AXONE-Acute-2: AXONE-Acute II: Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy
Study Details
Study Description
Brief Summary
Pilot study to evaluate the performance of a lead below 2 French with specific distal shape to deliver efficient LV pacing
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Implant test procedure Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy |
Device: Implant test procedure
Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy
|
Outcome Measures
Primary Outcome Measures
- LV Bi-zone pacing success rate [30 min]
Percent of patients where the placement of the AXONE lead provides two distant LV pacing vectors matching: Pacing Threshold ≤ 3.5V/0.5ms.
- LV pacing success rate [30 min]
Percent of patients where the placement of the AXONE lead allows at least one LV pacing vectors matching: Pacing Threshold ≤ 3.5V/0.5ms.
Secondary Outcome Measures
- Device or Implant testing procedure-related Adverse Events [1 month post intervention]
- Electrical performance (1) [30 min]
LV pacing threshold (Volt)
- Electrical performance (2) [30 min]
LV pacing impedance (Ohm)
- AXONE Implant Efficiency (1) [30 min]
procedure time for successful placement
- AXONE Implant Efficiency (2) [30 min]
fluoroscopic time
- AXONE Implant Efficiency (3) [30 min]
radiation dose
- AXONE Implant Efficiency (4) [30 min]
handling assessment.
- LV multipoint pacing success [30 min]
the placement of the AXONE provides two pacing vectors matching
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female patient aged ≥18 years old.
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Patient presenting a CRT-P or CRT-D indication according to the latest ESC guidelines1.
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Primary implant of a CRT device (including upgrade from a single or dual-chamber pacemaker or ICD).
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Signed and dated informed consent.
Exclusion Criteria:
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Class IV of NYHA (ambulatory or not).
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Allergy to contrast media used for imaging during cardiac catheterization.
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Severe Renal Failure (clearance of creatinine according to Modification of diet in renal disease formula (MDRD) < 30ml/mn/m²).
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Previous failure of catheterization of the coronary sinus, or previous failure of left ventricular lead implantation.
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Already included in another clinical study involving intra-cardiac active implantable device, or participation to any other clinical trial in the last 2 weeks.
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Vulnerable patient such as person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision).
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Known pregnancy, breastfeeding or women in childbearing age without an adequate contraceptive method with a known failure rate < 1%.-
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bordeaux University Hospital | Bordeaux | France | ||
| 2 | Clermont-Ferrand University Hospital | Clermont-Ferrand | France | ||
| 3 | Lille University Hospital | Lille | France | ||
| 4 | Rennes University Hospital | Rennes | France | ||
| 5 | Rouen University Hospital | Rouen | France | ||
| 6 | Hospital Universitari Germans Trias i Pujol | Badalona | Spain | ||
| 7 | Hospital Universitario y Politécnico La Fe | Valencia | Spain |
Sponsors and Collaborators
- University Hospital, Rouen
- MicroPort CRM
Investigators
- Principal Investigator: Frédéric ANSELME, Pr, Rouen University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019/127/HP