Remote Follow-up of Patients Receiving Implantable Cardioverter Defibrillator for Prophylactic Therapy (REFORM)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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) |
- Number of follow-up visits [ Time Frame: 27 months ] [ Designated as safety issue: No ]
- 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 |
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| 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 | |
| Study Chair: | Gerhard Hindricks, Prof. Dr. | Herzzentrum Leipzig, Germany |
More Information
Publications:
| 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 May 16, 2013