Safety and Performance Evaluation of a New Catheter Range for Lead Implantation At Interventricular Septum
NCT06453850 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 216
Last updated 2025-03-06
Summary
The purpose of the clinical investigation is to evaluate the safety of the FLEXIGO delivery catheter for transvenous pacing lead implantation.
Conditions
- Bradycardia
- Cardiac Resynchronization Therapy
- Left Bundle Branch Area Pacing
Interventions
- DEVICE
-
Use of FLEXIGO delivery catheter
Use of FLEXIGO delivery catheter for implantation of ventricular pacing lead
Sponsors & Collaborators
-
MicroPort CRM
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-14
- Primary Completion
- 2025-07-31
- Completion
- 2026-12-31
Countries
- Portugal
- Spain
Study Locations
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