NCT00401466

Brief Summary

The completed MADIT II study has shown that implantation of a cardioverter-defibrillator (ICD) in patients with a reduced left ventricular ejection fraction and a prior myocardial infarction reduces death from any cause. The probability of the first therapy due to ventricular tachyarrhythmia was about 34% within 3 years. With a 3-month ICD-follow-up scheme, as it is in the standard ICD therapy, the majority of patients is followed more closely than necessary with respect to anti-tachyarrhythmia ICD therapy. A Home Monitoring (HM) function has been integrated into several ICD models from Biotronik (Berlin , Germany), for close remote monitoring of ICD patients. The HM function may substitute in-clinic follow-up controls. The objective of our study is to compare a standard 3-month follow-up scheme and a 12-month follow-up scheme using HM in ICD recipients with the "MADIT II indications". The comparison should be made with respect to the difference in follow-up burden and the associated costs, and regarding possible impact of the remote follow-up via HM on all cause mortality, hospitalization, and patients' quality of life.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_4

Geographic Reach
2 countries

5 active sites

Status
completed

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

January 1, 2004

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

January 17, 2011

Status Verified

July 1, 2008

Enrollment Period

4.5 years

First QC Date

November 17, 2006

Last Update Submit

January 14, 2011

Conditions

Ventricular FibrillationVentricular Tachycardia

Keywords

prophylactic ICD therapyhome monitoringfollow-up intervalremote follow-up

Outcome Measures

Primary Outcomes (1)

  • Number of follow-up visits

    27 months

Secondary Outcomes (4)

  • Total costs

    27 months

  • Mortality from any cause

    27 months

  • Quality of life (SF-36)

    27 months

  • Hospitalization

    27 months

Study Arms (2)

1

EXPERIMENTAL

Prolonged follow-up intervals every 12 months

Device: Implantable Cardioverter Defibrillator

2

ACTIVE COMPARATOR

Standard follow-up intervals of 3 months

Device: Implantable Cardioverter Defibrillator

Interventions

Implantable Cardioverter DefibrillatorDEVICE

ICD with Biotronik Home Monitoring capability

Also known as: Lexos VR-T, Lexos DR-T, Belos DR-T, Lumos VR-T
12

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for implantation of an implantable cardioverter-defibrillator (ICD) according to the patient selection criteria used in the MADIT-II trial:
  • Myocardial infarction 1 month or more prior to entry
  • Ejection fraction of 30% or less within 3 months before entry

You may not qualify if:

  • NYHA functional class IV
  • Coronary revascularization later than 5 days after ICD implantation
  • First myocardial infarction within the past month
  • Advanced cerebrovascular disease
  • Any condition with a likelihood of death within the next 12 months
  • Pacing indication
  • Conventional ICD indication (i.e., criteria other than MADIT II)
  • Living in an area with insufficient GSM coverage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Institute of clinical and experimental medicine

Prague, 14021, Czechia

Location

Hospital Na Homolce

Prague, 15030, Czechia

Location

Zentralklinik Bad Berka

Bad Berka, 99437, Germany

Location

Herz- und Gefäßklinikum Bad Neustadt GmbH

Bad Neustadt an der Saale, 97616, Germany

Location

Herzzentrum der Universität Leipzig

Leipzig, 04289, Germany

Location

Related Publications (2)

  • Elsner C, Sommer P, Piorkowski C, Taborsky M, Neuser H, Bytesnik J, Geller J, Kottkamp H, Wiesmeth H, Hindricks G. A prospective multicenter comparison trial of Home Monitoring against regular follow-up in MADIT II patients: additional visits and cost impact. Comput Cardiol 33: 241-244, 2006.

    RESULT

  • Hindricks G, Elsner C, Piorkowski C, Taborsky M, Geller JC, Schumacher B, Bytesnik J, Kottkamp H. Quarterly vs. yearly clinical follow-up of remotely monitored recipients of prophylactic implantable cardioverter-defibrillators: results of the REFORM trial. Eur Heart J. 2014 Jan;35(2):98-105. doi: 10.1093/eurheartj/eht207. Epub 2013 Jul 18.

    PMID: 23868932DERIVED

MeSH Terms

Conditions

Ventricular FibrillationTachycardia, Ventricular

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsTachycardiaCardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

DefibrillatorsElectrodesElectrical Equipment and SuppliesEquipment and SuppliesElectrodes, ImplantedProstheses and Implants

Study Officials

  • Gerhard Hindricks, Prof. Dr.

    Herzzentrum Leipzig, Germany

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 17, 2006

First Posted

November 20, 2006

Study Start

January 1, 2004

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

January 17, 2011

Record last verified: 2008-07

Locations

CZ(2)DE(3)