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

NCT00730548 | Completed

• 1 other identifier: CEN_G_CA_7
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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).

Conditions

Heart Failure; Ventricular Tachycardia; Cardiac Desynchronization

Outcome Measures

Primary Outcomes (1)

• Time to first hospitalization due to worsened heart failure

  15 months

Secondary Outcomes (1)

• Time from device detected onset of arrhythmias, cardiovascular disease progression and system issues to clinical decision making

  15 months

Study Arms (2)

1

EXPERIMENTAL

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

2

NO INTERVENTION

No Care Alerts available, standard treatment of the patient

Interventions

Device triggered remote telephone contact because of Care Alert BEHAVIORAL

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

Also known as: OptiVol, CareLink, Medtronic Concerto, Medtronic Consulta, Medtronic Secura, Medtronic Virtuoso

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Permanent AF
• Less than 18 years of age
• Life expectancy less than 15 months
• Participation in another clinical study
• Pregnancy

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead
• Medtronic: collaborator

Study Sites (1)

University Hospital of Goettingen

Göttingen, 37099, Germany

Location

Related Publications (2)

• Zabel M, Vollmann D, Luthje 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.

  PMID: 23073567 BACKGROUND

• Luthje 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/euv039. Epub 2015 May 17.

  PMID: 25983310 RESULT

MeSH Terms

Conditions

Heart Failure; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Tachycardia; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Markus Zabel, MD

  University Hospital of Goettingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2008
• First Posted: August 8, 2008
• Study Start: November 1, 2007
• Primary Completion: April 1, 2011
• Study Completion: August 1, 2013
• Last Updated: July 3, 2025

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)