Compare Remote Patient Management and Standard Care in CRT-D and ICD-patients to Assess the Effect on Heart Failure (ConnectOptiVol)

Medtronic

Status: Completed

Conditions: Cardiac Desynchronization; Heart Failure; Ventricular Tachycardia

Treatments: Behavioral: Device triggered remote telephone contact because of Care Alert

Study type: Interventional

Funder types: Industry

Identifiers

NCT00730548

CEN_G_CA_7

Details and patient eligibility

About

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).

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

1

Experimental group

Description:

Remote Arm (OptiVol plus Connexus Telemetry plus CareLink plus Intervention Algorithm), Clinical Management Alerts ON

Treatment:

Behavioral: Device triggered remote telephone contact because of Care Alert

2

No Intervention group

Description:

No Care Alerts available, standard treatment of the patient