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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01200381
First received: September 10, 2010
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

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 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


Condition Intervention
Heart Failure
Other: Quarterly remote follow ups and remote monitoring
Other: Quarterly remote follow ups + additional phone calls and remote monitoring
Other: Quarterly in clinic follow ups and remote monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients With Remotely Monitored ICD SysTems

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: 12 months (between 1 and 13 months post implant) ] [ Designated as safety issue: Yes ]
  • Heart failure hospitalizations [ Time Frame: 12 months (between 1 and 13 months post implant) ] [ Designated as safety issue: No ]
  • Cardiovascular events [ Time Frame: 12 months (between 1 and 13 months post implant) ] [ Designated as safety issue: No ]
  • Number of additional, unscheduled follow ups [ Time Frame: 12 months (between 1 and 13 months post implant) ] [ Designated as safety issue: No ]
  • Number of follow ups with relevant findings [ Time Frame: 12 months (between 1 and 13 months post implant) ] [ Designated as safety issue: No ]
  • Number of delivered / appropriate ICD therapies [ Time Frame: 12 months (between 1 and 13 months post implant) ] [ Designated as safety issue: No ]
  • Quality of life (MLHFQ) [ Time Frame: 12 months (between 1 and 13 months post implant) ] [ Designated as safety issue: No ]

Enrollment: 210
Study Start Date: February 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A
Automatic anonymous ICD/CRTD follow up (quarterly remote follow ups)
Other: Quarterly remote follow ups and remote monitoring
Quarterly remote follow ups and remote monitoring
Active Comparator: Group B1
Personal ICD/CRTD follow up (phone calls + quarterly remote follow ups)
Other: Quarterly remote follow ups + additional phone calls and remote monitoring
Quarterly remote follow ups + additional phone calls and remote monitoring
Active Comparator: Group B2
Personal ICD/CRTD follow up (Quarterly visits)
Other: Quarterly in clinic follow ups and remote monitoring
Quarterly in clinic follow ups and remote monitoring

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200381

Locations
Germany
SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald
Bad Friedrichshall, Germany, 74177
Asklepios Klinik Bad Oldesloe
Bad Oldesloe, Germany, 23843
Segeberger Kliniken GmbH
Bad Segeberg, Germany, 23795
Evangelisches Krankenhaus Bielefeld gGmbH
Bielefeld, Germany, 33617
Universitätsklinikum Essen (AöR)
Essen, Germany, 45122
Herzkatheterlabor der Kardiologischen Praxis am Krankenhaus Neu-Bethlehem gGmbH
Göttingen, Germany, 37073
Asklepios Klinik Barmbek
Hamburg, Germany, 22307
Asklepios Klinik St. Georg
Hamburg, Germany, 20099
Klinikum Ingolstadt GmbH
Ingolstadt, Germany, 85049
Evangelisches Krankenhaus Kalk
Köln, Germany, 51103
Kardiologische Praxis - Partnergesellschaft
Ludwigsburg, Germany, 71634
Städtisches Klinikum Lüneburg gGmbH
Lüneburg, Germany, 21339
Marienhaus Klinikum St. Elisabeth-Krankenhaus
Neuwied, Germany, 56564
Praxis Dr. med. Balbach / Ruppert
Nürtingen, Germany, 72622
Kardiologische Gemeinschaftspraxis am Park Sanssouci
Potsdam, Germany, 14471
Klinikum Sindelfingen-Böblingen gGmbH
Sindelfingen, Germany, 71065
Marienhospital Stuttgart
Stuttgart, Germany, 70199
Sponsors and Collaborators
St. Jude Medical
Investigators
Study Chair: Christian Weiss, Prof. Dr. med. Städtisches Klinikum Lüneburg gGmbH
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01200381     History of Changes
Other Study ID Numbers: T94
Study First Received: September 10, 2010
Last Updated: July 26, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by St. Jude Medical:
ICD
CRTD
Remote care
Remote monitoring
Heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014