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Efficacy Comparison of High and Very High Power Short Duration Pulmonary Vein Isolation

NCT05459831 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-11-15

No results posted yet for this study

Summary

Objective: To evaluate the long-term durability of PVI performed with 90W and 50W (QDot catheter).

Primary hypothesis: Pulmonary vein isolation performed with 90W (QMODE+) and inter-tag distance \<5 mm is non-inferior to pulmonary vein isolation performed with 50W guided by ablation index (QMODE) and inter-tag distance \<5 mm.

Study Design: 40 patients will be randomized in a 1:1 ratio to 50W and 90W PVI.

Study procedures: Initial PVI will be performed via femoral access and double transseptal puncture guided by fluoroscopy and pressure monitoring. If necessary intracardiac echocardiography (ICE) will be used for the transseptal puncture. A fast anatomical left atrial map will be created with a multipolar mapping catheter; then, point-by-point PVI will be performed with QDot catheter with 50W or 90W according to randomization. Three months after the initial procedure, patients will undergo a repeated high density left atrial mapping with PentaRay or OctaRay catheter to evaluate the durability of the PVI. Exact gap numbers and locations will be registered. If necessary, reablation of the pulmonary veins (rePVI) will be performed.

Inclusion criteria: Symptomatic paroxysmal/persistent AF, \>18 years, willingness to sign informed consent form.

Exclusion criteria: Long-standing persistent AF, active malignancy, contraindication for anticoagulant therapy, life expectancy \<1 year, valvular AF, hyperthyroidism.

Endpoints: At repeat procedure, a high density left atrial map will be created with PentaRay or if available OctaRay catheter to evaluate the durability of the PVI. Primary endpoint will be pulmonary vein reconnection.

Conditions

Interventions

DEVICE

QDot Micro Catheter

Atrial fibrillation radiofrequency ablation with 90W or 50W energy setting.

Sponsors & Collaborators

  • Semmelweis University

    lead OTHER

Principal Investigators

  • László Gellér, Ph.D., DSc · Semmelweis University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-15
Primary Completion
2022-12-01
Completion
2023-10-01

Countries

  • Hungary

Study Locations

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Entities

Diseases

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 NCT05459831 on ClinicalTrials.gov