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

June 19, 2008
August 22, 2013
November 2007
April 2011   (final data collection date for primary outcome measure)
Time to first hospitalization due to worsened heart failure [ Time Frame: 15 months ] [ Designated as safety issue: No ]
Hospital length of stay due to worsened heart failure [ Time Frame: 15 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00730548 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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

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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Heart Failure
  • Ventricular Tachycardia
  • Cardiac Desynchronization
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
  • Experimental: 1
    Remote Arm (OptiVol plus Connexus Telemetry plus CareLink plus Intervention Algorithm), Clinical Management Alerts ON
    Intervention: Behavioral: Device triggered remote telephone contact because of Care Alert
  • No Intervention: 2
    No Care Alerts available, standard treatment of the patient
Zabel M, Vollmann D, Lüthje L, Seegers J, Sohns C, Zenker D, Hasenfuss G. Randomized Clinical evaluatiON of wireless fluid monitoriNg and rEmote ICD managemenT using OptiVol alert-based predefined management to reduce cardiac decompensation and health care utilization: the CONNECT-OptiVol study. Contemp Clin Trials. 2013 Jan;34(1):109-16. doi: 10.1016/j.cct.2012.10.001. Epub 2012 Oct 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
August 2013
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00730548
CEN_G_CA_7
No
Medtronic Bakken Research Center
Medtronic Bakken Research Center
Medtronic
Not Provided
Medtronic Bakken Research Center
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP