Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05996159 |
| Other study ID # |
Q-INDEX |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2023 |
| Est. completion date |
September 30, 2026 |
Study information
| Verified date |
July 2023 |
| Source |
Seoul National University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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.
