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PulseSelect Based Pulmonary Vein Isolation and Ablation in Patients With Atrial Fibrillation

NCT07035288 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-09-25

No results posted yet for this study

Summary

Electroanatomical mapping (EAM) based pulmonary vein isolation (PVI) by means of PulseSelect catheter and deep sedation will be compared to fluoroscopy based pulmonary vein isolation in patients with atrial fibrillation in the acute and long term (2 months remapping).

Conditions

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

Interventions

DEVICE

EAM based Pulmonary Vein Isolation

20 patients with symptomatic paroxysmal or persistent AF will be scheduled for pulmonary vein isolation (PVI) based to EAM by means of the PulseSelect catheter. Ablation will be performed in a deep sedation setting and additional ablation within the pulmonary veins will be assessed

DEVICE

Fluoro based pulmonary vein ablation

20 patients with symptomatic paroxysmal or persistent AF will be scheduled for pulmonary vein isolation (PVI) based to Fluoroscopy by means of the PulseSelect catheter. Ablation will be performed in a deep sedation setting and additional ablation within the pulmonary veins will be assessed

Sponsors & Collaborators

  • Medtronic Atrial Fibrillation Solutions

    collaborator INDUSTRY

  • Tsiachris Dimitrios

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-06-30
Completion
2025-07-10

Countries

  • Greece

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 NCT07035288 on ClinicalTrials.gov