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

Remote Follow-up for ICD-Therapy in Patients Meeting MADIT II Criteria (REFORM)

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.

Study Overview

• Status: Completed
• Conditions: Ventricular Fibrillation; Ventricular Tachycardia
• Intervention / Treatment: Device: Implantable Cardioverter Defibrillator

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).

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Phase 4

Contacts and Locations

Study Locations

• Czech Republic
  • Praha, Czech Republic, 14021
    • Institute of clinical and experimental medicine
  • Praha, Czech Republic, 15030
    • Hospital Na Homolce
• Germany
  • Bad Berka, Germany, 99437
    • Zentralklinik Bad Berka
  • Bad Neustadt, Germany, 97616
    • Herz- und Gefäßklinikum Bad Neustadt GmbH
  • Leipzig, Germany, 04289
    • Herzzentrum der Universität Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Prolonged follow-up intervals every 12 months	Device: Implantable Cardioverter Defibrillator; ICD with Biotronik Home Monitoring capability; Other Names: 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 Names: Lexos VR-T, Lexos DR-T, Belos DR-T, Lumos VR-T

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of follow-up visits	27 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Total costs	27 months
Mortality from any cause	27 months
Quality of life (SF-36)	27 months
Hospitalization	27 months

Collaborators and Investigators

• Sponsor: Biotronik SE & Co. KG
• Investigators: Study Chair: Gerhard Hindricks, Prof. Dr., Herzzentrum Leipzig, Germany

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: November 17, 2006
• First Submitted That Met QC Criteria: November 17, 2006
• First Posted (Estimate): November 20, 2006

Study Record Updates

• Last Update Posted (Estimate): January 17, 2011
• Last Update Submitted That Met QC Criteria: January 14, 2011
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: home monitoring; prophylactic ICD therapy; follow-up interval; remote follow-up
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Ventricular Fibrillation; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: HS024