Demonstrate a SonR atrial lead complication free rate superior to 90% after 3 months.Demonstrate the right ventricular auto threshold performance by comparing manual and automatic measurements performed at 1 month follow-up visit.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Atrial lead complication rate superior to 90% after 3 months.
Comparison of automatic and manual right ventricular stimulation threshold
after 1 month.
Secondary outcome
Report Serious Adverse Events and Adverse Events.
Report electrical functionality of the ICD.
Report electrical functionality of the SonR atrial lead.
Report hemodynamic performance measurements from the SonR atrial lead.
Background summary
Optimisation of AV and VV delays improves the hemdynamic functionality, and
positively influences left ventricular remodeling. This study assesses the
contribution of the use of the SonR atrial lead together with the Paradym RF
device.
Study objective
Demonstrate a SonR atrial lead complication free rate superior to 90% after 3
months.
Demonstrate the right ventricular auto threshold performance by comparing
manual and automatic measurements performed at 1 month follow-up visit.
Study design
Prospective, multi-centre, non-randomized, pivotal trial.
Study burden and risks
No additional risk.
Paasheuvelweg 1
1100 AB Amsterdam
NL
Paasheuvelweg 1
1100 AB Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Indication for a biventricular defibrillator and chronic heart failure.
Exclusion criteria
Contra-indication for standard pacing.
Contra-indication for ICD therapy.
Acute myocarditis.
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 |
|---|---|
| CCMO | NL33151.075.10 |