AXONE-Acute II: Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy
NCT ID: NCT04156412
Last Updated: 2020-06-29
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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UNKNOWN
NA
28 participants
INTERVENTIONAL
2020-01-02
2020-10-31
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
OTHER
NONE
Study Groups
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Implant test procedure
Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy
Implant test procedure
Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy
Interventions
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Implant test procedure
Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy
Eligibility Criteria
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Inclusion Criteria
* Patient presenting a CRT-P or CRT-D indication according to the latest ESC guidelines1.
* Primary implant of a CRT device (including upgrade from a single or dual-chamber pacemaker or ICD).
* Signed and dated informed consent.
Exclusion Criteria
* Allergy to contrast media used for imaging during cardiac catheterization.
* Severe Renal Failure (clearance of creatinine according to Modification of diet in renal disease formula (MDRD) \< 30ml/mn/m²).
* Previous failure of catheterization of the coronary sinus, or previous failure of left ventricular lead implantation.
* Already included in another clinical study involving intra-cardiac active implantable device, or participation to any other clinical trial in the last 2 weeks.
* Vulnerable patient such as person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision).
* Known pregnancy, breastfeeding or women in childbearing age without an adequate contraceptive method with a known failure rate \< 1%.-
18 Years
ALL
No
Sponsors
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MicroPort CRM
INDUSTRY
University Hospital, Rouen
OTHER
Responsible Party
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Principal Investigators
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Frédéric ANSELME, Pr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Rouen
Locations
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Bordeaux University Hospital
Bordeaux, , France
Clermont-Ferrand University Hospital
Clermont-Ferrand, , France
Lille University Hospital
Lille, , France
Rennes University Hospital
Rennes, , France
Rouen University Hospital
Rouen, , France
Hospital Universitari Germans Trias i Pujol
Badalona, , Spain
Hospital Universitario y Politécnico La Fe
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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Philippe RITTER, Pr
Role: primary
Frédéric Jean, MD
Role: primary
Didier KLUG, Pr
Role: primary
Christophe LECLERCQ, Pr
Role: primary
Frédéric ANSELME, Pr
Role: primary
Roger VILLUENDAS, MD
Role: primary
Joaquín OSCA, MD
Role: primary
Other Identifiers
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2019/127/HP
Identifier Type: -
Identifier Source: org_study_id
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