Safety and Performance Evaluation of a New Catheter Range for Lead Implantation At Interventricular Septum
NCT ID: NCT06453850
Last Updated: 2025-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
216 participants
INTERVENTIONAL
2025-02-14
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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FLEXIGO delivery catheter
Use of FLEXIGO delivery catheter
Use of FLEXIGO delivery catheter for implantation of ventricular pacing lead
Interventions
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Use of FLEXIGO delivery catheter
Use of FLEXIGO delivery catheter for implantation of ventricular pacing lead
Eligibility Criteria
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Inclusion Criteria
* 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)
* 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
* 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
* 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
18 Years
ALL
No
Sponsors
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MicroPort CRM
INDUSTRY
Responsible Party
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Locations
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ULS de Coimbra
Coimbra, , Portugal
Hospital Universitario Virgen de las Nieves
Granada, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DARI01 - POLARIS
Identifier Type: -
Identifier Source: org_study_id
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