Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-26 @ 2:46 PM
Study NCT ID:
NCT00401466
Status:
COMPLETED
Last Update Posted:
2011-01-17
First Post:
2006-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remote Follow-up of Patients Receiving Implantable Cardioverter Defibrillator for Prophylactic Therapy
Sponsor:
Biotronik SE & Co. KG
Organization:
Study Overview
Official Title:
Remote Follow-up for ICD-Therapy in Patients Meeting MADIT II Criteria (REFORM)
Status:
COMPLETED
Status Verified Date:
2008-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REFORM
Brief 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.
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.
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: