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

Clinical Evaluation to Assess the Effect of the Combination of a Pre-Defined Management Pathway to Reduce Fluid Overload in Cardiac Decompensation With Carelink Remote Management, Connexus Remote Telemetry and the OptiVol Early Warning System on Health Care Utilization

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00730548

Acronym

ConnectOptiVol

Enrollment

180

Registered

2008-08-08

Start date

2007-11-30

Completion date

2013-08-31

Last updated

2025-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Desynchronization, Heart Failure, Ventricular Tachycardia

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).

Interventions

BEHAVIORALDevice triggered remote telephone contact because of Care Alert

Care Alerts on, physician will be notified in case of an Care Alert. Depending on the outcome of the telephone contact drug adjustment and / or further interventions can be prescribed

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Time to first hospitalization due to worsened heart failure	15 months

Secondary

Measure	Time frame
Time from device detected onset of arrhythmias, cardiovascular disease progression and system issues to clinical decision making	15 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026