Health TrialsbyHealthPanel

Pulmonary Vein Isolation Strategy of Very High Power Short Duration in Patients With Paroxysmal Atrial Fibrillation

ConditionParoxysmal Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSeoul National University Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing PVI for PAF

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • QDOT MicroTM catheter

    Device

    Novel high power-short duration ablation catheter for atrial fibrillation

  • AI-guided ablation only for PVI

    Device

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

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: vHPSD ablation only for PVIExperimental treatment 1 intervention
Group B: vHPSD and AI-guided ablation for PVIExperimental treatment 2 interventions
Group C: AI-guided ablation only for PVIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Time for AF ablation

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

Time frame
up to 12 months

Secondary outcomes

1

Acute PV reconnection rate

Including residual PV potential and early reconnection after 1st pass PVI.

Time frame
up to 12 months
2

The segment of residual PV potential

Descript as RSPV roof/anterior/posterior/carina, RIPV anterior/posterior/inferior/carina, LSPV roof/anterior(ridge)/posterior/carina, LIPV anterior(ridge)/posterior/inferior/carina.

Time frame
up to 12 months
3

The segment of early reconnection

Descript as RSPV roof/anterior/posterior/carina, RIPV anterior/posterior/inferior/carina, LSPV roof/anterior(ridge)/posterior/carina, LIPV anterior(ridge)/posterior/inferior/carina.

Time frame
up to 12 months
4

1-year AF recurrence

Using single lead 3-day holter monitoring.

Time frame
up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Hospital

Lead sponsor

Source ClinicalTrials.gov
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