Clinical trial NCT01090349: Clinical Evaluation Of Remote Monitoring With Direct Alerts To Reduce Time From Event To Clinical Decision
Official title: CLINICAL EVALUATION OF REMOTE MONITORING WITH DIRECT ALERTS TO REDUCE TIME FROM EVENT TO CLINICAL DECISION. (REACT Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: The Patient Meets ACC/AHA/ESC Guidelines for Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) Device
Keywords: ICD, CRTD, Remote Care
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2010-03-19
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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 an earlier opportunity to address and resolve events and may therefore improve patient care.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: time between the detection of an event and the point in time when the physician or delegate takes a clinical decision
timeFrame: 2 years
Secondary outcomes:
measure: The sufficiency of the device data retrieved through the Remote Monitoring feature to make a clinical decision
timeFrame: 2 years
measure: The physician or delegate time required for remote follow up as compared to in-clinic follow up
timeFrame: 2 years
measure: The changes over one year in the Hospital Anxiety and Depression Scale (HADS) for the two different randomization arms
timeFrame: 2 years
Other outcomes:
Locations:
city: Ludwigsburg
country: Germany
facility: Dr. Ralph Bosch
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
Study officials:
affiliation: Freeman Hospital Newcastle; UK
name: Janet McComb, MD
role: PRINCIPAL_INVESTIGATOR
References: