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Impact of Catheter Stability on the Outcomes With Very High Power Short Duration Ablation

NCT06721221 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-12-11

No results posted yet for this study

Summary

Background: Atrial fibrillation (AF), the most common cardiac rhythm disorder can be treated with pulmonary vein isolation (PVI). One technique for PVI is point-by-point radiofrequency ablation. Very high power short duration ablation is one of the most advanced technologies for radiofrequency ablation. However, acute efficacy results with this technology vary in a wide range. Improvements in automated tagging modules, incorporating tracking of cardiac and respiratory motion and enhanced stability algorithms, may allow for a better assessment of lesion quality and location and may improve the so called first-pass isolation rate (an indicator for acute procedural efficacy).

Objective: To assess the acute procedural outcomes of very high power short duration PVI with the new enhanced stability software.

Methods: Investigator-initiated, prospective, single-arm study on one hundred symptomatic patients with paroxysmal AF will undergo PVI with the QDOT catheter using a power setting of 90W(QMODE+). The inter-tag distance will be 6 mm posteriorly and 4 mm anteriorly, and the enhanced stability algorithm will be used in all cases. After creating the isolation circle, the presence or absence of first-pass isolation will be assessed on each side by the presence of entrance block. Primary endpoint will be first-pass isolation rate. Secondary outcomes are as follows: procedure time, left atrial dwell time, RF time, number of RF tags, use of a steerable sheath, occurrence of serious adverse events.

Hypothesis: Very high power short duration PVI using the new stability software results in a higher rate of first-pass isolation than previously published.

Conditions

  • Atrial Fibrillation (AF)
  • Atrial Fibrillation Ablation
  • Pulmonary Vein Isolation

Interventions

DEVICE

Point-by-point PVI with the QDot Micro catheter in QMODE+ setting with the Svtag software

PVI will be performed via femoral access after transseptal puncture, guided by fluoroscopy pressure monitoring, intracardiac echocardiography (ICE) or transesophageal echocardiography (TEE). A fast anatomical left atrial map will be created; then, point-by-point PVI will be performed with QDot Micro catheter in QMODE plus with the Svtag software. Inter-tag distance should be ≤ 6 mm on the posterior wall and ≤ 4 mm on the anterior wall. All applications' duration should be 4 seconds. After creating the isolation circle, the presence or absence of first-pass isolation will be assessed on each side by the presence of entrance block. If PVI is complete, this is defined as first-pass isolation. If PVI is not complete at this point, touch-up lesions will be delivered to reach the isolation of all pulmonary veins. After that, acute PV reconnections will be evaluated during a 20 minutes waiting period.

Sponsors & Collaborators

  • Semmelweis University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06721221 on ClinicalTrials.gov