Clinical Evaluation of the SonR atrial lead in the Paradym RF device

Clinical Evaluation of the SonR atrial lead in the Paradym RF device - Klinische evaluatie van de SonR atriale electrode in de Paradym RF ICD

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON34489

Enrollment

Registered

2010-11-23

Start date

2010-12-14

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart failure ventricular dysssynchrony

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Indication for a biventricular defibrillator and chronic heart failure.

Exclusion criteria

Exclusion criteria: Contra-indication for standard pacing. Contra-indication for ICD therapy. Acute myocarditis.

Design outcomes

Primary

Measure	Time frame
Atrial lead complication rate superior to 90% after 3 months. Comparison of automatic and manual right ventricular stimulation threshold after 1 month.	—

Secondary

Measure	Time frame
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.	—

Countries

Netherlands

Outcome results