INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients With Remotely Monitored Implanted Cardioverter Defibrillators (ICD) SysTems
InContact
1 other identifier
interventional
210
1 country
17
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable heart-failure
Started Feb 2010
Longer than P75 for not_applicable heart-failure
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 10, 2010
CompletedFirst Posted
Study publicly available on registry
September 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedFebruary 4, 2019
February 1, 2019
4.4 years
September 10, 2010
February 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Amount of patients with worsened outcome in reference to Packer's "Heart Failure Clinical Composite Response"
12 months (between 1 and 13 months post implant)
Secondary Outcomes (7)
Mortality
12 months (between 1 and 13 months post implant)
Heart failure hospitalizations
12 months (between 1 and 13 months post implant)
Cardiovascular events
12 months (between 1 and 13 months post implant)
Number of additional, unscheduled follow ups
12 months (between 1 and 13 months post implant)
Number of follow ups with relevant findings
12 months (between 1 and 13 months post implant)
- +2 more secondary outcomes
Study Arms (3)
Group A
ACTIVE COMPARATORAutomatic anonymous ICD/CRTD follow up (quarterly remote follow ups)
Group B1
ACTIVE COMPARATORPersonal ICD/CRTD follow up (phone calls + quarterly remote follow ups)
Group B2
ACTIVE COMPARATORPersonal ICD/CRTD follow up (Quarterly visits)
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald
Bad Friedrichshall, 74177, Germany
Asklepios Klinik Bad Oldesloe
Bad Oldesloe, 23843, Germany
Segeberger Kliniken GmbH
Bad Segeberg, 23795, Germany
Evangelisches Krankenhaus Bielefeld gGmbH
Bielefeld, 33617, Germany
Evangelisches Krankenhaus Kalk
Cologne, 51103, Germany
Universitätsklinikum Essen (AöR)
Essen, 45122, Germany
Herzkatheterlabor der Kardiologischen Praxis am Krankenhaus Neu-Bethlehem gGmbH
Göttingen, 37073, Germany
Asklepios Klinik St. Georg
Hamburg, 20099, Germany
Asklepios Klinik Barmbek
Hamburg, 22307, Germany
Klinikum Ingolstadt GmbH
Ingolstadt, 85049, Germany
Kardiologische Praxis - Partnergesellschaft
Ludwigsburg, 71634, Germany
Städtisches Klinikum Lüneburg gGmbH
Lüneburg, 21339, Germany
Marienhaus Klinikum St. Elisabeth-Krankenhaus
Neuwied, 56564, Germany
Praxis Dr. med. Balbach / Ruppert
Nürtingen, 72622, Germany
Kardiologische Gemeinschaftspraxis am Park Sanssouci
Potsdam, 14471, Germany
Klinikum Sindelfingen-Böblingen gGmbH
Sindelfingen, 71065, Germany
Marienhospital Stuttgart
Stuttgart, 70199, Germany
Related Publications (1)
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.
PMID: 29954340DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Christian Weiss, Prof. Dr. med.
Städtisches Klinikum Lüneburg gGmbH
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
September 10, 2010
First Posted
September 13, 2010
Study Start
February 1, 2010
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
February 4, 2019
Record last verified: 2019-02