Safety and Performance Evaluation of a New Catheter Range for Lead Implantation At Interventricular Septum
Recruiting
N/A
Interventional Study
Bradycardia
Cardiac Resynchronization Therapy
Left Bundle Branch Area Pacing
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 216 (estimated)
- Sponsor
- MicroPort CRM · Industry
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About This Trial
The purpose of the clinical investigation is to evaluate the safety of the FLEXIGO delivery catheter for transvenous pacing lead implantation.
Trial Locations
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Eligibility Criteria
Inclusion criteria (phase I):
* Patient indicated for cardiac pacing according to the most recent guidelines from the European Society of Cardiology (ESC)
* Patient planned for a de novo implantation of any Single Chamber (SR) or Dual Chamber (DR) CE marked pacemaker
* Patient planned for a cathete…
Contacts