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INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients With Remotely Monitored Implanted Cardioverter Defibrillators (ICD) SysTems (InContact)

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Quarterly remote follow ups and remote monitoring
Quarterly remote follow ups + additional phone calls and remote monitoring
Quarterly in clinic follow ups and remote monitoring
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring ICD, CRTD, Remote care, Remote monitoring, Heart failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Indication for implantation (new, boxchange, upgrade) of ICD/ CRT-D
  • Written informed consent
  • Ejection Fraction <= 35%
  • New York Heart Association (NYHA) Class I-III
  • Age >=18 and <=80 years
  • In patient's home environment sufficient infrastructure (analog phone line or sufficient strength of GSM (Global System for Mobile communication) mobile phone network) for running a Merlin@home transmitter is available

Exclusion Criteria:

  • Arterio ventricular (AV) Block III / AV Block II Type Mobitz
  • Severe renal insufficiency
  • Coronary angiology intervention within previous 3 months
  • Myocardial infarction within previous month
  • Life expectancy < 1 year
  • Expected poor data quality / compliance
  • Pregnancy
  • Patient is already participating to another study with active therapy arm

Sites / Locations

  • SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald
  • Asklepios Klinik Bad Oldesloe
  • Segeberger Kliniken GmbH
  • Evangelisches Krankenhaus Bielefeld gGmbH
  • Universitätsklinikum Essen (AöR)
  • Herzkatheterlabor der Kardiologischen Praxis am Krankenhaus Neu-Bethlehem gGmbH
  • Asklepios Klinik St. Georg
  • Asklepios Klinik Barmbek
  • Klinikum Ingolstadt GmbH
  • Evangelisches Krankenhaus Kalk
  • Kardiologische Praxis - Partnergesellschaft
  • Städtisches Klinikum Lüneburg gGmbH
  • Marienhaus Klinikum St. Elisabeth-Krankenhaus
  • Praxis Dr. med. Balbach / Ruppert
  • Kardiologische Gemeinschaftspraxis am Park Sanssouci
  • Klinikum Sindelfingen-Böblingen gGmbH
  • Marienhospital Stuttgart

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group A

Group B1

Group B2

Arm Description

Automatic anonymous ICD/CRTD follow up (quarterly remote follow ups)

Personal ICD/CRTD follow up (phone calls + quarterly remote follow ups)

Personal ICD/CRTD follow up (Quarterly visits)

Outcomes

Primary Outcome Measures

Amount of patients with worsened outcome in reference to Packer's "Heart Failure Clinical Composite Response"

Secondary Outcome Measures

Mortality
Heart failure hospitalizations
Cardiovascular events
Number of additional, unscheduled follow ups
Number of follow ups with relevant findings
Number of delivered / appropriate ICD therapies
Quality of life (MLHFQ)

Full Information

First Posted
September 10, 2010
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT01200381
Brief Title
INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients With Remotely Monitored Implanted Cardioverter Defibrillators (ICD) SysTems
Acronym
InContact
Official Title
INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients With Remotely Monitored ICD SysTems
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
It's the aim of this study to analyze the benefit of personal patient / physician contacts in heart failure patients with remotely monitored implanted cardioverter defibrillators (ICD) or ICD with cardiac resynchronization therapy (CRT-D). The personal follow up (in clinic or phone calls) will be compared to completely automatic remote follow ups. All patients will receive remote monitoring for automatic daily alarm checks and will undergo in clinic follow ups in 12 months intervals

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
ICD, CRTD, Remote care, Remote monitoring, Heart failure

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Automatic anonymous ICD/CRTD follow up (quarterly remote follow ups)
Arm Title
Group B1
Arm Type
Active Comparator
Arm Description
Personal ICD/CRTD follow up (phone calls + quarterly remote follow ups)
Arm Title
Group B2
Arm Type
Active Comparator
Arm Description
Personal ICD/CRTD follow up (Quarterly visits)
Intervention Type
Other
Intervention Name(s)
Quarterly remote follow ups and remote monitoring
Intervention Description
Quarterly remote follow ups and remote monitoring
Intervention Type
Other
Intervention Name(s)
Quarterly remote follow ups + additional phone calls and remote monitoring
Intervention Description
Quarterly remote follow ups + additional phone calls and remote monitoring
Intervention Type
Other
Intervention Name(s)
Quarterly in clinic follow ups and remote monitoring
Intervention Description
Quarterly in clinic follow ups and remote monitoring
Primary Outcome Measure Information:
Title
Amount of patients with worsened outcome in reference to Packer's "Heart Failure Clinical Composite Response"
Time Frame
12 months (between 1 and 13 months post implant)
Secondary Outcome Measure Information:
Title
Mortality
Time Frame
12 months (between 1 and 13 months post implant)
Title
Heart failure hospitalizations
Time Frame
12 months (between 1 and 13 months post implant)
Title
Cardiovascular events
Time Frame
12 months (between 1 and 13 months post implant)
Title
Number of additional, unscheduled follow ups
Time Frame
12 months (between 1 and 13 months post implant)
Title
Number of follow ups with relevant findings
Time Frame
12 months (between 1 and 13 months post implant)
Title
Number of delivered / appropriate ICD therapies
Time Frame
12 months (between 1 and 13 months post implant)
Title
Quality of life (MLHFQ)
Time Frame
12 months (between 1 and 13 months post implant)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Indication for implantation (new, boxchange, upgrade) of ICD/ CRT-D Written informed consent Ejection Fraction <= 35% New York Heart Association (NYHA) Class I-III Age >=18 and <=80 years In patient's home environment sufficient infrastructure (analog phone line or sufficient strength of GSM (Global System for Mobile communication) mobile phone network) for running a Merlin@home transmitter is available Exclusion Criteria: Arterio ventricular (AV) Block III / AV Block II Type Mobitz Severe renal insufficiency Coronary angiology intervention within previous 3 months Myocardial infarction within previous month Life expectancy < 1 year Expected poor data quality / compliance Pregnancy Patient is already participating to another study with active therapy arm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Weiss, Prof. Dr. med.
Organizational Affiliation
Städtisches Klinikum Lüneburg gGmbH
Official's Role
Study Chair
Facility Information:
Facility Name
SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald
City
Bad Friedrichshall
ZIP/Postal Code
74177
Country
Germany
Facility Name
Asklepios Klinik Bad Oldesloe
City
Bad Oldesloe
ZIP/Postal Code
23843
Country
Germany
Facility Name
Segeberger Kliniken GmbH
City
Bad Segeberg
ZIP/Postal Code
23795
Country
Germany
Facility Name
Evangelisches Krankenhaus Bielefeld gGmbH
City
Bielefeld
ZIP/Postal Code
33617
Country
Germany
Facility Name
Universitätsklinikum Essen (AöR)
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Herzkatheterlabor der Kardiologischen Praxis am Krankenhaus Neu-Bethlehem gGmbH
City
Göttingen
ZIP/Postal Code
37073
Country
Germany
Facility Name
Asklepios Klinik St. Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Asklepios Klinik Barmbek
City
Hamburg
ZIP/Postal Code
22307
Country
Germany
Facility Name
Klinikum Ingolstadt GmbH
City
Ingolstadt
ZIP/Postal Code
85049
Country
Germany
Facility Name
Evangelisches Krankenhaus Kalk
City
Köln
ZIP/Postal Code
51103
Country
Germany
Facility Name
Kardiologische Praxis - Partnergesellschaft
City
Ludwigsburg
ZIP/Postal Code
71634
Country
Germany
Facility Name
Städtisches Klinikum Lüneburg gGmbH
City
Lüneburg
ZIP/Postal Code
21339
Country
Germany
Facility Name
Marienhaus Klinikum St. Elisabeth-Krankenhaus
City
Neuwied
ZIP/Postal Code
56564
Country
Germany
Facility Name
Praxis Dr. med. Balbach / Ruppert
City
Nürtingen
ZIP/Postal Code
72622
Country
Germany
Facility Name
Kardiologische Gemeinschaftspraxis am Park Sanssouci
City
Potsdam
ZIP/Postal Code
14471
Country
Germany
Facility Name
Klinikum Sindelfingen-Böblingen gGmbH
City
Sindelfingen
ZIP/Postal Code
71065
Country
Germany
Facility Name
Marienhospital Stuttgart
City
Stuttgart
ZIP/Postal Code
70199
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
29954340
Citation
Hansen C, Loges C, Seidl K, Eberhardt F, Troster H, Petrov K, Gronefeld G, Bramlage P, Birkenhauer F, Weiss C. INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients with Remotely Monitored Implanted Cardioverter Defibrillators SysTems (InContact). BMC Cardiovasc Disord. 2018 Jun 28;18(1):131. doi: 10.1186/s12872-018-0864-7.
Results Reference
derived

Learn more about this trial

INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients With Remotely Monitored Implanted Cardioverter Defibrillators (ICD) SysTems

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