Compare Remote Patient Management and Standard Care in CRT-D and ICD-patients to Assess the Effect on Heart Failure
Not Applicable
Completed
- Conditions
- Heart FailureCardiac DesynchronizationVentricular Tachycardia
- Registration Number
- NCT00730548
- Lead Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Brief Summary
This pilot study is to prospectively evaluate the benefit of clinicians being able to access ICD device information in a timelier manner and treat fluid overload with a pre-defined pattern using the Medtronic OptiVol, Medtronic CareAlerts and Medtronic CareLink in Conexus-enabled devices (remote arm) as compared to the same devices without Medtronic OptiVol, Medtronic CareAlerts and Medtronic CareLink available to the treating physician (standard arm).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
Inclusion Criteria
- Implantation of a market-approved Medtronic Connexus CRT-D- or DR-ICD-device
- Patient consents to study
- Ability to replace follow-ups with CareLink follow-ups
- Ability to attend all follow-ups at study center
Exclusion Criteria
- Permanent AF
- Less than 18 years of age
- Life expectancy less than 15 months
- Participation in another clinical study
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time to first hospitalization due to worsened heart failure 15 months
- Secondary Outcome Measures
Name Time Method Time from device detected onset of arrhythmias, cardiovascular disease progression and system issues to clinical decision making 15 months
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie fluid overload in CRT-D and ICD patients with heart failure?
How does remote patient management with OptiVol compare to standard care in reducing hospitalizations for cardiac decompensation?
Which biomarkers predict response to remote monitoring in patients with ventricular tachycardia and heart failure?
What adverse events are associated with CareLink remote management in CRT-D device therapy?
Are there alternative remote monitoring systems to Medtronic Conexus for managing fluid overload in heart failure patients?
Trial Locations
- Locations (1)
University Hospital of Goettingen
🇩🇪Goettingen, Germany
University Hospital of Goettingen🇩🇪Goettingen, Germany