Skip to main content
OpenTrials
Completed

NCT Number: NCT00730548

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiac Desynchronization Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular Ventricular Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Goettingen

Göttingen, 37099, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Device triggered remote telephone contact because of Care Alert

Behavioral

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

Other names: OptiVol, CareLink, Medtronic Concerto, Medtronic Consulta, Medtronic Secura, Medtronic Virtuoso

Primary outcomes

  1. Time to first hospitalization due to worsened heart failure

    Time frame: 15 months

Secondary outcomes

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

    Time frame: 15 months

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Collaborators

  • Medtronic

Registry information

Official study title

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

Acronym: ConnectOptiVol

Important dates

Study start
2007
Primary completion
2011
Study completion
2013
First posted
Aug 8, 2008
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.