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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)

Primary Purpose

Heart Failure, Ventricular Tachycardia, Cardiac Desynchronization

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Device triggered remote telephone contact because of Care Alert
Sponsored by
Medtronic Bakken Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Goettingen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Remote Arm (OptiVol plus Connexus Telemetry plus CareLink plus Intervention Algorithm), Clinical Management Alerts ON

No Care Alerts available, standard treatment of the patient

Outcomes

Primary Outcome Measures

Time to first hospitalization due to worsened heart failure

Secondary Outcome Measures

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

Full Information

First Posted
June 19, 2008
Last Updated
February 14, 2017
Sponsor
Medtronic Bakken Research Center
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT00730548
Brief Title
Compare Remote Patient Management and Standard Care in CRT-D and ICD-patients to Assess the Effect on Heart Failure
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Bakken Research Center
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Ventricular Tachycardia, Cardiac Desynchronization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Remote Arm (OptiVol plus Connexus Telemetry plus CareLink plus Intervention Algorithm), Clinical Management Alerts ON
Arm Title
2
Arm Type
No Intervention
Arm Description
No Care Alerts available, standard treatment of the patient
Intervention Type
Behavioral
Intervention Name(s)
Device triggered remote telephone contact because of Care Alert
Other Intervention Name(s)
OptiVol, CareLink, Medtronic Concerto, Medtronic Consulta, Medtronic Secura, Medtronic Virtuoso
Intervention Description
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
Primary Outcome Measure Information:
Title
Time to first hospitalization due to worsened heart failure
Time Frame
15 months
Secondary Outcome Measure Information:
Title
Time from device detected onset of arrhythmias, cardiovascular disease progression and system issues to clinical decision making
Time Frame
15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Zabel, MD
Organizational Affiliation
University Hospital of Goettingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Goettingen
City
Goettingen
ZIP/Postal Code
37099
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23073567
Citation
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.
Results Reference
background
PubMed Identifier
25983310
Citation
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.
Results Reference
result

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

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