Trial Outcomes & Findings for Clinical effecT of Heart Failure Management Via Home Monitoring With a Focus on Atrial Fibrillation (effecT) (NCT NCT00811382)
NCT ID: NCT00811382
Last Updated: 2024-08-29
Results Overview
Clinical composite outcome based on the days lost due to cardiovascluar mortality, cardiovascular hospitalization and inappropriate ICD therapy during an observational period of 12 months.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
163 participants
Primary outcome timeframe
12 months
Results posted on
2024-08-29
Participant Flow
Participant milestones
| Measure |
1: Access to HMSC
Full functionality of the Home Monitoring System for an early optimization of CRT and management of AF with a full access for the treating physician to the HMSC
Home Monitoring (CRT and AF therapy with Home Monitoring feature): CRT and AF therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring
|
2: No Access to HMSC
Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.
Home Monitoring (CRT and AF therapy, without Home Monitoring): CRT and AF therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)
|
|---|---|---|
|
Overall Study
STARTED
|
88
|
75
|
|
Overall Study
COMPLETED
|
88
|
75
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical effecT of Heart Failure Management Via Home Monitoring With a Focus on Atrial Fibrillation (effecT)
Baseline characteristics by cohort
| Measure |
1: Access to HMSC
n=88 Participants
Full functionality of the Home Monitoring System for an early optimization of CRT and management of AF with a full access for the treating physician to the HMSC.
Home Monitoring (CRT and AF therapy with Home Monitoring feature): CRT and AF therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring.
|
2: No Access to HMSC
n=75 Participants
Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.
Home Monitoring (CRT and AF therapy, without Home Monitoring): CRT and AF therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity).
|
Total
n=163 Participants
Total of all reporting groups
|
|---|---|---|---|
|
New York Heart Association functional class (NYHA class)
Class III
|
75 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Age, Continuous
|
68.7 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
67.3 years
STANDARD_DEVIATION 10 • n=7 Participants
|
68.1 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Height,centimeter (cm)
|
172 cm
STANDARD_DEVIATION 9 • n=5 Participants
|
171 cm
STANDARD_DEVIATION 8 • n=7 Participants
|
172 cm
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Weight, kilogram (kg)
|
82 kg
STANDARD_DEVIATION 16 • n=5 Participants
|
81 kg
STANDARD_DEVIATION 15 • n=7 Participants
|
81 kg
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Body Mass Index (BMI)
|
27.6 kg/m^2
STANDARD_DEVIATION 4.4 • n=5 Participants
|
27.6 kg/m^2
STANDARD_DEVIATION 4.4 • n=7 Participants
|
27.6 kg/m^2
STANDARD_DEVIATION 4.4 • n=5 Participants
|
|
New York Heart Association functional class (NYHA class)
Class I
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
New York Heart Association functional class (NYHA class)
Class II
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
New York Heart Association functional class (NYHA class)
Class IV
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Cardiomyopathy
Ischemic
|
49 participants
n=5 Participants
|
40 participants
n=7 Participants
|
89 participants
n=5 Participants
|
|
Cardiomyopathy
Non-ischemic
|
39 participants
n=5 Participants
|
35 participants
n=7 Participants
|
74 participants
n=5 Participants
|
|
Left ventricular ejection fraction (LVEF)
|
27 Percentage %
STANDARD_DEVIATION 7 • n=5 Participants
|
26 Percentage %
STANDARD_DEVIATION 7 • n=7 Participants
|
27 Percentage %
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Left Ventricular End-Systolic Volume (LVESV)
|
135 ml
STANDARD_DEVIATION 58 • n=5 Participants
|
159 ml
STANDARD_DEVIATION 70 • n=7 Participants
|
146 ml
STANDARD_DEVIATION 64 • n=5 Participants
|
|
Left atrial diameter (LAD)
|
49 mm
STANDARD_DEVIATION 10 • n=5 Participants
|
48 mm
STANDARD_DEVIATION 8 • n=7 Participants
|
48 mm
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Mitral regurgitation
Mild
|
38 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Mitral regurgitation
Moderate
|
28 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Mitral regurgitation
Severe
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Mitral regurgitation
No regurgitation
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Mitral regurgitation
not reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
History of VT/VF
Patients with VT/VF
|
22 patients
n=5 Participants
|
15 patients
n=7 Participants
|
37 patients
n=5 Participants
|
|
History of VT/VF
Patients with No VT/VF
|
66 patients
n=5 Participants
|
60 patients
n=7 Participants
|
126 patients
n=5 Participants
|
|
QRS duration
|
158 ms
STANDARD_DEVIATION 24 • n=5 Participants
|
159 ms
STANDARD_DEVIATION 26 • n=7 Participants
|
158 ms
STANDARD_DEVIATION 25 • n=5 Participants
|
|
Heart Rate
|
71 beats/min
STANDARD_DEVIATION 14 • n=5 Participants
|
68 beats/min
STANDARD_DEVIATION 16 • n=7 Participants
|
70 beats/min
STANDARD_DEVIATION 15 • n=5 Participants
|
|
AV (atrioventricular) Block
No relevant finding
|
36 patients
n=5 Participants
|
32 patients
n=7 Participants
|
68 patients
n=5 Participants
|
|
AV (atrioventricular) Block
First Degree
|
23 patients
n=5 Participants
|
17 patients
n=7 Participants
|
40 patients
n=5 Participants
|
|
AV (atrioventricular) Block
Second Degree
|
2 patients
n=5 Participants
|
3 patients
n=7 Participants
|
5 patients
n=5 Participants
|
|
AV (atrioventricular) Block
Third Degree
|
9 patients
n=5 Participants
|
4 patients
n=7 Participants
|
13 patients
n=5 Participants
|
|
AV (atrioventricular) Block
Other
|
18 patients
n=5 Participants
|
19 patients
n=7 Participants
|
37 patients
n=5 Participants
|
|
Rhythm at enrollment
Sinus Rhythm
|
75 patients
n=5 Participants
|
66 patients
n=7 Participants
|
141 patients
n=5 Participants
|
|
Rhythm at enrollment
AF
|
4 patients
n=5 Participants
|
6 patients
n=7 Participants
|
10 patients
n=5 Participants
|
|
Rhythm at enrollment
Other
|
9 patients
n=5 Participants
|
3 patients
n=7 Participants
|
12 patients
n=5 Participants
|
|
Non-CV (cardiovascular) Morbidity at Enrollment
Diabetes mellitus
|
35 patients
n=5 Participants
|
20 patients
n=7 Participants
|
55 patients
n=5 Participants
|
|
Non-CV (cardiovascular) Morbidity at Enrollment
Renal insufficiency
|
15 patients
n=5 Participants
|
10 patients
n=7 Participants
|
25 patients
n=5 Participants
|
|
Non-CV (cardiovascular) Morbidity at Enrollment
COPD
|
18 patients
n=5 Participants
|
13 patients
n=7 Participants
|
31 patients
n=5 Participants
|
|
Non-CV (cardiovascular) Morbidity at Enrollment
Thyroid disease
|
15 patients
n=5 Participants
|
9 patients
n=7 Participants
|
24 patients
n=5 Participants
|
|
Non-CV (cardiovascular) Morbidity at Enrollment
Hepatic disease
|
2 patients
n=5 Participants
|
1 patients
n=7 Participants
|
3 patients
n=5 Participants
|
|
Non-CV (cardiovascular) Morbidity at Enrollment
Mental disorder
|
4 patients
n=5 Participants
|
2 patients
n=7 Participants
|
6 patients
n=5 Participants
|
|
Non-CV (cardiovascular) Morbidity at Enrollment
Other
|
28 patients
n=5 Participants
|
19 patients
n=7 Participants
|
47 patients
n=5 Participants
|
|
History of AF
Paroxysmal
|
60 patients
n=5 Participants
|
47 patients
n=7 Participants
|
107 patients
n=5 Participants
|
|
History of AF
Persistent
|
21 patients
n=5 Participants
|
19 patients
n=7 Participants
|
40 patients
n=5 Participants
|
|
History of AF
no History of AF
|
7 patients
n=5 Participants
|
9 patients
n=7 Participants
|
16 patients
n=5 Participants
|
|
Ventricular Rate during AF
|
104 beats/min
STANDARD_DEVIATION 33 • n=5 Participants
|
100 beats/min
STANDARD_DEVIATION 32 • n=7 Participants
|
102 beats/min
STANDARD_DEVIATION 33 • n=5 Participants
|
|
Days since AF is known
|
1222 days
STANDARD_DEVIATION 2076 • n=5 Participants
|
644 days
STANDARD_DEVIATION 930 • n=7 Participants
|
974 days
STANDARD_DEVIATION 1701 • n=5 Participants
|
|
History of pharmacological cardioversion
successful
|
15 patients
n=5 Participants
|
9 patients
n=7 Participants
|
24 patients
n=5 Participants
|
|
History of pharmacological cardioversion
not successful
|
5 patients
n=5 Participants
|
3 patients
n=7 Participants
|
8 patients
n=5 Participants
|
|
History of pharmacological cardioversion
not tried
|
61 patients
n=5 Participants
|
54 patients
n=7 Participants
|
115 patients
n=5 Participants
|
|
History of pharmacological cardioversion
not reported
|
7 patients
n=5 Participants
|
9 patients
n=7 Participants
|
16 patients
n=5 Participants
|
|
History of electrical cardioversion
successful
|
30 patients
n=5 Participants
|
24 patients
n=7 Participants
|
54 patients
n=5 Participants
|
|
History of electrical cardioversion
not successful
|
1 patients
n=5 Participants
|
0 patients
n=7 Participants
|
1 patients
n=5 Participants
|
|
History of electrical cardioversion
not tried
|
50 patients
n=5 Participants
|
42 patients
n=7 Participants
|
92 patients
n=5 Participants
|
|
History of electrical cardioversion
not reported
|
7 patients
n=5 Participants
|
9 patients
n=7 Participants
|
16 patients
n=5 Participants
|
|
History of atrial ablation
successful ablation
|
0 patients
n=5 Participants
|
0 patients
n=7 Participants
|
0 patients
n=5 Participants
|
|
History of atrial ablation
partly successful
|
3 patients
n=5 Participants
|
3 patients
n=7 Participants
|
6 patients
n=5 Participants
|
|
History of atrial ablation
not successful
|
3 patients
n=5 Participants
|
1 patients
n=7 Participants
|
4 patients
n=5 Participants
|
|
History of atrial ablation
not tried
|
75 patients
n=5 Participants
|
62 patients
n=7 Participants
|
137 patients
n=5 Participants
|
|
History of atrial ablation
not reported
|
7 patients
n=5 Participants
|
9 patients
n=7 Participants
|
16 patients
n=5 Participants
|
|
History AV node ablation
successful
|
0 patients
n=5 Participants
|
1 patients
n=7 Participants
|
1 patients
n=5 Participants
|
|
History AV node ablation
not successful
|
1 patients
n=5 Participants
|
0 patients
n=7 Participants
|
1 patients
n=5 Participants
|
|
History AV node ablation
not tried
|
80 patients
n=5 Participants
|
65 patients
n=7 Participants
|
145 patients
n=5 Participants
|
|
History AV node ablation
not reported
|
7 patients
n=5 Participants
|
9 patients
n=7 Participants
|
16 patients
n=5 Participants
|
|
AF treatment at enrollment
Rate control
|
16 patients
n=5 Participants
|
14 patients
n=7 Participants
|
30 patients
n=5 Participants
|
|
AF treatment at enrollment
Rhythm control
|
47 patients
n=5 Participants
|
37 patients
n=7 Participants
|
84 patients
n=5 Participants
|
|
AF treatment at enrollment
No AF treatment
|
21 patients
n=5 Participants
|
17 patients
n=7 Participants
|
38 patients
n=5 Participants
|
|
AF treatment at enrollment
not reported
|
4 patients
n=5 Participants
|
7 patients
n=7 Participants
|
11 patients
n=5 Participants
|
|
Medication at Enrollment
ACE inhibitor or ARB
|
72 patients
n=5 Participants
|
63 patients
n=7 Participants
|
135 patients
n=5 Participants
|
|
Medication at Enrollment
Amiodarone
|
36 patients
n=5 Participants
|
36 patients
n=7 Participants
|
72 patients
n=5 Participants
|
|
Medication at Enrollment
Beta blocker
|
69 patients
n=5 Participants
|
63 patients
n=7 Participants
|
132 patients
n=5 Participants
|
|
Medication at Enrollment
Calcium channel blocker
|
5 patients
n=5 Participants
|
3 patients
n=7 Participants
|
8 patients
n=5 Participants
|
|
Medication at Enrollment
Digitalis
|
13 patients
n=5 Participants
|
6 patients
n=7 Participants
|
19 patients
n=5 Participants
|
|
Medication at Enrollment
Sotalol
|
5 patients
n=5 Participants
|
2 patients
n=7 Participants
|
7 patients
n=5 Participants
|
|
Medication at Enrollment
Other antiarrhythmic
|
1 patients
n=5 Participants
|
1 patients
n=7 Participants
|
2 patients
n=5 Participants
|
|
Medication at Enrollment
Anticoagulants
|
61 patients
n=5 Participants
|
54 patients
n=7 Participants
|
115 patients
n=5 Participants
|
|
Medication at Enrollment
Antiplatelet
|
39 patients
n=5 Participants
|
25 patients
n=7 Participants
|
64 patients
n=5 Participants
|
|
Medication at Enrollment
Lipid-lowering drug
|
63 patients
n=5 Participants
|
47 patients
n=7 Participants
|
110 patients
n=5 Participants
|
|
Medication at Enrollment
Nitrate
|
7 patients
n=5 Participants
|
4 patients
n=7 Participants
|
11 patients
n=5 Participants
|
|
Medication at Enrollment
Spironolactone
|
42 patients
n=5 Participants
|
28 patients
n=7 Participants
|
70 patients
n=5 Participants
|
|
Medication at Enrollment
Other diuretic
|
72 patients
n=5 Participants
|
63 patients
n=7 Participants
|
135 patients
n=5 Participants
|
|
Medication at Enrollment
Other medication
|
23 patients
n=5 Participants
|
21 patients
n=7 Participants
|
44 patients
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsClinical composite outcome based on the days lost due to cardiovascluar mortality, cardiovascular hospitalization and inappropriate ICD therapy during an observational period of 12 months.
Outcome measures
| Measure |
1: Access to HMSC
n=88 Participants
Full functionality of the Home Monitoring System for an early optimization of CRT and management of AF with a full access for the treating physician to the HMSC
Home Monitoring (CRT and AF therapy with Home Monitoring feature): CRT and AF therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring
|
2: No Access to HMSC
n=75 Participants
Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.
Home Monitoring (CRT and AF therapy, without Home Monitoring): CRT and AF therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)
|
|---|---|---|
|
Days Lost
|
15.1 Days lost per patient
Standard Deviation 52.5
|
16.0 Days lost per patient
Standard Deviation 47.8
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Endpoint was not evaluated because of the insignificant result for the primary hypothesis and early study discontinuation due to low enrollment
Analysis of the fraction of patients with worsened composite clinical score in the two treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Endpoint was not evaluated because of the insignificant result for the primary hypothesis and early study discontinuation due to low enrollment
Analysis of the change in left ventricular end-systolic volume, left atrial diameter, left ventricular EF, and the degree of mitral regurgitation from enrollment to the end of the follow-up in the two treatment arms
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Endpoint was not evaluated because of the insignificant result for the primary hypothesis and early study discontinuation due to low enrollment
The proportion of patients in sinus rhythm or with paroxysmal AF, persistant AF, or permanet AF at the end of the Follow-Up, without statistical evaluation and analysis of AF/AT (atrial tachycardia) burden based on the home monitoring data
Outcome measures
Outcome data not reported
Adverse Events
1: Access to HMSC
Serious events: 45 serious events
Other events: 6 other events
Deaths: 0 deaths
2: No Access to HMSC
Serious events: 41 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1: Access to HMSC
n=88 participants at risk
Full functionality of the Home Monitoring System for an early optimization of cardiac resynchronization therapy and management of atrial fibrillation with a full access for the treating physician to the Home Monitoring Service Center
Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy with Home Monitoring feature): Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring
|
2: No Access to HMSC
n=75 participants at risk
Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.
Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, without Home Monitoring): Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)
|
|---|---|---|
|
Cardiac disorders
Device related SAEs
|
13.6%
12/88 • Number of events 12 • From date of randomization until the date of death from any cause, study withdrawal, or study termination, which ever came first, assessed up to 1 year
The definition of Adverse Event (AE) and/or serious AE (SAE), used to collect AE information, differs not from the clinicaltrials.gov definitions. There is no source vocabulary for adverse event terms for this study. It is not possible to provide specific AE Terms (e.g. arrhythmia) to indicate whether or not events were related to the device. We used a standard AE Form to document the relationship to the medical device and the investigator ticked "device related, maybe or not related".
|
12.0%
9/75 • Number of events 11 • From date of randomization until the date of death from any cause, study withdrawal, or study termination, which ever came first, assessed up to 1 year
The definition of Adverse Event (AE) and/or serious AE (SAE), used to collect AE information, differs not from the clinicaltrials.gov definitions. There is no source vocabulary for adverse event terms for this study. It is not possible to provide specific AE Terms (e.g. arrhythmia) to indicate whether or not events were related to the device. We used a standard AE Form to document the relationship to the medical device and the investigator ticked "device related, maybe or not related".
|
|
Cardiac disorders
maybe device-related SAEs
|
3.4%
3/88 • Number of events 3 • From date of randomization until the date of death from any cause, study withdrawal, or study termination, which ever came first, assessed up to 1 year
The definition of Adverse Event (AE) and/or serious AE (SAE), used to collect AE information, differs not from the clinicaltrials.gov definitions. There is no source vocabulary for adverse event terms for this study. It is not possible to provide specific AE Terms (e.g. arrhythmia) to indicate whether or not events were related to the device. We used a standard AE Form to document the relationship to the medical device and the investigator ticked "device related, maybe or not related".
|
0.00%
0/75 • From date of randomization until the date of death from any cause, study withdrawal, or study termination, which ever came first, assessed up to 1 year
The definition of Adverse Event (AE) and/or serious AE (SAE), used to collect AE information, differs not from the clinicaltrials.gov definitions. There is no source vocabulary for adverse event terms for this study. It is not possible to provide specific AE Terms (e.g. arrhythmia) to indicate whether or not events were related to the device. We used a standard AE Form to document the relationship to the medical device and the investigator ticked "device related, maybe or not related".
|
|
Cardiac disorders
not device-related SAEs
|
44.3%
39/88 • Number of events 73 • From date of randomization until the date of death from any cause, study withdrawal, or study termination, which ever came first, assessed up to 1 year
The definition of Adverse Event (AE) and/or serious AE (SAE), used to collect AE information, differs not from the clinicaltrials.gov definitions. There is no source vocabulary for adverse event terms for this study. It is not possible to provide specific AE Terms (e.g. arrhythmia) to indicate whether or not events were related to the device. We used a standard AE Form to document the relationship to the medical device and the investigator ticked "device related, maybe or not related".
|
48.0%
36/75 • Number of events 65 • From date of randomization until the date of death from any cause, study withdrawal, or study termination, which ever came first, assessed up to 1 year
The definition of Adverse Event (AE) and/or serious AE (SAE), used to collect AE information, differs not from the clinicaltrials.gov definitions. There is no source vocabulary for adverse event terms for this study. It is not possible to provide specific AE Terms (e.g. arrhythmia) to indicate whether or not events were related to the device. We used a standard AE Form to document the relationship to the medical device and the investigator ticked "device related, maybe or not related".
|
Other adverse events
| Measure |
1: Access to HMSC
n=88 participants at risk
Full functionality of the Home Monitoring System for an early optimization of cardiac resynchronization therapy and management of atrial fibrillation with a full access for the treating physician to the Home Monitoring Service Center
Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy with Home Monitoring feature): Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring
|
2: No Access to HMSC
n=75 participants at risk
Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.
Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, without Home Monitoring): Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)
|
|---|---|---|
|
Cardiac disorders
device-related AEs
|
5.7%
5/88 • Number of events 19 • From date of randomization until the date of death from any cause, study withdrawal, or study termination, which ever came first, assessed up to 1 year
The definition of Adverse Event (AE) and/or serious AE (SAE), used to collect AE information, differs not from the clinicaltrials.gov definitions. There is no source vocabulary for adverse event terms for this study. It is not possible to provide specific AE Terms (e.g. arrhythmia) to indicate whether or not events were related to the device. We used a standard AE Form to document the relationship to the medical device and the investigator ticked "device related, maybe or not related".
|
8.0%
6/75 • Number of events 19 • From date of randomization until the date of death from any cause, study withdrawal, or study termination, which ever came first, assessed up to 1 year
The definition of Adverse Event (AE) and/or serious AE (SAE), used to collect AE information, differs not from the clinicaltrials.gov definitions. There is no source vocabulary for adverse event terms for this study. It is not possible to provide specific AE Terms (e.g. arrhythmia) to indicate whether or not events were related to the device. We used a standard AE Form to document the relationship to the medical device and the investigator ticked "device related, maybe or not related".
|
|
Cardiac disorders
maybe device-related AEs
|
1.1%
1/88 • Number of events 4 • From date of randomization until the date of death from any cause, study withdrawal, or study termination, which ever came first, assessed up to 1 year
The definition of Adverse Event (AE) and/or serious AE (SAE), used to collect AE information, differs not from the clinicaltrials.gov definitions. There is no source vocabulary for adverse event terms for this study. It is not possible to provide specific AE Terms (e.g. arrhythmia) to indicate whether or not events were related to the device. We used a standard AE Form to document the relationship to the medical device and the investigator ticked "device related, maybe or not related".
|
2.7%
2/75 • Number of events 4 • From date of randomization until the date of death from any cause, study withdrawal, or study termination, which ever came first, assessed up to 1 year
The definition of Adverse Event (AE) and/or serious AE (SAE), used to collect AE information, differs not from the clinicaltrials.gov definitions. There is no source vocabulary for adverse event terms for this study. It is not possible to provide specific AE Terms (e.g. arrhythmia) to indicate whether or not events were related to the device. We used a standard AE Form to document the relationship to the medical device and the investigator ticked "device related, maybe or not related".
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60