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

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ClinicalTrials.gov Identifier: NCT00730548
Recruitment Status : Completed
First Posted : August 8, 2008
Last Update Posted : February 15, 2017
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Heart Failure Ventricular Tachycardia Cardiac Desynchronization Behavioral: Device triggered remote telephone contact because of Care Alert Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : November 2007
Actual Primary Completion Date : April 2011
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Remote Arm (OptiVol plus Connexus Telemetry plus CareLink plus Intervention Algorithm), Clinical Management Alerts ON
Behavioral: Device 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
Other Names:
  • OptiVol
  • CareLink
  • Medtronic Concerto
  • Medtronic Consulta
  • Medtronic Secura
  • Medtronic Virtuoso
No Intervention: 2
No Care Alerts available, standard treatment of the patient



Primary Outcome Measures :
  1. Time to first hospitalization due to worsened heart failure [ Time Frame: 15 months ]

Secondary Outcome Measures :
  1. Time from device detected onset of arrhythmias, cardiovascular disease progression and system issues to clinical decision making [ Time Frame: 15 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00730548


Locations
Germany
University Hospital of Goettingen
Goettingen, Germany, 37099
Sponsors and Collaborators
Medtronic Bakken Research Center
Medtronic
Investigators
Principal Investigator: Markus Zabel, MD University Hospital of Goettingen