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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00730548
First Posted: August 8, 2008
Last Update Posted: February 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Bakken Research Center
  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
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

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 ]

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Publications:
Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00730548     History of Changes
Other Study ID Numbers: CEN_G_CA_7
First Submitted: June 19, 2008
First Posted: August 8, 2008
Last Update Posted: February 15, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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