Safety and electrical performances of Navigo leads equipped with IS4 connector

Safety and electrical performances of Navigo leads equipped with IS4 connector - Navigator

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47542

Enrollment

Registered

2018-08-30

Start date

2018-02-11

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

heart failure pump failure

Interventions

cardiac resynchronisation

IS4 connector

LV lead

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: indication for CRT implant, upgrade from ICD to CRT signed and dated informed consent

Exclusion criteria

Exclusion criteria: intolerace of dosage dexamethasone higher than 300 picograms transvenous LV cardia vein access impossible

Design outcomes

Primary

Measure	Time frame
Resistance, stimulation threshold, sensing values of the Navigo lead at pre-discharge, 2, 6, 12, 18 and 24 months. Safety of the lead at 6, 12, 18 and 24 months. Document Serious Adverse Events. Document handling performance. Document percentage of successful implants. Document number of patients with multi-point pacing. Document number of patients with a stimulation threshold of the Navigo lead of less than 2.5 Volts x 0.5 milliseconds for at least 2 different vectors; without phrenic nerve stimulation.	—

Measure

Time frame

Resistance, stimulation threshold, sensing values of the Navigo lead at pre-discharge, 2, 6, 12, 18 and 24 months. Safety of the lead at 6, 12, 18 and 24 months. Document Serious Adverse Events. Document handling performance. Document percentage of successful implants. Document number of patients with multi-point pacing. Document number of patients with a stimulation threshold of the Navigo lead of less than 2.5 Volts x 0.5 milliseconds for at least 2 different vectors; without phrenic nerve stimulation.

—

Secondary

Measure	Time frame
Not applicable.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)