The Patient Meets ACC/AHA/ESC Guidelines for Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) DeviceREACTNCT01090349
Clinical Evaluation Of Remote Monitoring With Direct Alerts To Reduce Time From Event To Clinical Decision
A study testing Implantation of an ICD/CRT-D device and Merlin.NET PCN in people with The Patient Meets ACC/AHA/ESC Guidelines for Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) Device, run by Abbott Medical Devices at 2 sites in 2 countries.
Trial summary
St. Jude Medical developed the Merlin.net™ Patient Care Network (Merlin.net™ PCN) to augment or replace routine scheduled in-clinic visits. This investigation is designed with the hypothesis that detection of events (system integrity and diagnostic related) through Direct Alerts™ via Remote Monitoring allow clinicians… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- The Patient Meets ACC/AHA/ESC Guidelines for Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) Device
- What is being tested?
- Implantation of an ICD/CRT-D device and Merlin.NET PCN
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2010to Apr 2014
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient meets ACC/AHA/ESC guidelines for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT-D) device
- The patient is recently (≤2 weeks) implanted with a SJM device compatible with the Merlin.net™ PCN - (inclusive of upgrade from ICD to CRT-D or an implantable pulse generator change)
- The patient has a life expectancy of greater than 12 months (based on the physician's discretion).
- The patient is mentally capable to participate in the investigation (based on the physician's discretion).
- The patient is 18 years of age or older
Who cannot join
- The patient is being actively considered for cardiac transplantation.
- The patient has primary valvular disease that has not been corrected.
- The patient had a myocardial infarction within the last month
- The patient had unstable angina within the last month.
- The patient has had Coronary Artery Bypass Grafting (CABG) within the last month.
- The patient had a Percutaneous Coronary Angioplasty (PTCA) within the last month.
- The patient is pregnant.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: CLINICAL EVALUATION OF REMOTE MONITORING WITH DIRECT ALERTS TO REDUCE TIME FROM EVENT TO CLINICAL DECISION. (REACT Study)
St. Jude Medical developed the Merlin.net™ Patient Care Network (Merlin.net™ PCN) to augment or replace routine scheduled in-clinic visits.
This investigation is designed with the hypothesis that detection of events (system integrity and diagnostic related) through Direct Alerts™ via Remote Monitoring allow clinicians an earlier opportunity to address and resolve events and may therefore improve patient care.
- Being tested
- Implantation of an ICD/CRT-D device, Merlin.NET PCN
- Keywords
- ICD, CRTD, Remote Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of an ICD/CRT-D deviceDevice
Also called The SJM ICD family of devices with the Invisilink feature are the AnalyST™ and /AnalyST Accel™ and Current™/CurrentTM RF/Current AccelTM., The SJM CRT-D family of devices with the Invisilink feature is the Promote™/PromoteTM RF.
The Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) device and leads are not the devices being evaluated in this investigation.
Merlin.NET PCNDevice
Also called Merlin.NET
The Merlin.Net™ PCN is a dedicated computer system that connects physicians to patients outside of the clinic setting by centralizing data from remote transmissions, implant procedures and in-clinic follow-ups into single location with easy export to Electronic Health Record (EHR) systems
| Study group | Role | What they receive |
|---|---|---|
| Direct Alerts ON | Experimental | Direct Alerts in implantable device were turned on Receives: Device: Implantation of an ICD/CRT-D device; Device: Merlin.NET PCN |
| Direct Alerts OFF | Active comparator | Direct Alerts in implantable device were turned off Receives: Device: Implantation of an ICD/CRT-D device; Device: Merlin.NET PCN |
What is being measured
The primary outcome is the main question the study is designed to answer.
time between the detection of an event and the point in time when the physician or delegate takes a clinical decision
Measured: 2 years
Secondary outcomes (3)
The sufficiency of the device data retrieved through the Remote Monitoring feature to make a clinical decision
Measured: 2 years
The physician or delegate time required for remote follow up as compared to in-clinic follow up
Measured: 2 years
The changes over one year in the Hospital Anxiety and Depression Scale (HADS) for the two different randomization arms
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2012
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Patient Meets ACC/AHA/ESC Guidelines for Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) DeviceStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janet McComb, MD, Principal investigator, Freeman Hospital Newcastle; UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090349
- Sponsor's protocol ID
- CR-09-064-WW-RC
- Acronym
- REACT
- Status last verified
- Feb 2019
- First submitted
- 18 Mar 2010
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLINICAL EVALUATION OF REMOTE MONITORING WITH DIRECT ALERTS TO REDUCE TIME FROM EVENT TO CLINICAL DECISION. (REACT Study)
- ClinicalTrials.gov ID
- NCT01090349
- Acronym / sponsor ID
- REACT / CR-09-064-WW-RC
- Keywords
- ICD, CRTD, Remote Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 19 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
St. Jude Medical developed the Merlin.net™ Patient Care Network (Merlin.net™ PCN) to augment or replace routine scheduled in-clinic visits.
This investigation is designed with the hypothesis that detection of events (system integrity and diagnostic related) through Direct Alerts™ via Remote Monitoring allow clinicians an earlier opportunity to address and resolve events and may therefore improve patient care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct Alerts ON | Experimental | Device: Implantation of an ICD/CRT-D device, Device: Merlin.NET PCNDirect Alerts in implantable device were turned on |
| Direct Alerts OFF | Active comparator | Device: Implantation of an ICD/CRT-D device, Device: Merlin.NET PCNDirect Alerts in implantable device were turned off |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient meets ACC/AHA/ESC guidelines for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT-D) device
- The patient is recently (≤2 weeks) implanted with a SJM device compatible with the Merlin.net™ PCN - (inclusive of upgrade from ICD to CRT-D or an implantable pulse generator change)
- The patient has a life expectancy of greater than 12 months (based on the physician's discretion).
- The patient is mentally capable to participate in the investigation (based on the physician's discretion).
- The patient is 18 years of age or older
Key exclusion criteria (7 listed)
- The patient is being actively considered for cardiac transplantation.
- The patient has primary valvular disease that has not been corrected.
- The patient had a myocardial infarction within the last month
- The patient had unstable angina within the last month.
- The patient has had Coronary Artery Bypass Grafting (CABG) within the last month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of an ICD/CRT-D deviceAlso: The SJM ICD family of devices with the Invisilink feature are the AnalyST™ and /AnalyST Accel™ and Current™/CurrentTM RF/Current AccelTM., The SJM CRT-D family of devices with the Invisilink feature is the Promote™/PromoteTM RF.The Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) device and leads are not the devices being evaluated in this investigation. | Device | Direct Alerts OFF, Direct Alerts ON |
| Merlin.NET PCNAlso: Merlin.NETThe Merlin.Net™ PCN is a dedicated computer system that connects physicians to patients outside of the clinic setting by centralizing data from remote transmissions, implant procedures and in-clinic follow-ups into single location with easy export to Electronic Health Record (EHR) systems | Device | Direct Alerts OFF, Direct Alerts ON |
Primary outcome
time between the detection of an event and the point in time when the physician or delegate takes a clinical decision
Time frame: 2 years
3 secondary outcomes
The sufficiency of the device data retrieved through the Remote Monitoring feature to make a clinical decision
Time frame: 2 years
The physician or delegate time required for remote follow up as compared to in-clinic follow up
Time frame: 2 years
The changes over one year in the Hospital Anxiety and Depression Scale (HADS) for the two different randomization arms
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet McComb, MD principal investigator
Freeman Hospital Newcastle; UK
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of an ICD/CRT-D device and Merlin.NET PCN in people with The Patient Meets ACC/AHA/ESC Guidelines for Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) Device, run by Abbott Medical Devices at 2 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 5 inclusion and 7 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, United Kingdom. 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.
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?
time between the detection of an event and the point in time when the physician or delegate takes a clinical decision (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2019; AzTrials last refreshed its copy on 8 Nov 2026.