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 Failure; Cardiac Desynchronization; Ventricular Tachycardia
• Interventions: Behavioral: Device triggered remote telephone contact because of Care Alert

• Registration Number: NCT00730548
• Lead Sponsor: Medtronic Bakken Research Center

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

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-06-19
• Study First Submitted QC: 2008-08-04
• Study First Posted: 2008-08-08
• Primary Completion: 2011-04
• Study Completion: 2013-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-02-15

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

Arm && Interventions

Group	Intervention	Description
1	Device triggered remote telephone contact because of Care Alert	Remote Arm (OptiVol plus Connexus Telemetry plus CareLink plus Intervention Algorithm), Clinical Management Alerts ON

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

Trial Locations

Locations (1)

University Hospital of Goettingen; 🇩🇪 Goettingen, Germany