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.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Bad Bevensen, 독일
- Herz- und Gefäßzentrum Bad Bevensen
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Girona, 스페인
- Hospital Universitari de Girona Doctor Josep Trueta
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Granada, 스페인
- Hospital Universitario Virgen de las Nieves
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Las Palmas de Gran Canaria, 스페인
- Hospital Universitario de Gran Canaria Doctor Negrín
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Murcia, 스페인
- Hospital Clínico Universitario Virgen de la Arrixaca
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Valencia, 스페인
- Hospital Universitari i Politècnic La Fe
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Ferrara, 이탈리아
- Arcispedale Sant'Anna - AO Univ.
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Novara, 이탈리아
- Ospedale Maggiore della Carità - AO Univ.
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Taranto, 이탈리아
- Ospedale SS Annunziata
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Treviso, 이탈리아
- Ospedale Ca' Foncello
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Coimbra, 포르투갈
- ULS de Coimbra
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Lisbon, 포르투갈
- ULS Santa Maria
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Lisbon, 포르투갈
- ULS Lisboa Ocidental - Hospital de Santa Cruz
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Annecy, 프랑스
- Centre Hospitalier Annecy Genevois
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Clermont-Ferrand, 프랑스
- CHU Clermont-Ferrand
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Montpellier, 프랑스
- Clinique du Millénaire
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Rouen, 프랑스
- CHU Rouen Hôpital Charles Nicolle
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: FLEXIGO 전달 카테터
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Use of FLEXIGO delivery catheter for implantation of ventricular pacing lead |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Absence of Unanticipated Serious Adverse Device Effect (USADE) related to FLEXIGO delivery catheter
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Implantation success rates
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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