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

Medtronic Cardiac Rhythm and Heart Failure180 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

180

Conditions

Heart Failure Ventricular Tachycardia Cardiac Desynchronization

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Time to first hospitalization due to worsened heart failure

Time frame: 15 months

Secondary Outcomes

Time from device detected onset of arrhythmias, cardiovascular disease progression and system issues to clinical decision making