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Ventricular FibrillationPhase 4REFORMNCT00401466

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

A Phase 4 study testing Implantable Cardioverter Defibrillator in people with Ventricular Fibrillation and Ventricular Tachycardia, run by Biotronik SE & Co. KG at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Implantable Cardioverter Defibrillator
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
155 participants
Where
5 sitesin 2 countries
Study dates
Jan 2004to Jul 2008
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Germany3 sites

  • Zentralklinik Bad Berka

    Bad Berka, 99437

  • Herz- und Gefäßklinikum Bad Neustadt GmbH

    Bad Neustadt an der Saale, 97616

  • Herzzentrum der Universität Leipzig

    Leipzig, 04289

Other trials in Germany

Czechia2 sites

  • Institute of clinical and experimental medicine

    Prague, 14021

  • Hospital Na Homolce

    Prague, 15030

Other trials in Czechia

About this study

Official title: 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.

Read the 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).

Being tested
Implantable Cardioverter Defibrillator
Keywords
prophylactic ICD therapy, home monitoring, follow-up interval, remote follow-up
Medical subject headings
Ventricular Fibrillation, Tachycardia, Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implantable Cardioverter DefibrillatorDevice

    Also called Lexos VR-T, Lexos DR-T, Belos DR-T, Lumos VR-T

    ICD with Biotronik Home Monitoring capability

Study groups in NCT00401466
Study groupRoleWhat they receive
1ExperimentalProlonged follow-up intervals every 12 months
Receives: Device: Implantable Cardioverter Defibrillator
2Active comparatorStandard follow-up intervals of 3 months
Receives: Device: Implantable Cardioverter Defibrillator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of follow-up visits

    Measured: 27 months

Secondary outcomes (4)

  1. Total costs

    Measured: 27 months

  2. Mortality from any cause

    Measured: 27 months

  3. Quality of life (SF-36)

    Measured: 27 months

  4. Hospitalization

    Measured: 27 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2006 (estimated)
  2. Study startJan 2004
  3. Primary completionJul 2008
  4. Study completionJul 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00401466
Sponsor's protocol ID
HS024
Acronym
REFORM
Status last verified
Jul 2008
First submitted
17 Nov 2006
Last updated
17 Jan 2011
Results posted
No
Data monitoring committee
No

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.

    PubMed 23868932

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Implantable Cardioverter Defibrillator in people with Ventricular Fibrillation and Ventricular Tachycardia, run by Biotronik SE & Co. KG at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of follow-up visits (time frame: 27 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00401466, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2011.

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