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Clinical Trials in Germany / NCT04463641
Active, not recruiting Not applicable

Assessment of the Axone Micro Quadripolar Lead for Enhanced Cardiac Resynchronization Therapy

NCT04463641 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2020-12-03
Last updated
2024-01-05

Condition(s) studied

Heart FailureCardiac Resynchronization Therapy

Investigational drug(s) / intervention(s)

Implantation of the Axone 4LV Lead

Implantation of the Axone 4LV Lead: Implantation of the Axone 4LV Lead

Study summary

The primary objective of this study is to assess the chronic safety and performance of the Axone left ventricular (LV) micro-lead.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Indication for cardiac resynchronization therapy-defibrillator (CRT-D) device implant according to the latest ESC (European Society of Cardiology) guidelines * De-novo implant of a Platinium 4LV CRT-D device (or any newer 4LV CRT-D model manufactured by MicroPort CRM) * Reviewed, signed and dated informed consent form Exclusion Criteria: * LV lead previous implant attempt * Upgrade to CRT from a previously implanted pacemaker or implantable cardioverter-defibrillator (ICD), or CRT device replacement * Known allergy to contrast media used for imaging during cardiac catheterization * Tricuspid valvular disease or any type of tricuspid replacement heart valve (mechanical or tissue) * Severe renal failure (creatinine clearance according to the Modification of Diet in Renal Disease (MDRD) formula \< 30ml/min/m²) * Active myocarditis * Stroke, myocardial infarction or cardiac revascularization within 40 days prior to implant * Previous heart transplant or currently on heart transplant list * Life expectancy less than 1 year * Already included in another clinical study that could confound the results of this study * Pre-menopausal women / women in childbearing age, including pregnant and breastfeeding women * Less than 18 years old or under guardianship * Incapacitated subject, inability to understand the purpose of the study, or to meet follow-up visits at the implanting site as defined in the protocol * Diagnosis of drug addiction (substance use disorder)

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
Kepler Universitätsklinikum Linz Austria
CH Annecy Genevois Annecy France
CHRU Hopital Trousseau Chambray-lès-Tours France
CHU de Clermont-Ferrand Clermont-Ferrand France
CHU Grenoble Grenoble France
CHRU de Lille - Hôpital Cardiologique Lille France
CHU Pontchaillou Rennes France
CHU de Rouen Rouen France
CHU Toulouse Toulouse France
Universitätsklinikum Hamburg Eppendorf Hamburg Germany
Universitätsklinikum Heidelberg Heidelberg Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel Kiel Germany
ASST Spedali Civili di Brescia Brescia Italy
Ospedale Pellegrini Naples Italy
Ospedale Policlinico Federico II Naples Italy
Isala Klinieken Zwolle Netherlands
Centro Hospitalar Universitário Lisboa Norte - Hospital de Santa Maria Lisbon Portugal
Centro Hospitalar Universitário do Porto Porto Portugal
Hospital Universitario General de Alicante Alicante Spain
Hospital Universitario La Fe Valencia Spain
Hospital Álvaro Cunqueiro Vigo Spain

More MicroPort CRM trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04463641 on ClinicalTrials.gov ↗ ← All trials in Germany