Trial Outcomes & Findings for Improve SCA Bridge Study (NCT NCT03715790)
NCT ID: NCT03715790
Last Updated: 2024-01-16
Results Overview
The numerator for this endpoint will be defined as the number of patients who met the clinician's determination to refer the subject for SCD risk stratification and management at any of the three follow-up visits. The denominator for this endpoint is the number of patients who completed a 3-month follow-up visit. While the participant study flow is composed of "referred" and "not referred" groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this one arm. No hypotheses were tested for this endpoint.
COMPLETED
1491 participants
3-months post-MI to 12-months post-MI
2024-01-16
Participant Flow
While the study objective was to categorize patients into those who met referral criteria and those who did not, those two groups were not, strictly speaking, considered to be treatment arms. Rather, subjects in the single enrolled patients arm could, by meeting the required criteria at any of the three follow-up evaluations, be reported in the referral group. Thus the two groups were the result of the collective referral assessments and not separate study arms with a subsequent study flow.
Participant milestones
| Measure |
Post-acute MI Patients Who Are Candidates for SCA Risk Stratification
Subjects who were enrolled in the Improve SCA Bridge Study and were not excluded due to not meeting inclusion/exclusion criteria
|
|---|---|
|
3-months
STARTED
|
1491
|
|
3-months
COMPLETED
|
1170
|
|
3-months
NOT COMPLETED
|
321
|
|
6-months
STARTED
|
1170
|
|
6-months
COMPLETED
|
916
|
|
6-months
NOT COMPLETED
|
254
|
|
12-months
STARTED
|
916
|
|
12-months
COMPLETED
|
887
|
|
12-months
NOT COMPLETED
|
29
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Enrolled Subjects
n=1491 Participants
Subjects who were enrolled in the Improve SCA Bridge Study and were not excluded due to not meeting inclusion/exclusion criteria
|
|---|---|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 12 • n=1491 Participants
|
|
Sex: Female, Male
Female
|
263 Participants
n=1491 Participants
|
|
Sex: Female, Male
Male
|
1228 Participants
n=1491 Participants
|
|
Region of Enrollment
Singapore
|
19 participants
n=1491 Participants
|
|
Region of Enrollment
Philippines
|
1 participants
n=1491 Participants
|
|
Region of Enrollment
Egypt
|
15 participants
n=1491 Participants
|
|
Region of Enrollment
Malaysia
|
86 participants
n=1491 Participants
|
|
Region of Enrollment
Thailand
|
22 participants
n=1491 Participants
|
|
Region of Enrollment
India
|
267 participants
n=1491 Participants
|
|
Region of Enrollment
Saudi Arabia
|
70 participants
n=1491 Participants
|
|
Region of Enrollment
Brunei
|
30 participants
n=1491 Participants
|
|
Region of Enrollment
Bangladesh
|
80 participants
n=1491 Participants
|
|
Region of Enrollment
South Korea
|
237 participants
n=1491 Participants
|
|
Region of Enrollment
Pakistan
|
50 participants
n=1491 Participants
|
|
Region of Enrollment
China
|
394 participants
n=1491 Participants
|
|
Region of Enrollment
Taiwan
|
120 participants
n=1491 Participants
|
|
Region of Enrollment
South Africa
|
12 participants
n=1491 Participants
|
|
Region of Enrollment
Tunisia
|
50 participants
n=1491 Participants
|
|
Region of Enrollment
Indonesia
|
38 participants
n=1491 Participants
|
PRIMARY outcome
Timeframe: 3-months post-MI to 12-months post-MIPopulation: Enrolled subjects who were evaluated at 3-month follow up to determine if they met referral criteria or did not meet referral criteria.
The numerator for this endpoint will be defined as the number of patients who met the clinician's determination to refer the subject for SCD risk stratification and management at any of the three follow-up visits. The denominator for this endpoint is the number of patients who completed a 3-month follow-up visit. While the participant study flow is composed of "referred" and "not referred" groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this one arm. No hypotheses were tested for this endpoint.
Outcome measures
| Measure |
Referred Subjects
n=1170 Participants
Subjects who were referred for SCA risk stratification
|
Not Referred Subjects
n=1170 Participants
Subjects who were not referred for SCA risk stratification
|
|---|---|---|
|
Percentage of Post-Acute MI Patients Who Are Referred for Sudden Cardiac Death Risk Stratification > Risk (SCD) Stratification and Management
|
236 Participants
|
934 Participants
|
SECONDARY outcome
Timeframe: 3-months post-MI to 12-months post-MIPopulation: Enrolled subjects who were evaluated at 3-month follow up to determine if they met referral criteria or did not meet referral criteria.
The numerator for this endpoint will be the number of subjects who were indicated for an ICD/CRT-D device during any of the three follow-up visits. The denominator will be the number of subjects who completed a 3-month follow-up visit. While the participant study flow is composed of "referred" and "not referred" groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this single arm. The analysis cannot be performed within the "referred" and "not referred" groups as patients not referred are not eligible for the secondary endpoints involving device indication or implant. No hypotheses were tested for this endpoint.
Outcome measures
| Measure |
Referred Subjects
n=1170 Participants
Subjects who were referred for SCA risk stratification
|
Not Referred Subjects
Subjects who were not referred for SCA risk stratification
|
|---|---|---|
|
Percentage of Post-Acute MI Patients Who Are Known to be Indicated for an ICD/CRT-D Within 12 Months Post-MI
|
127 Participants
|
—
|
SECONDARY outcome
Timeframe: 3-months post-MI to 12-months post-MIPopulation: Enrolled subjects who were evaluated at 3-month follow up to determine if they met referral criteria or did not meet referral criteria.
The numerator for this endpoint will be the number of subjects who received an ICD/CRT-D device during any of the three follow-up visits. The denominator for this endpoint will be the number of patients who completed a 3-month follow-up visit. While the participant study flow is composed of "referred" and "not referred" groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this single arm. The analysis cannot be performed within the "referred" and "not referred" groups as patients not referred are not eligible for the secondary endpoints involving device indication or implant. No hypotheses were tested for this endpoint.
Outcome measures
| Measure |
Referred Subjects
n=1170 Participants
Subjects who were referred for SCA risk stratification
|
Not Referred Subjects
Subjects who were not referred for SCA risk stratification
|
|---|---|---|
|
Percentage of Post-Acute MI Patients Who Receive an ICD/CRT-D Within 12 Months Post-MI.
|
18 Participants
|
—
|
SECONDARY outcome
Timeframe: 3-months post-MI to 12-months post-MIPopulation: Enrolled patients who, at the 3-month visit, met the criteria for referral for SCD risk stratification. These criteria include a reduced ejection fraction less than or equal to 40%, ventricular arrhythmia, AV block, new onset bundle branch block, or conduction abnormalities, or unexplained syncope, clinically significant palpitations or symptomatic bradycardia.
The outcome measure will be the percentage of patients with ICD indication, who were not referred, refused referral or refused implant. The denominator will count all patients with at least one of the below: 1. a reduced ejection fraction, as measured by the Left Ventricular Ejection Fraction (LVEF) being lower or equal than 40%. \> 2. ventricular arrhythmia, AV block, new onset bundle branch block, or conduction abnormalities as measured by ECGs. \> 3. unexplained syncope, clinically significant palpitations or symptomatic bradycardia as assessed by the physician. \> The numerator will count the patients included in the denominator who were not referred, refused referral or refused implant of an ICD/CRT-D. While the participant study flow is composed of "referred" and "not referred" groups, these groups are simply the referral process results in the single arm of enrolled patients, with analysis performed within this arm. No hypotheses were tested for this endpoint.
Outcome measures
| Measure |
Referred Subjects
n=398 Participants
Subjects who were referred for SCA risk stratification
|
Not Referred Subjects
Subjects who were not referred for SCA risk stratification
|
|---|---|---|
|
Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD
Number of patients who who were not referred, refused referral or refused implant of an ICD/CRT-D
|
162 Participants
|
—
|
|
Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD
Number of patients not referred due to "the patient deemed referral not necessary".
|
21 Participants
|
—
|
|
Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD
Number of patients not referred due to "the patient was asymptomatic".
|
42 Participants
|
—
|
|
Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD
Number of patients not referred due to "the physician preferred continuing with medication".
|
75 Participants
|
—
|
|
Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD
Number of patients who refused implant due to "patient does not want risk associated with implant".
|
40 Participants
|
—
|
|
Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD
Number of patients who refused implant due to "patient does not believe in benefit of ICD/CRT-D".
|
36 Participants
|
—
|
|
Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD
Number of patients who refused implant due to "patient unable to pay for device".
|
62 Participants
|
—
|
SECONDARY outcome
Timeframe: Enrollment to 12-months post-MIPopulation: Enrolled subjects
The numerator for this endpoint will be the number of patients who experience cardiovascular mortality. The denominator will be the number of patients enrolled in the study. No hypotheses were tested for this endpoint.
Outcome measures
| Measure |
Referred Subjects
n=1491 Participants
Subjects who were referred for SCA risk stratification
|
Not Referred Subjects
Subjects who were not referred for SCA risk stratification
|
|---|---|---|
|
Percentage of Post-Acute MI Patients Who Experience Cardiovascular Mortality
|
29 Participants
|
—
|
SECONDARY outcome
Timeframe: Enrollment to 3-months post-MIPopulation: Acute LVEF measurements occurred at baseline on 1491 subjects. Chronic LVEF measurements were collected at the 3-month follow up on 1046 subjects (104 subjects were exited before the 3-month follow up, and 341 subjects did not have their LVEF measurement taken at the 3-month follow up).
The Left Ventricular Ejection Fraction (LVEF) will be measured acutely post MI (≤14 days after MI onset) and chronically (40-90 days). The acute measurement will occur over all 1491 subjects assessed at baseline, while the chronic assessment will be measured over the 1046 subjects with a 3-month LVEF assessment. This outcome will compare the average LVEF, by percent, between these two phases. No hypotheses were tested for this endpoint.
Outcome measures
| Measure |
Referred Subjects
n=1491 Participants
Subjects who were referred for SCA risk stratification
|
Not Referred Subjects
Subjects who were not referred for SCA risk stratification
|
|---|---|---|
|
Evolution of the Ejection Fraction Over the Immediate Period of Post MI
Acute
|
39.8 Percentage of LV stroke volume
Standard Deviation 6.8
|
—
|
|
Evolution of the Ejection Fraction Over the Immediate Period of Post MI
Chronic
|
46.3 Percentage of LV stroke volume
Standard Deviation 10.3
|
—
|
Adverse Events
Enrolled Subjects
Serious adverse events
| Measure |
Enrolled Subjects
n=1491 participants at risk
Subjects who were enrolled in the Improve SCA Bridge Study and were not excluded due to not meeting inclusion/exclusion criteria.
While enrolled patients were separated into "Referred" and "Not-Referred" groups based on the outcomes at the 3-month visit, these groups are not separate treatment arms. It would be misleading to compare adverse events between these groups as patients not referred due to an LVEF above 50% were subsequently not followed and had relatively little exposure when compared with the referred patients.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.47%
7/1491 • Number of events 7 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Acute Left Ventricular Failure
|
0.34%
5/1491 • Number of events 5 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
1.6%
24/1491 • Number of events 26 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Angina Pectoris
|
0.47%
7/1491 • Number of events 8 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Angina Unstable
|
0.27%
4/1491 • Number of events 4 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Arrhythmia
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Arteriosclerosis Coronary Artery
|
0.34%
5/1491 • Number of events 5 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Bradycardia
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Cardiac Arrest
|
0.47%
7/1491 • Number of events 7 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Cardiac Failure
|
0.60%
9/1491 • Number of events 11 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Cardiac Failure Acute
|
1.7%
25/1491 • Number of events 28 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Cardiac Failure Chronic
|
0.13%
2/1491 • Number of events 2 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.34%
5/1491 • Number of events 6 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.27%
4/1491 • Number of events 4 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Cardiogenic Shock
|
0.27%
4/1491 • Number of events 4 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Cardiopulmonary Failure
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Coronary Artery Disease
|
1.1%
16/1491 • Number of events 17 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Intracardiac Thrombus
|
0.13%
2/1491 • Number of events 2 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Ischaemic Cardiomyopathy
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Left Ventricular Failure
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Myocardial Infarction
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Myocardial Rupture
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Tachycardia
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Ventricular Arrhythmia
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.20%
3/1491 • Number of events 3 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Ventricular Septal Defect Acquired
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.13%
2/1491 • Number of events 2 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
General disorders
Accidental Death
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
General disorders
Chest Pain
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
General disorders
Death
|
1.5%
22/1491 • Number of events 22 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
0.13%
2/1491 • Number of events 2 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
General disorders
Sudden Cardiac Death
|
0.87%
13/1491 • Number of events 13 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
General disorders
Sudden Death
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Infections and infestations
Covid-19
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Infections and infestations
Pneumonia
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Infections and infestations
Sepsis
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Nervous system disorders
Cerebellar Infarction
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Nervous system disorders
Cerebral Infarction
|
0.13%
2/1491 • Number of events 2 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.20%
3/1491 • Number of events 3 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Nervous system disorders
Embolic Stroke
|
0.07%
1/1491 • Number of events 2 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Psychiatric disorders
Completed Suicide
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Renal and urinary disorders
Renal Failure
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Vascular disorders
Aortic Stenosis
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
Other adverse events
| Measure |
Enrolled Subjects
n=1491 participants at risk
Subjects who were enrolled in the Improve SCA Bridge Study and were not excluded due to not meeting inclusion/exclusion criteria.
While enrolled patients were separated into "Referred" and "Not-Referred" groups based on the outcomes at the 3-month visit, these groups are not separate treatment arms. It would be misleading to compare adverse events between these groups as patients not referred due to an LVEF above 50% were subsequently not followed and had relatively little exposure when compared with the referred patients.
|
|---|---|
|
Cardiac disorders
Angina Pectoris
|
0.40%
6/1491 • Number of events 6 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Arteriosclerosis Coronary Artery
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Atrioventricular Block
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Cardiac Aneurysm
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Cardiac disorders
Cardiac Ventricular Thrombosis
|
0.27%
4/1491 • Number of events 4 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Nervous system disorders
Dizziness Postural
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Nervous system disorders
Syncope
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.07%
1/1491 • Number of events 1 • Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
|
Additional Information
CRM Clinical Research
Medtronic Cardiac Rhythm Management
Results disclosure agreements
- Principal investigator is a sponsor employee In most cases, the contract allows the principal investigator to publish their data after release of a multi-center publication per the publication strategy following Medtronic's review for disclosure of confidential information ("CI"), technical correctness, disclosure of patentable or copyrightable material, and selection and order of publications by the publications committee. Any such CI and/or item identified as not technically correct is deleted prior to publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER