NCT05996159

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Nov 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress73%
Nov 2023May 2027

First Submitted

Initial submission to the registry

August 1, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

November 7, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

May 20, 2026

Status Verified

May 1, 2025

Enrollment Period

2.7 years

First QC Date

August 1, 2023

Last Update Submit

May 18, 2026

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Time for AF ablation

    Including total PVI time, total ablation time, fluoroscopic time, and total procedure time.

    up to 12 months

Secondary Outcomes (5)

  • Acute PV reconnection rate

    up to 12 months

  • The segment of residual PV potential

    up to 12 months

  • The segment of early reconnection

    up to 12 months

  • 1-year AF recurrence

    up to 12 months

  • 30-day complication associated with procedure

    up to 12 months

Study Arms (3)

vHPSD ablation only for PVI

EXPERIMENTAL

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.

Device: QDOT MicroTM catheter

vHPSD and AI-guided ablation for PVI

EXPERIMENTAL

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).

Device: QDOT MicroTM catheterDevice: AI-guided ablation only for PVI

AI-guided ablation only for PVI

EXPERIMENTAL

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)

Device: AI-guided ablation only for PVI

Interventions

QDOT MicroTM catheterDEVICE

Novel high power-short duration ablation catheter for atrial fibrillation

vHPSD ablation only for PVIvHPSD and AI-guided ablation for PVI
AI-guided ablation only for PVIDEVICE

Ablation is the removal or destruction of something from an object by vaporization, chipping, erosive processes, or by other means.

AI-guided ablation only for PVIvHPSD and AI-guided ablation for PVI

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing PVI for PAF

You may not qualify if:

  • Aged less than 19 years
  • Patients with persistent AF
  • Patients with previous ablation or surgery for AF
  • Patients with intracardiac thrombus or thromboembolic events within the previous 90 days
  • Patients with cardiac surgery or acute coronary syndrome within the previous 90 days
  • Patients with contraindication(s) for using oral anticoagulants
  • Patients with LA anteroposterior diameter of more than 55 mm
  • Patients with left ventricular ejection fraction less than 35%
  • Pregnants or those who plan to become pregnant during the study
  • Life expectancy less than a year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Eue-Keun Choi, M.D. Ph.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eue-Keun Choi, M.D. Ph.D.

CONTACT

82-2-2072-0688choiek417@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2023

First Posted

August 18, 2023

Study Start

November 7, 2023

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

May 20, 2026

Record last verified: 2025-05

Locations

KR(1)