See section 3.2 on protocol page 24The purpose of the clinical study is to demonstrate the safety and efficacy of the EV ICD System: a complete single-chamber extravascular ICD system with the lead implanted substernally
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
See section 4 on protocol page 24
Primary Safety Objective: Demonstrate the freedom from major complications
related to the EV ICD System and/or procedure at 6 months post-implant exceeds
79% Objective Performance Criterion (OPC).
Primary Efficacy Objective: Demonstrate the EV ICD defibrillation testing
success rate at implant is greater than 88% OPC.
Secondary outcome
See section 4 on protocol page 24
• Characterize appropriate and inappropriate shocks
• Characterize electrical performance (pacing capture thresholds, pacing
impedance, sensing amplitudes) over time
• Characterize extracardiac pacing sensation
• Characterize asystole pacing
• Summarize ATP performance with spontaneous arrhythmias
• Summarize adverse events
• Characterize the EV ICD defibrillation testing success rate at 6 months
post-implant.
Background summary
See section 3.1 on protocol page 22
Today, implantable cardioverter defibrillator (ICD) therapy is the treatment of
choice for patients who are at risk for sudden cardiac death due to
life-threatening ventricular arrhythmias
However, these systems have limitations.
As a result, there is demand for novel ICD systems that circumvent the
potential disadvantages of transvenous ICD systems by preserving the heart and
vasculature.
Study objective
See section 3.2 on protocol page 24
The purpose of the clinical study is to demonstrate the safety and efficacy of
the EV ICD System: a complete single-chamber extravascular ICD system with the
lead implanted substernally
Study design
See section 5 on protocol page 26
The EV ICD Pivotal Study is a prospective, multi-center, single-arm,
non-randomized, pre-market clinical study.
Enrollment will include up to 400 subjects at up to 60 sites worldwide.
Intervention
Implantation of EV ICD system
Study burden and risks
See section 9 on protocol page 77
The unique risks introduced by the EV ICD System include: unique harms
associated with procedural complications, unique harms associated with
defibrillating from a substernal lead position, unique harms from chronic lead
implant in the substernal space, and the general risk that an EV ICD System has
not yet been chronically implanted in humans for greater than 12 months.
Endepolsdomein 5
Maastricht 6229 GW
NL
Endepolsdomein 5
Maastricht 6229 GW
NL
Listed location countries
Age
Inclusion criteria
Patient has a Class I or IIa indication for implantation of an ICD according to
the Guidelines.
Patient is at least 18 years of age.
Exclusion criteria
Patient is unwilling or unable to personally provide Informed Consent.
Patient has indications for bradycardia pacing x or Cardiac Resynchronization
Therapy (CRT).
Patients with an existing pacemaker, ICD, or CRT device or leads.
Patients with medical interventions or specific medical conditions as specified
in CIP.
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 | NCT04060680 |
| CCMO | NL71101.100.19 |