrial Fibrillation: Q-INDEX Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study aims to investigate the effect of reducing ablation time for a hybrid approach of vHPSD and AI-guided ablation using the QDOT Micro catheter in PVI among patients with PAF.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• Patients undergoing PVI for PAF

Locations
Other Locations
Republic of Korea
Seoul National University Hospital
RECRUITING
Seoul
Contact Information
Primary
Eue-Keun Choi, M.D. Ph.D.
choiek417@gmail.com
82-2-2072-0688
Time Frame
Start Date: 2023-11-07
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 150
Treatments
Experimental: vHPSD ablation only for PVI
Pulmonary vein encirclement is achieved using contiguous applications of very high power and short duration (90 W over 4 seconds). The inter-lesion distance is set at 3-4mm for the roofs and anterior segments, and 5-6mm for other segments. If the esophageal temperature rises \> 38 for segments near the esophagus, encirclement will be applied at 25 W for 15 seconds.
Experimental: vHPSD and AI-guided ablation for PVI
At the anterior segments, pulmonary vein encirclement is achieved through contiguous applications using AI-guided ablation (40-50 W, AI target 500, and an inter-lesion distance of 4mm).~In the other segments, pulmonary vein encirclement is achieved through contiguous applications using very high-power and short-duration techniques (90 W over 4 seconds, inter-lesion distance of 3-4mm; if the segments are near the esophagus, encirclement will be applied at 25 W for 15 seconds).
Experimental: AI-guided ablation only for PVI
Pulmonary vein encirclement is achieved through contiguous applications using AI-guided ablation (40-50 W, AI target 500 for anterior segments and 400 for other segments, with an inter-lesion distance of 4mm; if the segments are near the esophagus, encirclement will be applied at 25 W for 15 seconds)
Related Therapeutic Areas
Sponsors
Leads: Seoul National University Hospital

This content was sourced from clinicaltrials.gov