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Trial record 1 of 5 for:    Monitoring Resynchronization Devices and Cardiac Patients
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MOnitoring REsynchronization deviCes and cARdiac patiEnts (MORE-CARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00885677
Recruitment Status : Terminated (Low enrollment rate)
First Posted : April 22, 2009
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Heart Failure
Intervention Device: Medtronic CareLink® Network
Enrollment 918
Recruitment Details 918 patients have been enrolled in the study, from 29/05/2009 (date of first enrollment) until 20/08/2014 (date of last enrollment).
Pre-assignment Details 918 subjects signed the Informed Consent Form. One of those subjects withdraw from the study prior randomization, therefore 917 subjects were randomized either to Study (462) or to Control (455) groups.
Arm/Group Title Study Group Control Group
Hide Arm/Group Description

Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity.

Medtronic CareLink® Network: Continuous monitoring via a disease remote management system.

Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur.

Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.
Period Title: Overall Study
Started 462 455
Intention To Treat 437 428
Completed 279 277
Not Completed 183 178
Reason Not Completed
Death             40             34
Lost to Follow-up             15             13
Protocol Violation             54             54
premature study closure             41             44
device/lead revision or replacement             7             6
Heart transplantation             1             0
Inclusion/exclusion not met             25             27
Arm/Group Title Study Group Control Group Total
Hide Arm/Group Description

Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity.

Medtronic CareLink® Network: Continuous monitoring via a disease remote management system.

Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur.

Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits. Total of all reporting groups
Overall Number of Baseline Participants 437 428 865
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 437 participants 428 participants 865 participants
66  (11) 67  (10) 66  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 437 participants 428 participants 865 participants
Female
95
  21.7%
116
  27.1%
211
  24.4%
Male
342
  78.3%
312
  72.9%
654
  75.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 437 participants 428 participants 865 participants
Greece 21 19 40
Netherlands 4 5 9
Hungary 6 6 12
Italy 225 231 456
Israel 3 3 6
Slovakia 12 11 23
France 85 77 162
Switzerland 35 33 68
Spain 46 43 89
History of AF  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 437 participants 428 participants 865 participants
History of AF 89 62 151
No History of AF 340 361 701
Missing 8 5 13
History of Myocardial Infarction  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 437 participants 428 participants 865 participants
With History of Myocardial Infarction 164 173 337
Without History of Myocardial Infarction 262 252 514
Missing 11 3 14
LVEF  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 437 participants 428 participants 865 participants
27.3  (6.6) 27.4  (6.0) 27.3  (6.3)
1.Primary Outcome
Title Phase 1: Median Time Between Event Onset Time and Clinical Decision for Each Subject.
Hide Description The median delay from device-detected events to clinical decisions was considerably shorter in the Remote group compared to the Control group
Time Frame 1 year since the randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Phase 1: A total of 154 patients were enrolled from May 2009 through April 2010 from 32 centers in 6 different countries (France, Hungary, Israel, Italy, Spain, and Switzerland). The final patient cohort object of analysis comprised 148 patients (76 in the Remote group and 72 in the Control group)
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:

Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity.

Medtronic CareLink® Network: Continuous monitoring via a disease remote management system.

Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur.

Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.
Overall Number of Participants Analyzed 76 72
Median (Inter-Quartile Range)
Unit of Measure: days
2
(1 to 4)
29
(3 to 51)
2.Primary Outcome
Title Phase 2: Combined Endpoint of Death From Any Cause, Cardiovascular and Device-related Hospitalizations (at Least 48 Hours Stay), Calculated as Number of Subjects With at Least One Event
Hide Description Time to first event
Time Frame 2 years after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects in analysis were included in the primary endpoint analysis
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:

Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity.

Medtronic CareLink® Network: Continuous monitoring via a disease remote management system.

Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur.

Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.
Overall Number of Participants Analyzed 437 428
Measure Type: Number
Unit of Measure: participants
134 126
Time Frame Adverse events have been collected since subject enrollment until subjct exit/death.
Adverse Event Reporting Description

The following Serious Adverse Events and Adverse Device Effects needed to be reported to Medtronic:

  • Serious Adverse Events (SAE);
  • Serious Adverse Device Effects (SADE);
  • Serious Adverse Procedure related Events (SAPE);
  • Unexpected Serious Adverse Effects (USAE). (Definition ISO EN ISO 14155-1)
 
Arm/Group Title Study Group Control Group
Hide Arm/Group Description

Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity.

Medtronic CareLink® Network: Continuous monitoring via a disease remote management system.

Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur.

Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.
All-Cause Mortality
Study Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Study Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   184/462 (39.83%)      168/455 (36.92%)    
Blood and lymphatic system disorders     
Anaemias nonhaemolytic and marrow depression * 1  3/462 (0.65%)  6 2/455 (0.44%)  2
Cardiac disorders     
Arteriosclerosis, stenosis, vascular insufficiency and necrosis * 1  10/462 (2.16%)  12 11/455 (2.42%)  11
Cardiac arrhythmias * 1  16/462 (3.46%)  22 19/455 (4.18%)  21
Cardiac disorder signs and symptoms * 1  16/462 (3.46%)  16 12/455 (2.64%)  14
Cardiac valve disorders * 1  2/462 (0.43%)  2 3/455 (0.66%)  3
Coronary artery disorders * 1  1/462 (0.22%)  1 4/455 (0.88%)  4
Heart failures * 1  76/462 (16.45%)  132 73/455 (16.04%)  133
Myocardial disorders * 1  0/462 (0.00%)  0 1/455 (0.22%)  1
Surgical and medical procedures * 1  1/462 (0.22%)  1 2/455 (0.44%)  2
Vascular disorders * 1  1/462 (0.22%)  1 0/455 (0.00%)  0
Endocrine disorders     
Thyroid disorder * 1  1/462 (0.22%)  2 3/455 (0.66%)  3
Eye disorders     
Anterior eye structural change, deposit and degeneration * 1  2/462 (0.43%)  3 1/455 (0.22%)  1
Gastrointestinal disorders     
Abdominal hernias and other abdominal wall conditions * 1  1/462 (0.22%)  1 4/455 (0.88%)  4
Gastrointestinal haemorrhages NEC * 1  1/462 (0.22%)  2 1/455 (0.22%)  1
Gastrointestinal infection * 1  0/462 (0.00%)  0 1/455 (0.22%)  1
Gastrointestinal inflammatory conditions * 1  0/462 (0.00%)  0 1/455 (0.22%)  2
Gastrointestinal motility and defaecation conditions * 1  2/462 (0.43%)  2 1/455 (0.22%)  1
Gastrointestinal signs and symptoms * 1  1/462 (0.22%)  1 3/455 (0.66%)  3
General disorders     
Fatal outcome * 1  21/462 (4.55%)  21 20/455 (4.40%)  20
General system disorders NEC * 1  7/462 (1.52%)  7 8/455 (1.76%)  9
Tissue disorder * 1  1/462 (0.22%)  1 0/455 (0.00%)  0
Tissue disorders NEC * 1  0/462 (0.00%)  0 1/455 (0.22%)  2
Hepatobiliary disorders     
Gallbladder disorders * 1  2/462 (0.43%)  2 0/455 (0.00%)  0
Infections and infestations     
Infections - pathogen unspecified * 1  2/462 (0.43%)  2 2/455 (0.44%)  2
Infections and infestations * 1  4/462 (0.87%)  4 4/455 (0.88%)  4
Injury, poisoning and procedural complications     
Bone and joint injuries * 1  5/462 (1.08%)  5 3/455 (0.66%)  3
Cardiac disorder signs and symptoms * 1  0/462 (0.00%)  0 1/455 (0.22%)  1
Injuries NEC * 1  1/462 (0.22%)  1 2/455 (0.44%)  2
Medication errors * 1  1/462 (0.22%)  1 0/455 (0.00%)  0
Procedural and device related injuries and complications NEC * 1  32/462 (6.93%)  33 26/455 (5.71%)  28
Investigations     
Cardiac and vascular investigations (excl enzyme tests) * 1  2/462 (0.43%)  2 1/455 (0.22%)  1
Gastrointestinal investigations * 1  1/462 (0.22%)  1 0/455 (0.00%)  0
Metabolism and nutrition disorders     
Diabetic complications * 1  3/462 (0.65%)  4 2/455 (0.44%)  2
Metabolism disorder * 1  1/462 (0.22%)  1 1/455 (0.22%)  1
Musculoskeletal and connective tissue disorders     
Musculoskeletal and connective tissue disorders NEC * 1  7/462 (1.52%)  9 2/455 (0.44%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor * 1  6/462 (1.30%)  8 8/455 (1.76%)  9
Nervous system disorders     
Central nervous system vascular disorders * 1  3/462 (0.65%)  3 4/455 (0.88%)  4
Headaches * 1  1/462 (0.22%)  1 0/455 (0.00%)  0
Increased intracranial pressure and hydrocephalus * 1  1/462 (0.22%)  1 1/455 (0.22%)  2
Neurological disorders NEC * 1  5/462 (1.08%)  5 0/455 (0.00%)  0
Renal disorders (excl nephropathies) * 1  1/462 (0.22%)  1 0/455 (0.00%)  0
Sleep disturbances (incl subtypes) * 1  0/462 (0.00%)  0 2/455 (0.44%)  2
Psychiatric disorders     
Psychiatric disorders NEC * 1  2/462 (0.43%)  2 1/455 (0.22%)  1
Renal and urinary disorders     
Renal disorder * 1  15/462 (3.25%)  16 7/455 (1.54%)  7
Ureteric disorders * 1  3/462 (0.65%)  3 3/455 (0.66%)  3
Respiratory, thoracic and mediastinal disorders     
Pleural disorders * 1  1/462 (0.22%)  1 1/455 (0.22%)  1
Respiratory disorders NEC * 1  2/462 (0.43%)  2 0/455 (0.00%)  0
Respiratory tract infections * 1  2/462 (0.43%)  2 1/455 (0.22%)  1
Skin and subcutaneous tissue disorders     
Epidermal and dermal conditions * 1  3/462 (0.65%)  3 2/455 (0.44%)  2
Skin and subcutaneous tissue disorders NEC * 1  0/462 (0.00%)  0 1/455 (0.22%)  1
Surgical and medical procedures     
Bone and joint therapeutic procedures * 1  2/462 (0.43%)  3 0/455 (0.00%)  0
Cardiac therapeutic procedures * 1  7/462 (1.52%)  7 10/455 (2.20%)  10
Head and neck therapeutic procedures * 1  1/462 (0.22%)  1 0/455 (0.00%)  0
Renal and urinary tract therapeutic procedures * 1  1/462 (0.22%)  2 0/455 (0.00%)  0
Vascular therapeutic procedures * 1  1/462 (0.22%)  1 1/455 (0.22%)  1
Vascular disorders     
Aneurysms and artery dissections * 1  4/462 (0.87%)  4 1/455 (0.22%)  1
Arteriosclerosis, stenosis, vascular insufficiency and necrosis * 1  6/462 (1.30%)  6 3/455 (0.66%)  3
Vascular disorders NEC * 1  4/462 (0.87%)  4 4/455 (0.88%)  4
Vascular haemorrhagic disorders * 1  4/462 (0.87%)  5 0/455 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Study Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   68/462 (14.72%)      85/455 (18.68%)    
Blood and lymphatic system disorders     
Anaemias nonhaemolytic and marrow depression * 1  2/462 (0.43%)  2 0/455 (0.00%)  0
Cardiac disorders     
Arteriosclerosis, stenosis, vascular insufficiency and necrosis * 1  6/462 (1.30%)  6 8/455 (1.76%)  8
Cardiac arrhythmias * 1  10/462 (2.16%)  12 10/455 (2.20%)  10
Cardiac disorder signs and symptoms * 1  6/462 (1.30%)  6 4/455 (0.88%)  4
Coronary artery disorders * 1  0/462 (0.00%)  0 2/455 (0.44%)  2
Heart failures * 1  10/462 (2.16%)  17 19/455 (4.18%)  27
Myocardial disorders * 1  0/462 (0.00%)  0 1/455 (0.22%)  1
Ear and labyrinth disorders     
Hearing disorders * 1  1/462 (0.22%)  1 0/455 (0.00%)  0
Endocrine disorders     
Thyroid disorder * 1  1/462 (0.22%)  1 1/455 (0.22%)  1
Eye disorders     
Anterior eye structural change, deposit and degeneration * 1  2/462 (0.43%)  3 0/455 (0.00%)  0
Infections - pathogen unspecified * 1  0/462 (0.00%)  0 1/455 (0.22%)  1
Gastrointestinal disorders     
Abdominal hernias and other abdominal wall conditions * 1  1/462 (0.22%)  1 1/455 (0.22%)  1
Gastrointestinal signs and symptoms * 1  0/462 (0.00%)  0 2/455 (0.44%)  2
General disorders     
Device issues * 1  1/462 (0.22%)  1 0/455 (0.00%)  0
General system disorders NEC * 1  1/462 (0.22%)  1 6/455 (1.32%)  7
Infections and infestations     
Infections and infestations * 1  0/462 (0.00%)  0 2/455 (0.44%)  2
Injury, poisoning and procedural complications     
Bone and joint injuries * 1  1/462 (0.22%)  1 0/455 (0.00%)  0
Injuries NEC * 1  2/462 (0.43%)  2 0/455 (0.00%)  0
Procedural and device related injuries and complications NEC * 1  17/462 (3.68%)  17 13/455 (2.86%)  15
Cardiac disorder signs and symptoms * 1  1/462 (0.22%)  1 0/455 (0.00%)  0
Investigations     
Cardiac and vascular investigations (excl enzyme tests) * 1  2/462 (0.43%)  2 3/455 (0.66%)  3
Gastrointestinal investigations * 1  0/462 (0.00%)  0 1/455 (0.22%)  1
Metabolism and nutrition disorders     
Diabetic complications * 1  1/462 (0.22%)  1 1/455 (0.22%)  1
Metabolism disorder * 1  2/462 (0.43%)  2 0/455 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Musculoskeletal and connective tissue disorders NEC * 1  1/462 (0.22%)  2 0/455 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor * 1  1/462 (0.22%)  1 0/455 (0.00%)  0
Nervous system disorders     
Headaches * 1  0/462 (0.00%)  0 1/455 (0.22%)  1
Movement disorders (incl parkinsonism) * 1  0/462 (0.00%)  0 2/455 (0.44%)  2
Neurological disorders NEC * 1  3/462 (0.65%)  3 8/455 (1.76%)  9
Sleep disturbances (incl subtypes) * 1  1/462 (0.22%)  1 1/455 (0.22%)  1
Renal and urinary disorders     
Renal disorder * 1  2/462 (0.43%)  2 0/455 (0.00%)  0
Ureteric disorders * 1  1/462 (0.22%)  1 4/455 (0.88%)  4
Respiratory, thoracic and mediastinal disorders     
Respiratory tract infections * 1  5/462 (1.08%)  5 4/455 (0.88%)  5
Skin and subcutaneous tissue disorders     
Epidermal and dermal conditions * 1  0/462 (0.00%)  0 1/455 (0.22%)  1
Surgical and medical procedures     
Cardiac therapeutic procedures * 1  5/462 (1.08%)  5 7/455 (1.54%)  7
Head and neck therapeutic procedures * 1  0/462 (0.00%)  0 1/455 (0.22%)  1
Decreased and nonspecific blood pressure disorders and shock * 1  0/462 (0.00%)  0 2/455 (0.44%)  2
Vascular disorders     
Aneurysms and artery dissections * 1  1/462 (0.22%)  1 2/455 (0.44%)  2
Vascular disorders NEC * 1  0/462 (0.00%)  0 3/455 (0.66%)  3
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Valentina Amori
Organization: Medtronic EMEA RCC
Phone: 3425417863
EMail: valentina.amori@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00885677    
Other Study ID Numbers: MDT-MORE-CARE
First Submitted: April 21, 2009
First Posted: April 22, 2009
Results First Submitted: November 23, 2016
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017