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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Bad Bevensen, Deutschland
- Herz- und Gefäßzentrum Bad Bevensen
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Annecy, Frankreich
- Centre Hospitalier Annecy Genevois
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Clermont-Ferrand, Frankreich
- CHU Clermont-Ferrand
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Montpellier, Frankreich
- Clinique du Millénaire
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Rouen, Frankreich
- CHU Rouen Hôpital Charles Nicolle
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Ferrara, Italien
- Arcispedale Sant'Anna - AO Univ.
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Novara, Italien
- Ospedale Maggiore della Carità - AO Univ.
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Taranto, Italien
- Ospedale SS Annunziata
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Treviso, Italien
- 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, Spanien
- Hospital Universitari de Girona Doctor Josep Trueta
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Granada, Spanien
- Hospital Universitario Virgen de las Nieves
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Las Palmas de Gran Canaria, Spanien
- Hospital Universitario de Gran Canaria Doctor Negrín
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Murcia, Spanien
- Hospital Clínico Universitario Virgen de la Arrixaca
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Valencia, Spanien
- Hospital Universitari i Politècnic La Fe
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: FLEXIGO-Einführungskatheter
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Use of FLEXIGO delivery catheter for implantation of ventricular pacing lead |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Absence of Unanticipated Serious Adverse Device Effect (USADE) related to FLEXIGO delivery catheter
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Implantation success rates
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- DARI01 - POLARIS
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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