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COMPLETED
NCT06453850
NA

Safety and Performance Evaluation of a New Catheter Range for Lead Implantation at Interventricular Septum

Sponsor: MicroPort CRM

View on ClinicalTrials.gov

Summary

The purpose of the clinical investigation is to evaluate the safety of the FLEXIGO delivery catheter for transvenous pacing lead implantation.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

216

Start Date

2025-02-14

Completion Date

2026-04-30

Last Updated

2026-09-23

Healthy Volunteers

No

Interventions

DEVICE

Use of FLEXIGO delivery catheter

Use of FLEXIGO delivery catheter for implantation of ventricular pacing lead

Locations (17)

Centre Hospitalier Annecy Genevois

Annecy, France

CHU Clermont-Ferrand

Clermont-Ferrand, France

Clinique du Millénaire

Montpellier, France

CHU Rouen Hôpital Charles Nicolle

Rouen, France

Herz- und Gefäßzentrum Bad Bevensen

Bad Bevensen, Germany

Arcispedale Sant'Anna - AO Univ.

Ferrara, Italy

Ospedale Maggiore della Carità - AO Univ.

Novara, Italy

Ospedale SS Annunziata

Taranto, Italy

Ospedale Ca' Foncello

Treviso, Italy

ULS de Coimbra

Coimbra, Portugal

ULS Lisboa Ocidental - Hospital de Santa Cruz

Lisbon, Portugal

ULS Santa Maria

Lisbon, Portugal

Hospital Universitari de Girona Doctor Josep Trueta

Girona, Spain

Hospital Universitario Virgen de las Nieves

Granada, Spain

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, Spain

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Spain

Hospital Universitari i Politècnic La Fe

Valencia, Spain