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NCT Number: NCT05996159

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Eue-Keun Choi, MD, PhD

CONTACT

[email protected]

About this study

Radiofrequency catheter ablation has become a cornerstone strategy for the rhythm control of AF. During the last decade, catheter technology has revolutionized and, accordingly, clinical outcomes after the ablation and procedural efficacy have been improved.

In recent years, the use of the CLOSE protocol employing contiguous, closely spaced applications and targeted ablation index (AI) values has translated into robust acute and long-term success rates for PVI, typically with the power delivery of up to 35 W, and more recently with 40 to 50 W, in power and temperature-controlled mode.

Contiguous ablation using very high-power, short-duration ablation at 90 W over 4 seconds is expected to shorten procedure time. However, changes in lesion geometry and the altered impact of catheter stability on lesion quality may influence procedural efficiency, safety, and effectiveness.

The Q-FFICIENCY trial showed that the vHPSD (90 W, 4 sec), temperature-controlled radiofrequency ablation (25/50 W) has comparable efficacy to conventional-power temperature-controlled ablation.

However, the efficacy of vHPSD ablation may depend on PV thickness due to its lesion characteristics. Therefore, AI-guided ablation may have merits over vHPSD ablation in thickened PV segments. According to the POWER PLUS trial, the proportion of 1st-pass PVI with vHPSD ablation was numerically lower than that of the conventional ablation, although there was marginal significance; 83.9% vs. 90.0%, p-value =0.085.

According to the OPTIMUM trial, a study conducted by our group, roof and anterior walls of the left atrium often require higher AI targets due to their thickness.

Therefore, a hybrid approach that combines both vHPSD and AI-guided ablations according to PV segments may achieve both high efficacy and short ablation time for PVI. The investigators of the POWER PLUS trial also speculated that the hybrid approach based on tissue thickness might offer the optimal balance of procedural efficacy.

However, up to date, no studies have investigated the efficacy and safety of the hybrid approach for PVI. More data is needed to suggest that the hybrid approach could be useful for PVI.

Therefore, 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing PVI for PAF

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Time for AF ablation

    Time frame: up to 12 months

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

Secondary outcomes

  1. Acute PV reconnection rate

    Time frame: up to 12 months

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

  2. The segment of residual PV potential

    Time frame: up to 12 months

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

  3. The segment of early reconnection

    Time frame: up to 12 months

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

  4. 1-year AF recurrence

    Time frame: up to 12 months

    Using single lead 3-day holter monitoring.

  5. 30-day complication associated with procedure

    Time frame: up to 12 months

    Including puncture site hematoma, puncture site pseudoaneurysm, puncture site AV fistula, stroke, TIA, thromboembolism, and others.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

82-2-2072-0688

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Aug 18, 2023
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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