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

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00730548
First received: June 19, 2008
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

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 Intervention
Heart Failure
Ventricular Tachycardia
Cardiac Desynchronization
Behavioral: Device triggered remote telephone contact because of Care Alert

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • Time to first hospitalization due to worsened heart failure [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time from device detected onset of arrhythmias, cardiovascular disease progression and system issues to clinical decision making [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Enrollment: 180
Study Start Date: November 2007
Study Completion Date: August 2013
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00730548

Locations
Germany
University Hospital of Goettingen
Goettingen, Germany, 37099
Sponsors and Collaborators
Medtronic Bakken Research Center
Medtronic
  More Information

No publications provided by Medtronic Bakken Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00730548     History of Changes
Other Study ID Numbers: CEN_G_CA_7
Study First Received: June 19, 2008
Last Updated: August 22, 2013
Health Authority: German Institute of Medical Documentation and Information: Germany

Additional relevant MeSH terms:
Heart Failure
Tachycardia
Tachycardia, Ventricular
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014