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

NCT ID: NCT01200381

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2014-07-31

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

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

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

Group Type: ACTIVE_COMPARATOR

Quarterly remote follow ups and remote monitoring

Intervention Type: OTHER

Quarterly remote follow ups and remote monitoring

Group B1

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

Group Type: ACTIVE_COMPARATOR

Quarterly remote follow ups + additional phone calls and remote monitoring

Intervention Type: OTHER

Quarterly remote follow ups + additional phone calls and remote monitoring

Group B2

Personal ICD/CRTD follow up (Quarterly visits)

Group Type: ACTIVE_COMPARATOR

Quarterly in clinic follow ups and remote monitoring

Intervention Type: OTHER

Quarterly in clinic follow ups and remote monitoring

Interventions

Quarterly remote follow ups and remote monitoring

Quarterly remote follow ups and remote monitoring

Intervention Type: OTHER

Quarterly remote follow ups + additional phone calls and remote monitoring

Quarterly remote follow ups + additional phone calls and remote monitoring

Intervention Type: OTHER

Quarterly in clinic follow ups and remote monitoring

Quarterly in clinic follow ups and remote monitoring

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Weiss, Prof. Dr. med.

Role: STUDY_CHAIR

Städtisches Klinikum Lüneburg gGmbH

Locations

SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald

Bad Friedrichshall, , Germany

Asklepios Klinik Bad Oldesloe

Bad Oldesloe, , Germany

Segeberger Kliniken GmbH

Bad Segeberg, , Germany

Evangelisches Krankenhaus Bielefeld gGmbH

Bielefeld, , Germany

Evangelisches Krankenhaus Kalk

Cologne, , Germany

Universitätsklinikum Essen (AöR)

Essen, , Germany

Herzkatheterlabor der Kardiologischen Praxis am Krankenhaus Neu-Bethlehem gGmbH

Göttingen, , Germany

Asklepios Klinik St. Georg

Hamburg, , Germany

Asklepios Klinik Barmbek

Hamburg, , Germany

Klinikum Ingolstadt GmbH

Ingolstadt, , Germany

Kardiologische Praxis - Partnergesellschaft

Ludwigsburg, , Germany

Städtisches Klinikum Lüneburg gGmbH

Lüneburg, , Germany

Marienhaus Klinikum St. Elisabeth-Krankenhaus

Neuwied, , Germany

Praxis Dr. med. Balbach / Ruppert

Nürtingen, , Germany

Kardiologische Gemeinschaftspraxis am Park Sanssouci

Potsdam, , Germany

Klinikum Sindelfingen-Böblingen gGmbH

Sindelfingen, , Germany

Marienhospital Stuttgart

Stuttgart, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 29954340 (View on PubMed)

Other Identifiers

T94

Identifier Type: -

Identifier Source: org_study_id