Safety and Performance Evaluation of a New Catheter Range for Lead Implantation at Interventricular Septum (POLARIS)
The purpose of the clinical investigation is to evaluate the safety of the FLEXIGO delivery catheter for transvenous pacing lead implantation.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Annecy, Frankrike
- Centre Hospitalier Annecy Genevois
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Clermont-Ferrand, Frankrike
- CHU Clermont-Ferrand
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Montpellier, Frankrike
- Clinique du Millénaire
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Rouen, Frankrike
- CHU Rouen Hôpital Charles Nicolle
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Ferrara, Italia
- Arcispedale Sant'Anna - AO Univ.
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Novara, Italia
- Ospedale Maggiore della Carità - AO Univ.
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Taranto, Italia
- Ospedale SS Annunziata
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Treviso, Italia
- Ospedale Ca' Foncello
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Coimbra, Portugal
- ULS de Coimbra
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Lisbon, Portugal
- ULS Santa Maria
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Lisbon, Portugal
- ULS Lisboa Ocidental - Hospital de Santa Cruz
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Girona, Spania
- Hospital Universitari de Girona Doctor Josep Trueta
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Granada, Spania
- Hospital Universitario Virgen de las Nieves
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Las Palmas de Gran Canaria, Spania
- Hospital Universitario de Gran Canaria Doctor Negrín
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Murcia, Spania
- Hospital Clínico Universitario Virgen de la Arrixaca
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Valencia, Spania
- Hospital Universitari i Politècnic La Fe
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Bad Bevensen, Tyskland
- Herz- und Gefäßzentrum Bad Bevensen
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: FLEXIGO leveringskateter
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Use of FLEXIGO delivery catheter for implantation of ventricular pacing lead |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Absence of Unanticipated Serious Adverse Device Effect (USADE) related to FLEXIGO delivery catheter
Tidsramme: 72 hours after implantation
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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. |
72 hours after implantation
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Implantation success rates
Tidsramme: During implantation
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- 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. |
During implantation
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Implantation time
Tidsramme: During implantation
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Total procedural time and total fluoroscopic time documented per type of cardiac device implanted and per model of catheter used. |
During implantation
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Implantation usability
Tidsramme: During implantation
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Implantation usability of the FLEXIGO delivery catheter documented through handling scores based on a specific questionnaire addressed to the operator after implantation. |
During implantation
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Serious Adverse Device Effect (SADE) rate related to FLEXIGO delivery catheter or the slitter
Tidsramme: 72 hours after implantation
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Proportion of SADE related to the FLEXIGO delivery catheter or the slitter. |
72 hours after implantation
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Left Bundle Branch Area Pacing (LBBAP) implantation success rate per indication (cardiac pacing and CRT) and per ventricular pacing lead model
Tidsramme: During implantation
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- LBBAP implantation success rate with FLEXIGO delivery catheter (documented in cardiac pacing and CRT-D populations separately): 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, and documented in cardiac pacing and CRT-D populations separately): Proportion of lead successfully implanted at the interventricular septum with use of any material and fulfilling LBBAP success criteria according to the operator's decision. |
During implantation
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DARI01 - POLARIS
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