Recruiting NCT06453850

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

No phase Interventional Bradycardia Cardiac Resynchronization Therapy Left Bundle Branch Area Pacing

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Use of FLEXIGO delivery catheter.
Who it may be relevant to: Registry conditions: Bradycardia, Cardiac Resynchronization Therapy, Left Bundle Branch Area Pacing. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Portugal, Spain
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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

Device Use of FLEXIGO delivery catheter
Use of FLEXIGO delivery catheter for implantation of ventricular pacing lead

Absence of Unanticipated Serious Adverse Device Effect (USADE) related to FLEXIGO delivery catheter [Time frame: 72 hours after implantation]

Secondary outcome measures (5)

Implantation success rates [Time frame: During implantation]
Implantation time [Time frame: During implantation]
Implantation usability [Time frame: During implantation]
Serious Adverse Device Effect (SADE) rate related to FLEXIGO delivery catheter or the slitter [Time frame: 72 hours after implantation]
Left Bundle Branch Area Pacing (LBBAP) implantation success rate per indication (cardiac pacing and CRT) and per ventricular pacing lead model [Time frame: During implantation]

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 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
Patient reviewed, signed and dated the Informed Consent Form (ICF)

Inclusion criteria (phase II):

Patient indicated for cardiac pacing or CRT according to the most recent guidelines from the ESC
Patient planned for a de novo implantation of any SR or DR CE marked pacemaker, or any CE marked CRT-D
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
Patient reviewed, signed and dated the ICF

Exclusion criteria (phase I):

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%
Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device)
Patient implanted despite a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient contraindicated for a single dose of 310 μg of dexamethasone sodium phosphate, patient implanted with a tricuspid replacement heart valve, with prior tricuspid valve intervention or with a significant tricuspid valve disease that may lead to future replacement heart valve surgery)
Minor age patient (i.e. under 18 years of age)
Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation
Non-menopausal women

Exclusion criteria (phase II):

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 already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device)
Patient implanted despite a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient contraindicated for a single dose of 310 μg of dexamethasone sodium phosphate, patient implanted with a tricuspid replacement heart valve, with prior tricuspid valve intervention or with a significant tricuspid valve disease that may lead to future replacement heart valve surgery)
Minor age patient (i.e. under 18 years of age)
Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation
Non-menopausal women

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Spain · 2 centers

Portugal · 1 center

NCT: NCT06453850 · DARI01 - POLARIS