Assessment of the Axone micro quadripolar electrode for enhanced cardiac resynchronization therapy.A clinical study designed to obain the CE-mark.This new, quadripolar micro electrode allows for easier placement of the left ventricular lead,…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The study has 2 co-primary endpoints:
1. Co-primary safety endpoint, defined as a complication free ratio of the
Axone system 6 months post implant.
2. Co-primary performance endpoint, defined as successful left ventricular
stimulation 6 months post implant.
Secondary outcome
Secondary endpoint of the study is successful bi-zonal stimulation of the left
ventricle 6 months post implant.
Background summary
Assessment of the Axone micro quadripolar electrode for enhanced cardiac
resynchronization therapy.
A clinical study designed to obain the CE-mark.
This new, quadripolar micro electrode allows for easier placement of the left
ventricular lead, providing the physician with more options for successful
cardiac resynchronization therapy.
Study objective
Assessment of the Axone micro quadripolar electrode for enhanced cardiac
resynchronization therapy.
A clinical study designed to obain the CE-mark.
This new, quadripolar micro electrode allows for easier placement of the left
ventricular lead, providing the physician with more options for successful
cardiac resynchronization therapy.
Study design
Pre-market, interventional, prospective, longitudinal, single-arm, open label,
multicenter-study (European).
Intervention
Implant of the Axone quadripoloar left ventricular electrode.
Study burden and risks
There is a minor additional burden for the patient, in the sense that 1
additional follow-up visit is needed 1 month after implant.
Limited additional risk for the patient: a new left ventricular lead will be
implanted (manufactured by a company with more than 50 years experience in the
development of devices for cardiac stimulation).
Paasheuvelweg 25
Amsterdam 1105 BP
NL
Paasheuvelweg 25
Amsterdam 1105 BP
NL
Listed location countries
Age
Inclusion criteria
1. indication for a CRT device implant
2. de novo implant of a Platinium 4LV CRT-D device (or any newer model),
manufactured by Microport CRM
3. reviewed, signed and dated informed consent
Exclusion criteria
1. LV lead previous implant attempt
2. upgrade to a CRT-D from a previously implanted pacemaker or ICD, or CRT-D
replacement
3. known allergy to contrast media
4. tricuspid valve disease or replacement of tricuspid valve
5. severe renal failure
6. active myocarditis
7. stroke, myocardial infarction or cardiac revascularization within 40 days
prior to implant
8. previous heart transplant or on heart transplant list
9. life expectancy less than 1 year
10. included in another study which may confound the results in this study
11. pre-menopausal women, including pregnant and breastfeeding women
12. less than 18 years old or under guardianship
13. incapacitated, inability to understand the purpose of the study or to
adhere to the follow up protocol
14. diagnosis of drug addiction
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04463641 |
| CCMO | NL76054.075.20 |