Demonstrate that a risk score, based on non invasive long term ECG, can predict the absence of arrhythmias requiring ICD intervention or the absence of sudden death, with a >90% certainty (NPV) in patients with a reduced LVEF currently qualifying…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The absence of arrhythmias requiring ICD intervention or the absence of sudden
death
Secondary outcome
Demonstrate that heart failure hospital admission / cardiac death can be
predicted by non invasive methods in patients with a reduced LVEF currently
qualifying for primary ICD implantation.
Show that slow VT as recorded by the ICD is associated with heart failure
development/ cardiac death
Show that safeR is not associated with ventricular pacing during follow-up
Prospectively demonstrate that very low LVEF values (30% and less) are
predictive for future ICD intervention in patients currently qualifying for
primary ICD implantation with contemporary infarction and heart failure
therapy.
Background summary
Today patients are selected for preventive ICD implantation (also called
primary indication) when the risk of sudden death is considered excessive as
compared to not receiving an ICD. It is not always certain if the patient
indeed benefits from this ICD implantation. It is very well possible that a
patient who received an ICD would eventually not have needed this implantation
(over many years he/she would not has arrhythmias requiring a therapy delivery
from the ICD). However, ICD in primary prevention saves lifes. Physicians and
insurance companies are dealing in different ways with the European guidelines
for a preventive ICD implantation because of various medical and economic
reasons.
Study objective
Demonstrate that a risk score, based on non invasive long term ECG, can predict
the absence of arrhythmias requiring ICD intervention or the absence of sudden
death, with a >90% certainty (NPV) in patients with a reduced LVEF currently
qualifying for primary ICD implantation.
Study design
A non-randomized prospective clinical observational multi-centric trial.
Intervention
Patients identified as per the guidelines will receive an ICD.
Study burden and risks
The benefits of this trial are that the patient will receive extensive
attention after ICD implantation. Furthermore, participation will contribute to
the improvement of patient care via the development of a predictive score that
could improve the selection of future patient who will benefit of ICD
treatment. This score could also avoid unnecessary ICD implantation in certain
patients.
There are no foreseeable anticipated increased risks associated with the use of
Holter recorders. The Holter recorder is a non-invasive tool and is
commercially available.
There are no foreseeable anticipated increased risks associated with
implantation of the PARADYM ICD (CE Mark approved) compared to other
commercially available ICD devices.
Furthermore, participation in this study does not involve any additional risks
for the patient, as he/she is already scheduled for an ICD implantation.
In case the patient is a woman of childbearing potential she has to use
anticonception for the duration of the study. Breastfeeding is prohibited.
Paasheuvel 1, PO Box 12060
1100 AB Amsterdam
NL
Paasheuvel 1, PO Box 12060
1100 AB Amsterdam
NL
Listed location countries
Age
Inclusion criteria
- Criteria for prophylactic ICD according to guidelines in patients with reduced LVEF
- Written informed consent
- Scheduled for implant of a PARADYM 8550 or PARADYM 9550
Exclusion criteria
1. Under the age of 18 years old
2. Presence of a permanent pacemaker or previous ICD
3. Permanent AF
4. NYHA IV
5. Within 8 weeks of infarction or within 3 months of coronary revascularization
6. Patient requiring permanent amiodarone or antiarrhythmic drugs.
7. Specific familial or genetic based arrhythmias.
8. ARVC, HCM, or severe valvular disease
9. CRT indication (European guidelines)
10. Renal hemodialysis
11. Recipient of cardiac transplant
12. Pregnancy
13. Advanced malignancy
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 |
|---|---|
| CCMO | NL33039.100.10 |