The objective of the study is demonstrate the safety and efficacy of the subcutaneous defibrillation system.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints are afety and efficacy. Safety is defined a
complication-free rate of 79% at 6 months follow-up.
Efficacy will be assessed by measuring the conversion efficacy rate of
ventricular fibrillation, which has to exceed 88%.
Secondary outcome
not applicable
Background summary
The implantable cardioverter-defibrillator (ICD) is an established and
effective therapy to prevent arrhythmic mortality from life-threatening
ventricular arrhythmias. Conventional ICDs use at least one lead which is
placed in or on the heart, predominantly the right ventricular lead.
Both the implantation procedure and the lead itself are associated with
complications, like infection, lead dysfunction or dislocation. The
subcutaneous defibrillation system has been developed to prevent these
complications associated with the implantation procedure or the transvenous
lead. The subcutaneous system uses a lead which is placed subcutaneous by
anatomical landmarks.
Study objective
The objective of the study is demonstrate the safety and efficacy of the
subcutaneous defibrillation system.
Study design
Prospective cohort study in patients with an indication for ICD therapy. The
intervention is the implantation of the subcutaneous defibrillation system, and
subsequently the study is observational in nature.
Intervention
The intervention is the implantation of the subcutaneous defibrillation system
according to the standard protocol at the Erasmus MC.
Study burden and risks
No additional burden and risks are present for patients participating in the
study. The number and frequency of visits is similar to the standard procedure
of scheduled visits to the outpatient clinic for ICD patients.
905 Calle Amanecer, Suite 300
San Clemente, CA 92673
US
905 Calle Amanecer, Suite 300
San Clemente, CA 92673
US
Listed location countries
Age
Inclusion criteria
Patients with a Class I / Class II indication for ICD therapy according to the International guidelines for ICD therapy
Exclusion criteria
Patients with symptomatic bradycardia
Patients with ventricular tachycardia which can be reliably terminated by antitachycardia pacing therapy
Patients with renal failure
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 | NCT01064076 |
| CCMO | NL31901.078.10 |