Safety and performance of Invicta ventricular DF4 leads with active fixation.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Early safety and performance endpoint:
• Freedom from Unanticipated Serious Adverse Device Effect (USADE) from RV
lead, from attempt to implant to 1M. The endpoint will consider any serious
adverse device effect which by its nature, incidence, severity or outcome was
not identified in the risk analysis report.
The anticipated patients* free-rate is 100%, against a priori performance goal
of 95%.
• Summarize RV pacing threshold amplitude (V), RV pacing impedance (Ohm),
endocardial R wave amplitude (mV), defibrillation coil impedance (Ohm) at 1
month.
The result of this analysis will not determine the success or failure of the
study.
This endpoint has been selected in order to grow a body of evidence (that
starts with few pts at 1M, and ends with a large population at 2 years): the
assessment of this analysis will be done by the Data Safety Monitoring Board
(DSMB).
The study will have 2 co-primary endpoints, assessed independently on the
subjects enrolled in Phase I:
• INVICTA lead safety at 3 months: freedom from RV lead-related complications
that occurred up to 90 days from first attempt to implant the INVICTA lead. A
complication is defined as any serious adverse event related to the INVICTA
lead (SADE) that resulted in patient death or required an additional invasive
intervention. Lead-related complications may occur during or after the implant
procedure. The anticipated complication-free rate is 0.97, against a priori
performance goal of 0.90.
• INVICTA lead performance at 3 months: RV pacing threshold at 3 months from
successful implant. The anticipated pacing threshold value is 1.0±0.5 V at 0.5
ms, against a priori performance goal of <1.25 V.
Secondary outcome
1. INVICTA pacing threshold amplitude (V), RV pacing impedance (Ohm),
endocardial R wave amplitude (mV), defibrillation coil impedance(Ohm) at
Implant, pre-hospital discharge, 1 month, 3, 6, 12, 18 and 24 months after
implant.
2. Efficacy of INVICTA leads to terminate ventricular tachycardia (VT) and/or
ventricular fibrillation (VF) by endocardial shock therapies, when a
defibrillation test is performed (at physician discretion) or a spontaneous
ventricular arrhythmia occurs.
3. Acute INVICTA lead complications (<=30 days post-implant).
4. Chronic INVICTA lead complications (>30 days post-implant).
5. Daily INVICTA autothreshold values (V) from implant to M1 visit (applicable
if implanted with an ICD model with auto-threshold feature enabled).
6. INVICTA lead handling assessment.
7. INVICTA lead implant success rate.
8. SAE's up to 24 months post implantation
Tertiary endpoints:
1. Acute complication rates as a function of the lead position (apical vs
septal, <= 30 days post-implantation).
2. Chronic complication rates as a function of the lead position (apical vs
septal, > 30 days post-implantation).
Electrical performances as a function of the lead position (apical vs septal),
up to 24 months post-implantation
Background summary
Safety and performance of Invicta ventricular DF4 leads with active fixation.
Study objective
Safety and performance of Invicta ventricular DF4 leads with active fixation.
Study design
Pre-market, prospective, logitudinal, single arm international (European)
study.
Study burden and risks
There is no addtional burden for the patient.
Nor is there an expected benefit for the patient, other than an easier implant
procedure and an improved reliability od the electrical connections.
Paasheuvelweg 25
Amsterdam 1105 BP
NL
Paasheuvelweg 25
Amsterdam 1105 BP
NL
Listed location countries
Age
Inclusion criteria
1. Indication for an ICD or CRT-D implant, according to ESC guidelines.
2. Scheduled for a de novo implant of an ICD (VR, DR) or CRT-D, manufactured by
Microport CRM, equipped with a DF4-connector.
3. Dated and signed Informed Consent.
Exclusion criteria
1. Tricuspid valvular disease, or tricuspid valve replacement of any kind.
2. Transient tachy-arhythmias due to reversible causes.
3. Contra-indication to a maximum single dose of 330 ug dexamethasone sodium
phosphate (DSP).
4. Active myocarditis.
5.Previous implant of a pacemaker, ICD or CRT-D device and leads.
6. Enrolled in another study that may confound the results of the Apollo study.
7. Inability to understand the purpose of the study.
8. Under the age of 18.
9. Pre-menopausal women.
10. Drug addiction or drug abuse.
11. Life expectancy less than 1 year.
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 | EUDRA-CT 2020-AOO963-36 |
| CCMO | NL73839.075.20 |