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

Ventricular Tachycardia Clinical Trial

— REFORM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401466
• Other study ID #: HS024
• Status: Completed
• Phase: Phase 4
• First received: November 17, 2006
• Last updated: January 14, 2011
• Start date: January 2004
• Est. completion date: July 2008

Study information

• Verified date: July 2008
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Fibrillation
• Ventricular Tachycardia

Intervention

Device:
• Implantable Cardioverter Defibrillator
ICD with Biotronik Home Monitoring capability

Locations

Country	Name	City	State
Czech Republic	Hospital Na Homolce	Praha
Czech Republic	Institute of clinical and experimental medicine	Praha
Germany	Zentralklinik Bad Berka	Bad Berka
Germany	Herz- und Gefäßklinikum Bad Neustadt GmbH	Bad Neustadt
Germany	Herzzentrum der Universität Leipzig	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Czech Republic,  Germany, 

References & Publications (1)

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 imp

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of follow-up visits		27 months	No
Secondary	Total costs		27 months	No
Secondary	Mortality from any cause		27 months	Yes
Secondary	Quality of life (SF-36)		27 months	No
Secondary	Hospitalization		27 months	Yes