Safety and electrical performance evaluation of Invicta leads moodels equipped with DF-4-connector.Clinical study to support the submission for acquiring the CE-mark.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Lead safety after 3 months: absence of any lead-related complications.
Electrical performance after 3 months: stable stimulation thresholds in the
right ventricle (expected values: 1 Volt +/- 0,5 Volt and a pulse duration of
0,5 ms.
Secondary outcome
Document electrical performance of the right ventricular lead: sensing
thershold in mV, impedance in Ohm, stimulation threshold in Volt x ms.
Document good detection of VT and VF, as well as adequate delivery of therapy
(anti-tachy pacing or defibrillation shock).
Safety of the right ventricular lead.
Handling assessment of the right ventricular lead.
Successful implant percentage of the right ventricular lead.
Background summary
Safety and electrical performance evaluation of Invicta leads moodels equipped
with DF-4-connector.
Clinical study to support the submission for acquiring the CE-mark.
Study objective
Safety and electrical performance evaluation of Invicta leads moodels equipped
with DF-4-connector.
Clinical study to support the submission for acquiring the CE-mark.
Study design
Pre-market, prospective, longitudinal single-arm, international (European),
multi-centre.
Study burden and risks
No additional burden for the patient.
No expected additional benefit for the patient, other than an easier implant
procedure and electrical connection trustworthiness.
Hoogoorddreef 5
Amsterdam 1101 AT
NL
Hoogoorddreef 5
Amsterdam 1101 AT
NL
Listed location countries
Age
Inclusion criteria
Indication for ICD or CRT/D implant (defibrillator) according to ESC guidelines.
Exclusion criteria
Tricuspid valvular disease or mechanical heart valve.
Active myocarditis.
Pregnant, or not taking/using contraceptives when of a fertile age.
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 |
|---|---|
| Other | CIV-PT-025366 |
| CCMO | NL67315.075.18 |