Trial Outcomes & Findings for Clinical Benefits in Optimized Remote HF Patient Management (NCT NCT01482598)
NCT ID: NCT01482598
Last Updated: 2020-11-16
Results Overview
Combined Endpoint: * proportion of patients with HF hospitalization or emergency unit admission with intravenous diuretics, Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes or cardiovascular/cerebrovascular episodes requiring hospitalization at 12 months * proportion of patients with inappropriate Implantable Cardiac Defibrillator (ICD) therapies delivered at 12 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
144 participants
Primary outcome timeframe
12 months follow up
Results posted on
2020-11-16
Participant Flow
5 subjects not randomized. 139 Subjects randomized in 2 arms
Participant milestones
| Measure |
Optimal Remote Care
Patient follow up is performed through remote care, remote alerts on CRT-D device data are transmitted daily to the hospital, remote follow up is scheduled every 6 months, hospital in clinic follow up is scheduled at 12 months after implant.
Remote Care Follow up: Patient device is checked daily through remote transmitter (Merlin@Home) and every 6 month a complete transmission with all device data is performed
|
Optimal Standard Care
Patient standard in clinic visits are performed every 6 months.
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
73
|
|
Overall Study
COMPLETED
|
50
|
51
|
|
Overall Study
NOT COMPLETED
|
16
|
22
|
Reasons for withdrawal
| Measure |
Optimal Remote Care
Patient follow up is performed through remote care, remote alerts on CRT-D device data are transmitted daily to the hospital, remote follow up is scheduled every 6 months, hospital in clinic follow up is scheduled at 12 months after implant.
Remote Care Follow up: Patient device is checked daily through remote transmitter (Merlin@Home) and every 6 month a complete transmission with all device data is performed
|
Optimal Standard Care
Patient standard in clinic visits are performed every 6 months.
|
|---|---|---|
|
Overall Study
Death
|
7
|
10
|
|
Overall Study
Physician Decision
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
Baseline Characteristics
Weight in Remote Care Arm was available only for 65 subjects instead of 66.
Baseline characteristics by cohort
| Measure |
Optimal Remote Care
n=66 Participants
Patient follow up is performed through remote care, remote alerts on Cardiac Resynchronization Therapy - Defibrillator (CRT-D) device data are transmitted daily to the hospital, remote follow up is scheduled every 6 months, hospital in clinic follow up is scheduled at 12 months after implant.
Remote Care Follow up: Patient device is checked daily through remote transmitter (Merlin@Home) and every 6 month a complete transmission with all device data is performed
|
Optimal Standard Care
n=73 Participants
Patient standard in clinic visits are performed every 6 months.
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.9 years
STANDARD_DEVIATION 11.3 • n=66 Participants
|
71.9 years
STANDARD_DEVIATION 10.6 • n=73 Participants
|
71.0 years
STANDARD_DEVIATION 10.9 • n=139 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=66 Participants
|
20 Participants
n=73 Participants
|
37 Participants
n=139 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=66 Participants
|
53 Participants
n=73 Participants
|
102 Participants
n=139 Participants
|
|
Weight (kg)
|
76.1 Kg
STANDARD_DEVIATION 15.5 • n=65 Participants • Weight in Remote Care Arm was available only for 65 subjects instead of 66.
|
74.4 Kg
STANDARD_DEVIATION 14.3 • n=73 Participants • Weight in Remote Care Arm was available only for 65 subjects instead of 66.
|
75.2 Kg
STANDARD_DEVIATION 14.8 • n=138 Participants • Weight in Remote Care Arm was available only for 65 subjects instead of 66.
|
|
Height (cm)
|
169.0 cm
STANDARD_DEVIATION 7.8 • n=64 Participants • info not available for the entire population
|
168.5 cm
STANDARD_DEVIATION 8.0 • n=71 Participants • info not available for the entire population
|
168.7 cm
STANDARD_DEVIATION 7.9 • n=135 Participants • info not available for the entire population
|
|
NYHA Class
NYHA Class I
|
5 participants
n=66 Participants
|
4 participants
n=73 Participants
|
9 participants
n=139 Participants
|
|
NYHA Class
NYHA Class II
|
24 participants
n=66 Participants
|
27 participants
n=73 Participants
|
51 participants
n=139 Participants
|
|
NYHA Class
NYHA Class III
|
35 participants
n=66 Participants
|
41 participants
n=73 Participants
|
76 participants
n=139 Participants
|
|
NYHA Class
NYHA Class IV
|
2 participants
n=66 Participants
|
1 participants
n=73 Participants
|
3 participants
n=139 Participants
|
|
Widest Intrinsic Complex (QRS) duration (msec)
|
155.9 msec
STANDARD_DEVIATION 23.5 • n=62 Participants • Data not available for the entire study population
|
152.5 msec
STANDARD_DEVIATION 22.9 • n=72 Participants • Data not available for the entire study population
|
154.0 msec
STANDARD_DEVIATION 23.2 • n=134 Participants • Data not available for the entire study population
|
|
Current Medication
Beta Blockers
|
53 Participants
n=66 Participants
|
60 Participants
n=73 Participants
|
113 Participants
n=139 Participants
|
|
Current Medication
Angiotensin-Converting Enzyme (ACE) Inhibitors
|
40 Participants
n=66 Participants
|
49 Participants
n=73 Participants
|
89 Participants
n=139 Participants
|
|
Current Medication
Diuretics
|
63 Participants
n=66 Participants
|
66 Participants
n=73 Participants
|
129 Participants
n=139 Participants
|
|
Current Medication
Aldosterone Antagonist
|
23 Participants
n=66 Participants
|
24 Participants
n=73 Participants
|
47 Participants
n=139 Participants
|
|
Current Medication
Angiotensin Receptor Blockers (ARBs)
|
13 Participants
n=66 Participants
|
16 Participants
n=73 Participants
|
29 Participants
n=139 Participants
|
|
Current Medication
Amiodarone
|
12 Participants
n=66 Participants
|
15 Participants
n=73 Participants
|
27 Participants
n=139 Participants
|
|
Current Medication
Other Antiarrhythmics
|
1 Participants
n=66 Participants
|
3 Participants
n=73 Participants
|
4 Participants
n=139 Participants
|
|
Current Medication
Statins
|
35 Participants
n=66 Participants
|
32 Participants
n=73 Participants
|
67 Participants
n=139 Participants
|
|
Current Medication
Cardiac Glycosides
|
6 Participants
n=66 Participants
|
3 Participants
n=73 Participants
|
9 Participants
n=139 Participants
|
|
Current Medication
Other
|
57 Participants
n=66 Participants
|
64 Participants
n=73 Participants
|
121 Participants
n=139 Participants
|
|
Etiology of cardiovascular disease (Ischemic/Non Ischemic)
Ischemic
|
31 Participants
n=66 Participants
|
27 Participants
n=73 Participants
|
58 Participants
n=139 Participants
|
|
Etiology of cardiovascular disease (Ischemic/Non Ischemic)
Non Ischemic
|
35 Participants
n=66 Participants
|
44 Participants
n=73 Participants
|
79 Participants
n=139 Participants
|
|
Comorbidities
None
|
2 Participants
n=66 Participants
|
7 Participants
n=73 Participants
|
9 Participants
n=139 Participants
|
|
Comorbidities
Paroxysmal AT/AF
|
6 Participants
n=66 Participants
|
10 Participants
n=73 Participants
|
16 Participants
n=139 Participants
|
|
Comorbidities
Hypertension
|
38 Participants
n=66 Participants
|
38 Participants
n=73 Participants
|
76 Participants
n=139 Participants
|
|
Comorbidities
Hypercholesterolemia
|
26 Participants
n=66 Participants
|
16 Participants
n=73 Participants
|
42 Participants
n=139 Participants
|
|
Comorbidities
Diabetes Mellitus
|
14 Participants
n=66 Participants
|
19 Participants
n=73 Participants
|
33 Participants
n=139 Participants
|
|
Comorbidities
Chronic Obstructive Pulmonary Disease
|
8 Participants
n=66 Participants
|
13 Participants
n=73 Participants
|
21 Participants
n=139 Participants
|
|
Comorbidities
Chronic Renal Insufficiency
|
8 Participants
n=66 Participants
|
9 Participants
n=73 Participants
|
17 Participants
n=139 Participants
|
|
Comorbidities
Dysthyroidism
|
5 Participants
n=66 Participants
|
5 Participants
n=73 Participants
|
10 Participants
n=139 Participants
|
|
Comorbidities
Smoking
|
32 Participants
n=66 Participants
|
29 Participants
n=73 Participants
|
61 Participants
n=139 Participants
|
|
Comorbidities
Other
|
14 Participants
n=66 Participants
|
24 Participants
n=73 Participants
|
38 Participants
n=139 Participants
|
|
Implant Information
Implantation Indication (Primary Prevention)
|
60 Participants
n=66 Participants
|
65 Participants
n=73 Participants
|
125 Participants
n=139 Participants
|
|
Implant Information
Implantation Indication (Secondary Prevention)
|
6 Participants
n=66 Participants
|
8 Participants
n=73 Participants
|
14 Participants
n=139 Participants
|
|
Implant Information
Pulse Generator (CRT-D) Position (Left)
|
64 Participants
n=66 Participants
|
72 Participants
n=73 Participants
|
136 Participants
n=139 Participants
|
|
Implant Information
Pulse Generator (CRT-D) Position (Right)
|
2 Participants
n=66 Participants
|
1 Participants
n=73 Participants
|
3 Participants
n=139 Participants
|
|
Implant Information
RA Lead Position (Atrial Appendage)
|
65 Participants
n=66 Participants
|
69 Participants
n=73 Participants
|
134 Participants
n=139 Participants
|
|
Implant Information
RA Lead Position (Atrial Septum)
|
0 Participants
n=66 Participants
|
3 Participants
n=73 Participants
|
3 Participants
n=139 Participants
|
|
Implant Information
RA Lead Position (Atrial Freewall)
|
1 Participants
n=66 Participants
|
0 Participants
n=73 Participants
|
1 Participants
n=139 Participants
|
|
Implant Information
RA Lead Position (Other)
|
0 Participants
n=66 Participants
|
1 Participants
n=73 Participants
|
1 Participants
n=139 Participants
|
|
Implant Information
RV Lead Position (RV Apex)
|
38 Participants
n=66 Participants
|
41 Participants
n=73 Participants
|
79 Participants
n=139 Participants
|
|
Implant Information
RV Lead Position (RV Septum)
|
25 Participants
n=66 Participants
|
31 Participants
n=73 Participants
|
56 Participants
n=139 Participants
|
|
Implant Information
RV Lead Position (RV Outflow)
|
2 Participants
n=66 Participants
|
1 Participants
n=73 Participants
|
3 Participants
n=139 Participants
|
|
Implant Information
RV Lead Position (Other)
|
1 Participants
n=66 Participants
|
0 Participants
n=73 Participants
|
1 Participants
n=139 Participants
|
|
Implant Information
Left Ventricle (LV) Lead Tip Position (Basal Anterior)
|
2 Participants
n=66 Participants
|
0 Participants
n=73 Participants
|
2 Participants
n=139 Participants
|
|
Implant Information
LV Lead Tip Position (Basal Lateral)
|
7 Participants
n=66 Participants
|
11 Participants
n=73 Participants
|
18 Participants
n=139 Participants
|
|
Implant Information
LV Lead Tip Position (Basal Posterior)
|
7 Participants
n=66 Participants
|
2 Participants
n=73 Participants
|
9 Participants
n=139 Participants
|
|
Implant Information
LV Lead Tip Position (Basal Inferior)
|
0 Participants
n=66 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=139 Participants
|
|
Implant Information
LV Lead Tip Position (Basal Post. Septum)
|
0 Participants
n=66 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=139 Participants
|
|
Implant Information
LV Lead Tip Position (Basal Ant. Septum)
|
0 Participants
n=66 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=139 Participants
|
|
Implant Information
LV Lead Tip Position (Medium Anterior)
|
1 Participants
n=66 Participants
|
0 Participants
n=73 Participants
|
1 Participants
n=139 Participants
|
|
Implant Information
LV Lead Tip Position (Medium Lateral)
|
35 Participants
n=66 Participants
|
46 Participants
n=73 Participants
|
81 Participants
n=139 Participants
|
|
Implant Information
LV Lead Tip Position (Medium Posterior)
|
13 Participants
n=66 Participants
|
14 Participants
n=73 Participants
|
27 Participants
n=139 Participants
|
|
Implant Information
LV Lead Tip Position (Medium Inferior)
|
0 Participants
n=66 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=139 Participants
|
|
Implant Information
LV Lead Tip Position (Medium Post Septum)
|
1 Participants
n=66 Participants
|
0 Participants
n=73 Participants
|
1 Participants
n=139 Participants
|
|
Implant Information
LV Lead Tip Position (Medium Ant Septum)
|
0 Participants
n=66 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=139 Participants
|
|
Implant Information
Final Programmed LV Configuration (Distal 1 - Mid 2)
|
26 Participants
n=66 Participants
|
29 Participants
n=73 Participants
|
55 Participants
n=139 Participants
|
|
Implant Information
Final Programmed LV Configuration (Distal 1 - Prox 4)
|
2 Participants
n=66 Participants
|
5 Participants
n=73 Participants
|
7 Participants
n=139 Participants
|
|
Implant Information
Final Programmed LV Configuration (Distal 1 - RV Coil)
|
7 Participants
n=66 Participants
|
11 Participants
n=73 Participants
|
18 Participants
n=139 Participants
|
|
Implant Information
Final Programmed LV Configuration (Mid 2 - Prox 4)
|
3 Participants
n=66 Participants
|
3 Participants
n=73 Participants
|
6 Participants
n=139 Participants
|
|
Implant Information
Final Programmed LV Configuration (Mid 2 - RV Coil)
|
6 Participants
n=66 Participants
|
9 Participants
n=73 Participants
|
15 Participants
n=139 Participants
|
|
Implant Information
Final Programmed LV Configuration (Mid 3 - Mid 2)
|
6 Participants
n=66 Participants
|
3 Participants
n=73 Participants
|
9 Participants
n=139 Participants
|
|
Implant Information
Final Programmed LV Configuration (Mid 3 - Prox 4)
|
7 Participants
n=66 Participants
|
3 Participants
n=73 Participants
|
10 Participants
n=139 Participants
|
|
Implant Information
Final Programmed LV Configuration (Mid 3 - RV Coil))
|
5 Participants
n=66 Participants
|
5 Participants
n=73 Participants
|
10 Participants
n=139 Participants
|
|
Implant Information
Final Programmed LV Configuration (Prox 4 - Mid 2)
|
1 Participants
n=66 Participants
|
1 Participants
n=73 Participants
|
2 Participants
n=139 Participants
|
|
Implant Information
Final Programmed LV Configuration (Prox 4 - RV Coil)
|
3 Participants
n=66 Participants
|
4 Participants
n=73 Participants
|
7 Participants
n=139 Participants
|
|
Implant Information (Electrical Measures)
Capture Threshold (V) at 0.5 ms
|
14 units on a scale
STANDARD_DEVIATION 0.8 • n=66 Participants • Measure Description: data not available for the entire population
|
1.4 units on a scale
STANDARD_DEVIATION 1.1 • n=72 Participants • Measure Description: data not available for the entire population
|
1.4 units on a scale
STANDARD_DEVIATION 1.0 • n=138 Participants • Measure Description: data not available for the entire population
|
|
Implant Information (Electrical Measures)
Phrenic Nerve Stimulation Threshold (V) at 0.5 ms
|
4.6 units on a scale
STANDARD_DEVIATION 1.4 • n=4 Participants • Measure Description: data not available for the entire population
|
4.9 units on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants • Measure Description: data not available for the entire population
|
4.8 units on a scale
STANDARD_DEVIATION 1.4 • n=9 Participants • Measure Description: data not available for the entire population
|
|
Implant Information (Electrical Measures)
|
773.3 Impedance (Ω)
STANDARD_DEVIATION 259.3 • n=66 Participants
|
757.1 Impedance (Ω)
STANDARD_DEVIATION 237.2 • n=73 Participants
|
764.8 Impedance (Ω)
STANDARD_DEVIATION 247.1 • n=139 Participants
|
|
Implant Information (AV/PV & V-V Delay Optimization method)
Echo
|
0 Participants
n=66 Participants
|
4 Participants
n=73 Participants
|
4 Participants
n=139 Participants
|
|
Implant Information (AV/PV & V-V Delay Optimization method)
Echo (Specify parameters)
|
0 Participants
n=66 Participants
|
2 Participants
n=73 Participants
|
2 Participants
n=139 Participants
|
|
Implant Information (AV/PV & V-V Delay Optimization method)
QuickOpt
|
39 Participants
n=66 Participants
|
32 Participants
n=73 Participants
|
71 Participants
n=139 Participants
|
|
Implant Information (AV/PV & V-V Delay Optimization method)
Default Parameters
|
15 Participants
n=66 Participants
|
23 Participants
n=73 Participants
|
38 Participants
n=139 Participants
|
|
Implant Information (AV/PV & V-V Delay Optimization method)
Other
|
12 Participants
n=66 Participants
|
12 Participants
n=73 Participants
|
24 Participants
n=139 Participants
|
|
Implant Information (Device Programming)
Pacing Mode (DDD)
|
66 Participants
n=66 Participants
|
73 Participants
n=73 Participants
|
139 Participants
n=139 Participants
|
|
Implant Information (Device Programming)
Sensor (On)
|
6 Participants
n=66 Participants
|
6 Participants
n=73 Participants
|
12 Participants
n=139 Participants
|
|
Implant Information (Device Programming)
Sensor (Off)
|
60 Participants
n=66 Participants
|
67 Participants
n=73 Participants
|
127 Participants
n=139 Participants
|
|
Implant Information (Device Programming)
AF Suppression (On)
|
0 Participants
n=66 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=139 Participants
|
|
Implant Information (Device Programming)
AF Suppression (Off)
|
66 Participants
n=66 Participants
|
73 Participants
n=73 Participants
|
139 Participants
n=139 Participants
|
|
Implant Information (Base Rate)
|
52.5 bpm
STANDARD_DEVIATION 7.4 • n=66 Participants
|
52.7 bpm
STANDARD_DEVIATION 7.8 • n=73 Participants
|
52.6 bpm
STANDARD_DEVIATION 7.6 • n=139 Participants
|
|
Implant Information (Intervals Programming)
AV Delay (msec)
|
147.4 units on a scale
STANDARD_DEVIATION 24.3 • n=66 Participants • data not available for the entire population
|
146.2 units on a scale
STANDARD_DEVIATION 18.3 • n=73 Participants • data not available for the entire population
|
146.8 units on a scale
STANDARD_DEVIATION 21.3 • n=139 Participants • data not available for the entire population
|
|
Implant Information (Intervals Programming)
PV Delay (msec)
|
112.1 units on a scale
STANDARD_DEVIATION 14.4 • n=66 Participants • data not available for the entire population
|
111.8 units on a scale
STANDARD_DEVIATION 13.3 • n=73 Participants • data not available for the entire population
|
111.9 units on a scale
STANDARD_DEVIATION 13.8 • n=139 Participants • data not available for the entire population
|
|
Implant Information (Intervals Programming)
VV Delay (msec)
|
34.4 units on a scale
STANDARD_DEVIATION 15.2 • n=36 Participants • data not available for the entire population
|
33.7 units on a scale
STANDARD_DEVIATION 15.9 • n=47 Participants • data not available for the entire population
|
34.0 units on a scale
STANDARD_DEVIATION 15.5 • n=83 Participants • data not available for the entire population
|
|
Implant Information (VV Delay and Final LV Pacing Vector Programming)
VV Delay (Simultaneous)
|
30 Participants
n=66 Participants
|
26 Participants
n=73 Participants
|
56 Participants
n=139 Participants
|
|
Implant Information (VV Delay and Final LV Pacing Vector Programming)
VV Delay (LV First)
|
34 Participants
n=66 Participants
|
46 Participants
n=73 Participants
|
80 Participants
n=139 Participants
|
|
Implant Information (VV Delay and Final LV Pacing Vector Programming)
VV Delay (RV First)
|
2 Participants
n=66 Participants
|
1 Participants
n=73 Participants
|
3 Participants
n=139 Participants
|
|
Implant Information (VV Delay and Final LV Pacing Vector Programming)
Final LV Pacing Vector (Distal 1 - Mid 2)
|
26 Participants
n=66 Participants
|
30 Participants
n=73 Participants
|
56 Participants
n=139 Participants
|
|
Implant Information (VV Delay and Final LV Pacing Vector Programming)
Final LV Pacing Vector (Distal 1 - Prox 4)
|
2 Participants
n=66 Participants
|
5 Participants
n=73 Participants
|
7 Participants
n=139 Participants
|
|
Implant Information (VV Delay and Final LV Pacing Vector Programming)
Final LV Pacing Vector (Distal 1 - RV Coil)
|
7 Participants
n=66 Participants
|
11 Participants
n=73 Participants
|
18 Participants
n=139 Participants
|
|
Implant Information (VV Delay and Final LV Pacing Vector Programming)
Final LV Pacing Vector (Mid 2 - Prox 4)
|
3 Participants
n=66 Participants
|
3 Participants
n=73 Participants
|
6 Participants
n=139 Participants
|
|
Implant Information (VV Delay and Final LV Pacing Vector Programming)
Final LV Pacing Vector (Mid 2 - RV Coil)
|
6 Participants
n=66 Participants
|
10 Participants
n=73 Participants
|
16 Participants
n=139 Participants
|
|
Implant Information (VV Delay and Final LV Pacing Vector Programming)
Final LV Pacing Vector (Mid 3 - Mid 2)
|
6 Participants
n=66 Participants
|
3 Participants
n=73 Participants
|
9 Participants
n=139 Participants
|
|
Implant Information (VV Delay and Final LV Pacing Vector Programming)
Final LV Pacing Vector (Mid 3 - Prox 4)
|
7 Participants
n=66 Participants
|
3 Participants
n=73 Participants
|
10 Participants
n=139 Participants
|
|
Implant Information (VV Delay and Final LV Pacing Vector Programming)
Final LV Pacing Vector (Mid 3 - RV Coil)
|
5 Participants
n=66 Participants
|
4 Participants
n=73 Participants
|
9 Participants
n=139 Participants
|
|
Implant Information (VV Delay and Final LV Pacing Vector Programming)
Final LV Pacing Vector (Prox 4 - Mid 2)
|
1 Participants
n=66 Participants
|
0 Participants
n=73 Participants
|
1 Participants
n=139 Participants
|
|
Implant Information (VV Delay and Final LV Pacing Vector Programming)
Final LV Pacing Vector (Prox 4 - RV Coil)
|
3 Participants
n=66 Participants
|
4 Participants
n=73 Participants
|
7 Participants
n=139 Participants
|
|
Implant Information (Patient Notifier and Merlin.net Programming)
Patient Notifier programmed as Protocol · Yes
|
63 Participants
n=66 Participants • data not available for the entire population
|
67 Participants
n=73 Participants • data not available for the entire population
|
130 Participants
n=139 Participants • data not available for the entire population
|
|
Implant Information (Patient Notifier and Merlin.net Programming)
Patient Notifier programmed as Protocol · No
|
3 Participants
n=66 Participants • data not available for the entire population
|
6 Participants
n=73 Participants • data not available for the entire population
|
9 Participants
n=139 Participants • data not available for the entire population
|
|
Implant Information (Patient Notifier and Merlin.net Programming)
Merlin.Net patient profile programmed as Protocol · Yes
|
65 Participants
n=66 Participants • data not available for the entire population
|
5 Participants
n=73 Participants • data not available for the entire population
|
70 Participants
n=139 Participants • data not available for the entire population
|
|
Implant Information (Patient Notifier and Merlin.net Programming)
Merlin.Net patient profile programmed as Protocol · No
|
1 Participants
n=66 Participants • data not available for the entire population
|
68 Participants
n=73 Participants • data not available for the entire population
|
69 Participants
n=139 Participants • data not available for the entire population
|
|
Implant Information (Patient Notifier and Merlin.net Programming)
Direct Alerts programmed as Protocol · Yes
|
65 Participants
n=65 Participants • data not available for the entire population
|
5 Participants
n=5 Participants • data not available for the entire population
|
70 Participants
n=70 Participants • data not available for the entire population
|
|
Implant Information (Patient Notifier and Merlin.net Programming)
Direct Alerts programmed as Protocol · No
|
0 Participants
n=65 Participants • data not available for the entire population
|
0 Participants
n=5 Participants • data not available for the entire population
|
0 Participants
n=70 Participants • data not available for the entire population
|
PRIMARY outcome
Timeframe: 12 months follow upPopulation: The study enrolled less than one third of expected patients as per sample size (144 out of 438). The pool of data collected during the follow up phase were spare and incomplete for the major part of patients enrolled. In addition an high number of deviations were collected during the study due to incomplete data collection. For the aforementioned reasons, the analysis for primary and secondary endpoints hasn't been performed.
Combined Endpoint: * proportion of patients with HF hospitalization or emergency unit admission with intravenous diuretics, Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes or cardiovascular/cerebrovascular episodes requiring hospitalization at 12 months * proportion of patients with inappropriate Implantable Cardiac Defibrillator (ICD) therapies delivered at 12 months
Outcome measures
Outcome data not reported
Adverse Events
Optimal Standard Care
Serious events: 37 serious events
Other events: 13 other events
Deaths: 10 deaths
Remote Care
Serious events: 28 serious events
Other events: 21 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Optimal Standard Care
n=73 participants at risk
Patient standard in clinic visits are performed every 6 months.
|
Remote Care
n=66 participants at risk
Patients perform a 6 and 18 (optional) months Remote Follow Up and 12 and 24 months in clinic visits
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
1.4%
1/73 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
|
Cardiac disorders
Atrial Flutter
|
1.4%
1/73 • Number of events 1
|
0.00%
0/66
|
|
Cardiac disorders
Cardiac Arrest
|
1.4%
1/73 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
1.4%
1/73 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
|
Cardiac disorders
Heart Failure
|
13.7%
10/73 • Number of events 13
|
10.6%
7/66 • Number of events 8
|
|
Cardiac disorders
Pulmonary Edema
|
1.4%
1/73 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
|
Gastrointestinal disorders
Gastric Ulcer
|
1.4%
1/73 • Number of events 1
|
0.00%
0/66
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/73
|
1.5%
1/66 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.00%
0/73
|
1.5%
1/66 • Number of events 1
|
|
General disorders
Cardiac Death
|
1.4%
1/73 • Number of events 1
|
0.00%
0/66
|
|
Infections and infestations
Infected Skin Ulcer
|
0.00%
0/73
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Urosepsis
|
1.4%
1/73 • Number of events 1
|
0.00%
0/66
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
1.4%
1/73 • Number of events 1
|
0.00%
0/66
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
1.4%
1/73 • Number of events 1
|
0.00%
0/66
|
|
Injury, poisoning and procedural complications
Implant Site Infection
|
1.4%
1/73 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
1/73 • Number of events 1
|
0.00%
0/66
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
0.00%
0/73
|
1.5%
1/66 • Number of events 1
|
|
Metabolism and nutrition disorders
Respiratory Failure
|
1.4%
1/73 • Number of events 1
|
3.0%
2/66 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.00%
0/73
|
1.5%
1/66 • Number of events 1
|
|
Nervous system disorders
Carotid Artery Thrombosis
|
0.00%
0/73
|
1.5%
1/66 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colonic Polyp
|
1.4%
1/73 • Number of events 1
|
0.00%
0/66
|
|
Musculoskeletal and connective tissue disorders
Coxarthrosis
|
1.4%
1/73 • Number of events 1
|
0.00%
0/66
|
|
Cardiac disorders
Non ST segment elevation acute coronary syndrome
|
1.4%
1/73 • Number of events 1
|
0.00%
0/66
|
|
General disorders
Hemodynamic Instability
|
0.00%
0/73
|
1.5%
1/66 • Number of events 1
|
|
Cardiac disorders
Sudden Death, Cause Unknown
|
1.4%
1/73 • Number of events 1
|
0.00%
0/66
|
|
General disorders
Unknown Cause of Death
|
1.4%
1/73 • Number of events 1
|
0.00%
0/66
|
|
Injury, poisoning and procedural complications
Pocket Formation of Decubitus
|
1.4%
1/73 • Number of events 2
|
0.00%
0/66
|
|
Injury, poisoning and procedural complications
Medical Device Replacement
|
0.00%
0/73
|
1.5%
1/66 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypernatremia
|
1.4%
1/73 • Number of events 1
|
0.00%
0/66
|
|
Metabolism and nutrition disorders
Renal Venous Congestion
|
1.4%
1/73 • Number of events 1
|
0.00%
0/66
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis of the foot
|
0.00%
0/73
|
1.5%
1/66 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukemia
|
1.4%
1/73 • Number of events 1
|
0.00%
0/66
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Cancer
|
1.4%
1/73 • Number of events 1
|
0.00%
0/66
|
|
Reproductive system and breast disorders
Prostate Cancer Metastatic
|
1.4%
1/73 • Number of events 1
|
0.00%
0/66
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.4%
1/73 • Number of events 1
|
0.00%
0/66
|
|
Surgical and medical procedures
Angioplasty
|
0.00%
0/73
|
1.5%
1/66 • Number of events 1
|
|
Surgical and medical procedures
Aortic Valve Replacement
|
1.4%
1/73 • Number of events 1
|
0.00%
0/66
|
|
Surgical and medical procedures
Foot Amputation
|
0.00%
0/73
|
1.5%
1/66 • Number of events 1
|
|
Surgical and medical procedures
Skin Graft
|
0.00%
0/73
|
1.5%
1/66 • Number of events 1
|
|
Vascular disorders
Cardiogenic Shock
|
0.00%
0/73
|
1.5%
1/66 • Number of events 1
|
|
Product Issues
Lead Dislodgement
|
1.4%
1/73 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
Other adverse events
| Measure |
Optimal Standard Care
n=73 participants at risk
Patient standard in clinic visits are performed every 6 months.
|
Remote Care
n=66 participants at risk
Patients perform a 6 and 18 (optional) months Remote Follow Up and 12 and 24 months in clinic visits
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/73
|
1.5%
1/66 • Number of events 1
|
|
Cardiac disorders
Cardiac Failure
|
1.4%
1/73 • Number of events 1
|
0.00%
0/66
|
|
Cardiac disorders
Chest Pain
|
1.4%
1/73 • Number of events 1
|
0.00%
0/66
|
|
Cardiac disorders
Dyspnea
|
0.00%
0/73
|
1.5%
1/66 • Number of events 1
|
|
Cardiac disorders
Pulmonary Congestion
|
1.4%
1/73 • Number of events 1
|
0.00%
0/66
|
|
Cardiac disorders
Pulmonary Edema
|
0.00%
0/73
|
1.5%
1/66 • Number of events 1
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/73
|
1.5%
1/66 • Number of events 1
|
|
General disorders
Asthenia
|
0.00%
0/73
|
1.5%
1/66 • Number of events 1
|
|
Injury, poisoning and procedural complications
Chest Crushing
|
1.4%
1/73 • Number of events 1
|
0.00%
0/66
|
|
Investigations
Angiogram
|
0.00%
0/73
|
1.5%
1/66 • Number of events 1
|
|
Investigations
Sinus Rhythm
|
1.4%
1/73 • Number of events 1
|
0.00%
0/66
|
|
Product Issues
Device Capturing Issue
|
1.4%
1/73 • Number of events 1
|
6.1%
4/66 • Number of events 4
|
|
Product Issues
Device Electrical Impedance Issue
|
1.4%
1/73 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
|
Product Issues
Device Inappropriate shock delivery
|
2.7%
2/73 • Number of events 2
|
6.1%
4/66 • Number of events 4
|
|
Product Issues
Device Malfunction
|
1.4%
1/73 • Number of events 1
|
3.0%
2/66 • Number of events 2
|
|
Product Issues
Device Telemetry Issue
|
0.00%
0/73
|
3.0%
2/66 • Number of events 2
|
|
Product Issues
Lead Dislodgement
|
1.4%
1/73 • Number of events 1
|
0.00%
0/66
|
|
Product Issues
Mobile Medical Application Issue
|
0.00%
0/73
|
1.5%
1/66 • Number of events 1
|
|
Product Issues
Oversensing
|
1.4%
1/73 • Number of events 1
|
0.00%
0/66
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.4%
1/73 • Number of events 1
|
0.00%
0/66
|
|
Reproductive system and breast disorders
Hematuria
|
0.00%
0/73
|
1.5%
1/66 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place