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

Not Applicable

Recruiting

• Conditions: Cardiac Resynchronization Therapy; Bradycardia; Left Bundle Branch Area Pacing
• Interventions: Device: Use of FLEXIGO delivery catheter

• Registration Number: NCT06453850
• Lead Sponsor: MicroPort CRM

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-29
• Study First Submitted QC: 2024-06-05
• Study First Posted: 2024-06-12
• Status Verified: 2025-02
• Study Start: 2025-02-14
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-06
• Primary Completion: 2025-07
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FLEXIGO delivery catheter	Use of FLEXIGO delivery catheter	-

Primary Outcome Measures

Name	Time	Method
Absence of Unanticipated Serious Adverse Device Effect (USADE) related to FLEXIGO delivery catheter	72 hours after implantation	Any event caused by use of the FLEXIGO delivery catheter or any accessory packaged with the catheter, will be considered as an ADE related to the FLEXIGO delivery catheter. The primary endpoint evaluation will be based on Sponsor assessment of safety events, based on investigational site reporting.

Secondary Outcome Measures

Name	Time	Method
Left Bundle Branch Area Pacing (LBBAP) implantation success rate per indication (cardiac pacing and CRT) and per ventricular pacing lead model	During implantation	- LBBAP implantation success rate with FLEXIGO delivery catheter (documented in cardiac pacing and CRT-D populations separately): Proportion of lead successfully implanted at the interventricular septum with use of the FLEXIGO delivery catheter and fulfilling LBBAP success criteria according to the operator's decision.; - LBBAP implantation success rate (overall, and documented in cardiac pacing and CRT-D populations separately): Proportion of lead successfully implanted at the interventricular septum with use of any material and fulfilling LBBAP success criteria according to the operator's decision.
Implantation success rates	During implantation	- Implantation success rate with FLEXIGO delivery catheter: Proportion of lead successfully implanted at the interventricular septum with use of the FLEXIGO delivery catheter.; - Left Bundle Branch Area Pacing (LBBAP) implantation success rate with FLEXIGO delivery catheter: Proportion of lead successfully implanted at the interventricular septum with use of the FLEXIGO delivery catheter and fulfilling LBBAP success criteria according to the operator's decision.; - LBBAP implantation success rate (overall): Proportion of lead successfully implanted at the interventricular septum with use of any material and fulfilling LBBAP success criteria.
Implantation usability	During implantation	Implantation usability of the FLEXIGO delivery catheter documented through handling scores based on a specific questionnaire addressed to the operator after implantation.
Serious Adverse Device Effect (SADE) rate related to FLEXIGO delivery catheter or the slitter	72 hours after implantation	Proportion of SADE related to the FLEXIGO delivery catheter or the slitter.
Implantation time	During implantation	Total procedural time and total fluoroscopic time documented per type of cardiac device implanted and per model of catheter used.

Trial Locations

Locations (3)

ULS de Coimbra; 🇵🇹 Coimbra, Portugal

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital Universitari i Politècnic La Fe; 🇪🇸 Valencia, Spain