Clinical Evaluation of the Physiological Diagnosis Function in the Paradym CRT device

Clinical Evaluation of the Physiological Diagnosis Function in the Paradym CRT device - CLEPSYDRA

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35038

Enrollment

Registered

2010-07-14

Start date

2010-09-02

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

exercise tolerance minute ventilation

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Contraindication for standard pacing. Contraindication for ICD therapy. Abdominal implantation site. Acute myocarditis.

Design outcomes

Primary

Measure	Time frame
Sensitivity of the PhD-inication in detecting HF events (device indicated) in relation to all HF-related clinical events. At least one of the following present: hospital admission, emergency room visit requiring intravenous drug treatment, invasive intervention, admission to intensive care, initiation of intravenous drug treatment without hospital admission, death. Mean number of false positives per year per patient. Success is defined as mean rate for study population statistically significantly less than two false positives per patient per year.	—

Measure

Time frame

Sensitivity of the PhD-inication in detecting HF events (device indicated) in relation to all HF-related clinical events. At least one of the following present: hospital admission, emergency room visit requiring intravenous drug treatment, invasive intervention, admission to intensive care, initiation of intravenous drug treatment without hospital admission, death. Mean number of false positives per year per patient. Success is defined as mean rate for study population statistically significantly less than two false positives per patient per year.

—

Secondary

Measure	Time frame
Sensitivity of Paradym PhD-indication in detecting HF events (device indicated HF event) in relation to all HF events related to oral treatment modification. Reported co-morbidity that was related to a PhD-indication in the device memory. Reported Adverse Events.	—

Countries

Netherlands

Outcome results