Remote Follow-up of Patients Receiving Implantable Cardioverter Defibrillator for Prophylactic Therapy (REFORM)

This study has been completed.
Sponsor:
Information provided by:
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT00401466
First received: November 17, 2006
Last updated: January 14, 2011
Last verified: July 2008
  Purpose

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.


Condition Intervention Phase
Ventricular Fibrillation
Ventricular Tachycardia
Device: Implantable Cardioverter Defibrillator
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Remote Follow-up for ICD-Therapy in Patients Meeting MADIT II Criteria (REFORM)

Resource links provided by NLM:


Further study details as provided by Biotronik SE & Co. KG:

Primary Outcome Measures:
  • Number of follow-up visits [ Time Frame: 27 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total costs [ Time Frame: 27 months ] [ Designated as safety issue: No ]
  • Mortality from any cause [ Time Frame: 27 months ] [ Designated as safety issue: Yes ]
  • Quality of life (SF-36) [ Time Frame: 27 months ] [ Designated as safety issue: No ]
  • Hospitalization [ Time Frame: 27 months ] [ Designated as safety issue: Yes ]

Enrollment: 155
Study Start Date: January 2004
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Prolonged follow-up intervals every 12 months
Device: Implantable Cardioverter Defibrillator
ICD with Biotronik Home Monitoring capability
Other Name: Lexos VR-T, Lexos DR-T, Belos DR-T, Lumos VR-T
Active Comparator: 2
Standard follow-up intervals of 3 months
Device: Implantable Cardioverter Defibrillator
ICD with Biotronik Home Monitoring capability
Other Name: Lexos VR-T, Lexos DR-T, Belos DR-T, Lumos VR-T

Detailed Description:

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 1st therapy due to ventricular tachyarrhythmia was about 34% within 3 years, with an increasing incidence from year 1 to 3. 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 automatically transmits predefined parameters on a daily basis from the implanted devices to a web-based platform accessible only by registered patients' physicians. These data may substitute in-clinical 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.

The patients should receive single- or dual-chamber ICD models with the HM function.

The pre-hospital-discharge protocol comprises standard ICD follow-up + specific ICD programming, and activation of the HM function. The 1st standard follow-up visit is performed 3 months after the pre-discharge control. At this visit the patients are randomized to 3- vs. 12-month follow-up scheme. For the 3-month follow-up group, routine visits are scheduled at 6, 9, 12, 15, 18, 21, 24, and 27 months after patient discharge. For the 12-month (remote) follow-up group, routine visits are scheduled at 15 and 27 months after discharge. In either group, additional visits are scheduled on patient demand, due to device or lead problems, or due to the following Cardio Report (Home Monitoring) findings: Elective ICD replacement point, the 1st shock after discharge, an ineffective shock, ineffective anti-tachycardia pacing, ventricular pacing impedance outside the pre-defined range, shock impedance lower than 25 Ohm or greater than 110 Ohm, frequent arrhythmia episodes (according to pre-specified criteria).

  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 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

Exclusion Criteria:

  • 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
  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: NCT00401466

Locations
Czech Republic
Institute of clinical and experimental medicine
Praha, Czech Republic, 14021
Hospital Na Homolce
Praha, Czech Republic, 15030
Germany
Zentralklinik Bad Berka
Bad Berka, Germany, 99437
Herz- und Gefäßklinikum Bad Neustadt GmbH
Bad Neustadt, Germany, 97616
Herzzentrum der Universität Leipzig
Leipzig, Germany, 04289
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
Study Chair: Gerhard Hindricks, Prof. Dr. Herzzentrum Leipzig, Germany
  More Information

Publications:
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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jochen Proff, Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT00401466     History of Changes
Other Study ID Numbers: HS024
Study First Received: November 17, 2006
Last Updated: January 14, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Biotronik SE & Co. KG:
prophylactic ICD therapy
home monitoring
follow-up interval
remote follow-up

Additional relevant MeSH terms:
Tachycardia
Ventricular Fibrillation
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014