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

Heart Failure Clinical Trial

— ConnectOptiVol  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00730548
• Other study ID #: CEN_G_CA_7
• Status: Completed
• Phase: N/A
• First received: June 19, 2008
• Last updated: February 14, 2017
• Start date: November 2007
• Est. completion date: August 2013

Study information

• Verified date: February 2017
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: August 2013
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Desynchronization
• Heart Failure
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital of Goettingen	Goettingen

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center	Medtronic

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Lüthje L, Vollmann D, Seegers J, Sohns C, Hasenfuß G, Zabel M. A randomized study of remote monitoring and fluid monitoring for the management of patients with implanted cardiac arrhythmia devices. Europace. 2015 Aug;17(8):1276-81. doi: 10.1093/europace/e — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first hospitalization due to worsened heart failure		15 months
Secondary	Time from device detected onset of arrhythmias, cardiovascular disease progression and system issues to clinical decision making		15 months