Seoul National University Hospital
Seoul, South Korea
Location status: Recruiting
NCT Number: NCT05996159
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.
Interested in participating?
Request Info19 year and older
All sexes
Interventional
Not applicable
Seoul, South Korea
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Novel high power-short duration ablation catheter for atrial fibrillation
Ablation is the removal or destruction of something from an object by vaporization, chipping, erosive processes, or by other means.
Time frame: up to 12 months
Including total PVI time, total ablation time, fluoroscopic time, and total procedure time.
Time frame: up to 12 months
Including residual PV potential and early reconnection after 1st pass PVI.
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.
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.
Time frame: up to 12 months
Using single lead 3-day holter monitoring.
Time frame: up to 12 months
Including puncture site hematoma, puncture site pseudoaneurysm, puncture site AV fistula, stroke, TIA, thromboembolism, and others.
Contact information is provided by the study sponsor or research team.
Seoul National University Hospital
Other
Pulmonary Vein Isolation Strategy of Very High Power Short Duration in Patients With Paroxysmal Atrial Fibrillation: Q-INDEX Trial
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.
Published trials that share one or more normalized conditions with this study.
NCT07116525
Arrhythmias, Cardiac, Atrial Fibrillation
Bruges, Belgium
View Trial DetailsNCT07444320
Arrhythmias, Cardiac, Atrial Fibrillation
Split, Croatia
View Trial DetailsNCT05227053
Arrhythmias, Cardiac, Atrial Fibrillation
Anchorage, Alaska, United States
View Trial DetailsNCT04088071
Arrhythmias, Cardiac, Atrial Fibrillation
Birmingham, Alabama, United States
View Trial Details