Health TrialsbyHealthPanel

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

ConditionsBradycardiaCardiac Resynchronization TherapyLeft Bundle Branch Area Pacing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMicroPort CRM

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 catheter-guided implantation in the interventricular septum area

Patient planned for the implantation of any CE marked ventricular pacing lead compatible with the FLEXIGO delivery catheter

Disqualifiers

Patient planned for a device upgrade, or a device or a lead replacement

Patient with a congenital heart disease

Patient with significant hypertrophic cardiomyopathy, cardiac amyloidosis or obstructive hypertrophic cardiomyopathy

Patient with a Left Ventricular Ejection Fraction (LVEF) ≤ 35%

Trial design

Design model

Single group

Treatments tested in this trial

  • Use of FLEXIGO delivery catheter

    Device

    Use of FLEXIGO delivery catheter for implantation of ventricular pacing lead

Treatment groups

216 Participants
are divided into 1 treatment group
Group A: FLEXIGO delivery catheterExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Absence of Unanticipated Serious Adverse Device Effect (USADE) related to FLEXIGO delivery catheter

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.

Time frame
72 hours after implantation

Secondary outcomes

1

Implantation success rates

\- 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.

Time frame
During implantation
2

Implantation time

Total procedural time and total fluoroscopic time documented per type of cardiac device implanted and per model of catheter used.

Time frame
During implantation
3

Implantation usability

Implantation usability of the FLEXIGO delivery catheter documented through handling scores based on a specific questionnaire addressed to the operator after implantation.

Time frame
During implantation
4

Serious Adverse Device Effect (SADE) rate related to FLEXIGO delivery catheter or the slitter

Proportion of SADE related to the FLEXIGO delivery catheter or the slitter.

Time frame
72 hours after implantation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MicroPort CRM

Lead sponsor

Source ClinicalTrials.gov
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