Safety and electrical performances evaluation of Navigo left ventricular leads with an IS4 connector, which are used at the implant of a cardiac resynchronisation system.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Resistance, stimulation threshold, sensing values of the Navigo lead at
pre-discharge, 2, 6, 12, 18 and 24 months.
Safety of the lead at 6, 12, 18 and 24 months.
Document Serious Adverse Events.
Document handling performance.
Document percentage of successful implants.
Document number of patients with multi-point pacing.
Document number of patients with a stimulation threshold of the Navigo lead of
less than 2.5 Volts x 0.5 milliseconds for at least 2 different vectors;
without phrenic nerve stimulation.
Secondary outcome
Not applicable.
Background summary
Safety and electrical performances evaluation of Navigo left ventricular leads
with an IS4 connector, which are used at the implant of a cardiac
resynchronisation system.
Study objective
Safety and electrical performances evaluation of Navigo left ventricular leads
with an IS4 connector, which are used at the implant of a cardiac
resynchronisation system.
Study design
Pre-market, prospective, single-arm, international, multicentre, observational
study with e limited number of additional electrical measurements of the
defibrillator at the 2 to 3-month follow-up visit.
Study burden and risks
Very limited additional burden for the patient at the 2-month follow-up visit;
this visit will take app. 15 minutes longer.
Limited risk: a new type of left ventricular lead is being used, from a
manufacturer with more than 20 years experience - and excellent results (ever
since the introduction of this therapy).
Westerdoksdijk 423
Amsterdam 1013 BX
NL
Westerdoksdijk 423
Amsterdam 1013 BX
NL
Listed location countries
Age
Inclusion criteria
indication for CRT implant, upgrade from ICD to CRT
signed and dated informed consent
Exclusion criteria
intolerace of dosage dexamethasone higher than 300 picograms
transvenous LV cardia vein access impossible
Design
Recruitment
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 |
|---|---|
| CCMO | NL61815.075.17 |