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Sponsored by: |
Biotronik SE & Co. KG |
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Information provided by: | Biotronik SE & Co. KG |
ClinicalTrials.gov Identifier: | NCT00401466 |
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 |
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Ventricular Fibrillation Ventricular Tachycardia |
Device: Implantable Cardioverter Defibrillator |
Phase IV |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Remote Follow-up for ICD-Therapy in Patients Meeting MADIT II Criteria (REFORM) |
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 |
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1: Experimental
Prolonged follow-up intervals every 12 months
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Device: Implantable Cardioverter Defibrillator
ICD with Biotronik Home Monitoring capability
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2: Active Comparator
Standard follow-up intervals of 3 months
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Device: Implantable Cardioverter Defibrillator
ICD with Biotronik Home Monitoring capability
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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).
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Indication for implantation of an implantable cardioverter-defibrillator (ICD) according to the patient selection criteria used in the MADIT-II trial:
Exclusion Criteria:
Czech Republic | |
Institute of clinical and experimental medicine | |
Praha, Czech Republic, 14021 | |
Hospital Na Homolce | |
Praha, Czech Republic, 15030 | |
Germany | |
Herzzentrum der Universität Leipzig | |
Leipzig, Germany, 04289 | |
Zentralklinik Bad Berka | |
Bad Berka, Germany, 99437 | |
Herz- und Gefäßklinikum Bad Neustadt GmbH | |
Bad Neustadt, Germany, 97616 |
Study Chair: | Gerhard Hindricks, Prof. Dr. | Herzzentrum Leipzig, Germany |
Responsible Party: | Biotronik GmbH & Co. KG ( Dr. Heinrich Moertel ) |
Study ID Numbers: | HS024 |
Study First Received: | November 17, 2006 |
Last Updated: | July 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00401466 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
prophylactic ICD therapy home monitoring follow-up interval remote follow-up |
Paroxysmal Ventricular Fibrillation Heart Diseases Tachycardia |
Tachycardia, Ventricular Ventricular Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Heart Diseases Tachycardia Cardiovascular Diseases |
Tachycardia, Ventricular Ventricular Fibrillation Arrhythmias, Cardiac |