Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-29 @ 10:20 AM
Study NCT ID:
NCT06453850
Status:
RECRUITING
Last Update Posted:
2025-03-06
First Post:
2024-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Performance Evaluation of a New Catheter Range for Lead Implantation At Interventricular Septum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001919', 'term': 'Bradycardia'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 216}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2024-05-29', 'studyFirstSubmitQcDate': '2024-06-05', 'lastUpdatePostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absence of Unanticipated Serious Adverse Device Effect (USADE) related to FLEXIGO delivery catheter', 'timeFrame': '72 hours after implantation', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Implantation success rates', 'timeFrame': 'During implantation', 'description': "\\- Implantation success rate with FLEXIGO delivery catheter: Proportion of lead successfully implanted at the interventricular septum with use of the FLEXIGO delivery catheter.\n\n\\- 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.\n\n\\- LBBAP implantation success rate (overall): Proportion of lead successfully implanted at the interventricular septum with use of any material and fulfilling LBBAP success criteria."}, {'measure': 'Implantation time', 'timeFrame': 'During implantation', 'description': 'Total procedural time and total fluoroscopic time documented per type of cardiac device implanted and per model of catheter used.'}, {'measure': 'Implantation usability', 'timeFrame': 'During implantation', 'description': 'Implantation usability of the FLEXIGO delivery catheter documented through handling scores based on a specific questionnaire addressed to the operator after implantation.'}, {'measure': 'Serious Adverse Device Effect (SADE) rate related to FLEXIGO delivery catheter or the slitter', 'timeFrame': '72 hours after implantation', 'description': 'Proportion of SADE related to the FLEXIGO delivery catheter or the slitter.'}, {'measure': 'Left Bundle Branch Area Pacing (LBBAP) implantation success rate per indication (cardiac pacing and CRT) and per ventricular pacing lead model', 'timeFrame': 'During implantation', 'description': "\\- 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.\n\n\\- 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."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bradycardia', 'Cardiac Resynchronization Therapy', 'Left Bundle Branch Area Pacing']}, 'descriptionModule': {'briefSummary': 'The purpose of the clinical investigation is to evaluate the safety of the FLEXIGO delivery catheter for transvenous pacing lead implantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria (phase I):\n\n* Patient indicated for cardiac pacing according to the most recent guidelines from the European Society of Cardiology (ESC)\n* Patient planned for a de novo implantation of any Single Chamber (SR) or Dual Chamber (DR) CE marked pacemaker\n* Patient planned for a catheter-guided implantation in the interventricular septum area\n* Patient planned for the implantation of any CE marked ventricular pacing lead compatible with the FLEXIGO delivery catheter\n* Patient reviewed, signed and dated the Informed Consent Form (ICF)\n\nInclusion criteria (phase II):\n\n* Patient indicated for cardiac pacing or CRT according to the most recent guidelines from the ESC\n* Patient planned for a de novo implantation of any SR or DR CE marked pacemaker, or any CE marked CRT-D\n* Patient planned for a catheter-guided implantation in the interventricular septum area\n* Patient planned for the implantation of any CE marked ventricular pacing lead compatible with the FLEXIGO delivery catheter\n* Patient reviewed, signed and dated the ICF\n\nExclusion criteria (phase I):\n\n* Patient planned for a device upgrade, or a device or a lead replacement\n* Patient with a congenital heart disease\n* Patient with significant hypertrophic cardiomyopathy, cardiac amyloidosis or obstructive hypertrophic cardiomyopathy\n* Patient with a Left Ventricular Ejection Fraction (LVEF) ≤ 35%\n* Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device)\n* 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)\n* Minor age patient (i.e. under 18 years of age)\n* Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation\n* Non-menopausal women\n\nExclusion criteria (phase II):\n\n* Patient planned for a device upgrade, or a device or a lead replacement\n* Patient with a congenital heart disease\n* Patient with significant hypertrophic cardiomyopathy, cardiac amyloidosis or obstructive hypertrophic cardiomyopathy\n* Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device)\n* 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)\n* Minor age patient (i.e. under 18 years of age)\n* Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation\n* Non-menopausal women'}, 'identificationModule': {'nctId': 'NCT06453850', 'acronym': 'POLARIS', 'briefTitle': 'Safety and Performance Evaluation of a New Catheter Range for Lead Implantation At Interventricular Septum', 'organization': {'class': 'INDUSTRY', 'fullName': 'MicroPort CRM'}, 'officialTitle': 'Safety and Performance Evaluation of a New Catheter Range for Lead Implantation At Interventricular Septum', 'orgStudyIdInfo': {'id': 'DARI01 - POLARIS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FLEXIGO delivery catheter', 'interventionNames': ['Device: Use of FLEXIGO delivery catheter']}], 'interventions': [{'name': 'Use of FLEXIGO delivery catheter', 'type': 'DEVICE', 'description': 'Use of FLEXIGO delivery catheter for implantation of ventricular pacing lead', 'armGroupLabels': ['FLEXIGO delivery catheter']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Coimbra', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'João Ferreira', 'role': 'CONTACT', 'email': 'joaoaferreira29@gmail.com'}], 'facility': 'ULS de Coimbra', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'city': 'Granada', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Manuel Molina', 'role': 'CONTACT', 'email': 'manuel.molina.lerma@gmail.com'}], 'facility': 'Hospital Universitario Virgen de las Nieves', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Óscar Cano', 'role': 'CONTACT', 'email': 'oscape13@hotmail.com'}], 'facility': 'Hospital Universitari i Politècnic La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'centralContacts': [{'name': 'Antoine Guihard', 'role': 'CONTACT', 'email': 'antoine.guihard@crm.microport.com', 'phone': '+33 1 46 01 33 20'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MicroPort CRM', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}