Trial Outcomes & Findings for Medtronic CoreValve Evolut R U.S. Clinical Study (Evolut 34R Addendum) (NCT NCT02746809)
NCT ID: NCT02746809
Last Updated: 2023-05-03
Results Overview
Percentage of participants with all-cause mortality at 30 days
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
30 Days
Results posted on
2023-05-03
Participant Flow
Participant milestones
| Measure |
CoreValve Evolut R TAVR System 34R Valve
The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut 34R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R 20Fr Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
|
|---|---|
|
Enrollment
STARTED
|
72
|
|
Enrollment
COMPLETED
|
60
|
|
Enrollment
NOT COMPLETED
|
12
|
|
Procedure
STARTED
|
60
|
|
Procedure
COMPLETED
|
59
|
|
Procedure
NOT COMPLETED
|
1
|
|
1-Month
STARTED
|
59
|
|
1-Month
COMPLETED
|
54
|
|
1-Month
NOT COMPLETED
|
5
|
|
6-Month
STARTED
|
54
|
|
6-Month
COMPLETED
|
51
|
|
6-Month
NOT COMPLETED
|
3
|
|
12-Month
STARTED
|
51
|
|
12-Month
COMPLETED
|
46
|
|
12-Month
NOT COMPLETED
|
5
|
|
24-Month
STARTED
|
46
|
|
24-Month
COMPLETED
|
44
|
|
24-Month
NOT COMPLETED
|
2
|
|
36-Month
STARTED
|
44
|
|
36-Month
COMPLETED
|
35
|
|
36-Month
NOT COMPLETED
|
9
|
|
48-Month
STARTED
|
35
|
|
48-Month
COMPLETED
|
27
|
|
48-Month
NOT COMPLETED
|
8
|
|
60-Month
STARTED
|
27
|
|
60-Month
COMPLETED
|
24
|
|
60-Month
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
CoreValve Evolut R TAVR System 34R Valve
The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut 34R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R 20Fr Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
|
|---|---|
|
Enrollment
Inclusion Exclusion not met
|
9
|
|
Enrollment
Withdrawal by Subject
|
1
|
|
Enrollment
Expected Enrollment Met
|
2
|
|
Procedure
Death
|
1
|
|
1-Month
Death
|
5
|
|
6-Month
Death
|
2
|
|
6-Month
Withdrawal by Subject
|
1
|
|
12-Month
Death
|
3
|
|
12-Month
Withdrawal by Subject
|
2
|
|
24-Month
Death
|
1
|
|
24-Month
Withdrawal by Subject
|
1
|
|
36-Month
Death
|
8
|
|
36-Month
Withdrawal by Subject
|
1
|
|
48-Month
Death
|
7
|
|
48-Month
Withdrawal by Subject
|
1
|
|
60-Month
Death
|
1
|
|
60-Month
Lost to Follow-up
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
CoreValve Evolut 34R TAVR System
n=60 Participants
Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.\>
\> CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:\>
1. Evolut 34R Transcatheter Aortic Valve (TAV)\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath\>
3. EnVeo R Loading System (LS)
|
|---|---|
|
Age, Continuous
|
81.8 years
STANDARD_DEVIATION 8.2 • n=60 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=60 Participants
|
|
Region of Enrollment
United States
|
60 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: 30 DaysPercentage of participants with all-cause mortality at 30 days
Outcome measures
| Measure |
CoreValve Evolut 34R TAVR System
n=60 Participants
Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.
\>
\>
CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut 34R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
|
|---|---|
|
Percentage of Participants With All-cause Mortality
|
1.7 percentage of participants
Interval 0.2 to 11.2
|
PRIMARY outcome
Timeframe: 30 DaysPercentage of participants with disabling stroke (VARC-II definitions) at 30 days
Outcome measures
| Measure |
CoreValve Evolut 34R TAVR System
n=60 Participants
Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.
\>
\>
CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut 34R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
|
|---|---|
|
Percentage of Participants With Stroke (Disabling)
|
0.0 percentage of participants
Interval 0.0 to 6.1
|
PRIMARY outcome
Timeframe: 24 hours to 7 days post implantationDevice Success defined as: * Absence of procedural mortality, AND * Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND * Intended performance of the prosthetic heart valve, defined as the absence of patient prosthesis-mismatch and mean gradient \< 20 mmHg (or peak velocity \< 3 m/sec), AND * Absence of moderate or severe prosthetic valve regurgitation
Outcome measures
| Measure |
CoreValve Evolut 34R TAVR System
n=60 Participants
Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.
\>
\>
CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut 34R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
|
|---|---|
|
Device Success Rate
|
79.2 percentage of participants
Interval 65.9 to 89.2
|
PRIMARY outcome
Timeframe: 24 hours to 7 days post implantationThe percentage of subjects with no more than mild prosthetic regurgitation at early post procedure echocardiogram as assessed by echo core laboratory
Outcome measures
| Measure |
CoreValve Evolut 34R TAVR System
n=60 Participants
Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.
\>
\>
CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut 34R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
|
|---|---|
|
The Percentage of Subjects With no More Than Mild Prosthetic Regurgitation at Early Post Procedure Echocardiogram
|
100.0 percentage of participants
Interval 93.9 to 100.0
|
SECONDARY outcome
Timeframe: 30 days post-implantationVARC II composite safety endpoint includes the following components: * All-cause mortality * All stroke (disabling and non-disabling) * Life-threatening bleeding * Acute kidney injury: stage 2 or 3 (including renal replacement therapy). * Coronary artery obstruction requiring intervention. * Major vascular complication. * Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)
Outcome measures
| Measure |
CoreValve Evolut 34R TAVR System
n=60 Participants
Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.
\>
\>
CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut 34R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
|
|---|---|
|
Percentage of Participants With VARC II Combined Safety Endpoint Event at 30 Days
|
5.0 percentage of participants
Interval 1.6 to 14.7
|
SECONDARY outcome
Timeframe: 30 days post-implantationPercentage of participants with life threatening or disabling bleeding - see VARC-2 definitions for classification details
Outcome measures
| Measure |
CoreValve Evolut 34R TAVR System
n=60 Participants
Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.
\>
\>
CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut 34R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
|
|---|---|
|
Percentage of Participants With Life Threatening or Disabling Bleeding
|
1.7 percentage of participants
Interval 0.2 to 11.4
|
SECONDARY outcome
Timeframe: 30 daysPercentage of participants with Major vascular complication - see VARC-2 definitions for additional details
Outcome measures
| Measure |
CoreValve Evolut 34R TAVR System
n=60 Participants
Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.
\>
\>
CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut 34R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
|
|---|---|
|
Percentage of Participants With Major Vascular Complication
|
1.7 percentage of participants
Interval 0.2 to 11.4
|
SECONDARY outcome
Timeframe: 30 daysPercentage of participants with Acute Kidney Injury: Stage 2 or 3 - see VARC-2 definitions for additional details
Outcome measures
| Measure |
CoreValve Evolut 34R TAVR System
n=60 Participants
Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.
\>
\>
CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut 34R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
|
|---|---|
|
Percentage of Participants With Acute Kidney Injury: Stage 2 or 3
|
0.0 percentage of participants
Interval 0.0 to 6.1
|
SECONDARY outcome
Timeframe: 30 daysPercentage of participants with coronary artery obstruction - see VARC-2 definitions for additional details
Outcome measures
| Measure |
CoreValve Evolut 34R TAVR System
n=60 Participants
Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.
\>
\>
CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut 34R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
|
|---|---|
|
Percentage of Participants With Coronary Artery Obstruction
|
0.0 percentage of participants
Interval 0.0 to 6.1
|
SECONDARY outcome
Timeframe: 30 daysPercentage of subjects with valve-related dysfunction requiring repeat procedure - see VARC-2 definitions for additional details
Outcome measures
| Measure |
CoreValve Evolut 34R TAVR System
n=60 Participants
Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.
\>
\>
CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut 34R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
|
|---|---|
|
Percentage of Subjects With Valve-related Dysfunction Requiring Repeat Procedure
|
0.0 percentage of participants
Interval 0.0 to 6.1
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Subjects with pre-existing pacemaker or internal cardiac defibrillator were excluded from analysis.
Percentage of subjects with new permanent pacemaker implant at 30 days.
Outcome measures
| Measure |
CoreValve Evolut 34R TAVR System
n=42 Participants
Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.
\>
\>
CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut 34R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
|
|---|---|
|
Percentage of Subjects With Permanent Pacemaker Implant at 30 Days
|
20.8 percentage of participants
Interval 12.1 to 34.3
|
SECONDARY outcome
Timeframe: Implant procedurePopulation: Success could only be analyzed in subjects where the resheath/recapture feature was used.
Successful resheathing is defined as Evolut R TAV (including frame) was resheathed into the capsule of the delivery cathether to the desired amount intended, as verified by fluoroscopy. Successful recapture is defined as the entire Evolut R TAV (including frame) is resheathed into the capsule of the delivery catheter until there is no gap between the capsule and the tip, as verified by fluoroscopy.
Outcome measures
| Measure |
CoreValve Evolut 34R TAVR System
n=26 Participants
Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.
\>
\>
CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut 34R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
|
|---|---|
|
Percentage of Resheath and Recapture Success
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Only participants with echo could be analyzed.
Mean gradient (mmHg) as measured by transthoracic echocardiogram and assessed by echo core laboratory
Outcome measures
| Measure |
CoreValve Evolut 34R TAVR System
n=60 Participants
Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.
\>
\>
CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut 34R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
|
|---|---|
|
Hemodynamic Performance Metrics - Mean Gradient
|
6.4 mmHg
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: Only participants with echo could be analyzed.
Aortic valve area as measured by transthoracic echocardiogram and assessed by echo core laboratory
Outcome measures
| Measure |
CoreValve Evolut 34R TAVR System
n=60 Participants
Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.
\>
\>
CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut 34R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
|
|---|---|
|
Hemodynamic Performance Metrics- Aortic Valve Area
|
2.6 cm2
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Only participants with echo could be analyzed.
Total prosthetic regurgitation (none/trace) as measured by transthoracic echocardiogram and assessed by echo core laboratory
Outcome measures
| Measure |
CoreValve Evolut 34R TAVR System
n=58 Participants
Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.
\>
\>
CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut 34R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
|
|---|---|
|
Hemodynamic Performance Metrics - Total Prosthetic Regurgitation Graded as None/Trace
|
60.3 percentage of participants
|
Adverse Events
EVOLUTR 34R
Serious events: 34 serious events
Other events: 48 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
EVOLUTR 34R
n=60 participants at risk
Participants implanted with EVOLUTR 34R device
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.3%
2/60 • Number of events 2 • All events 6 months, All Cause Mortality 60 months
|
|
Blood and lymphatic system disorders
Coagulopathy
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Acute Myocardial Infarction
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Atrioventricular Block
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Atrioventricular Block Complete
|
13.3%
8/60 • Number of events 8 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Atrioventricular Block First Degree
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Bundle Branch Block Left
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Cardiac Arrest
|
3.3%
2/60 • Number of events 2 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Cardiac Failure Acute
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Cardiac Failure Congestive
|
3.3%
2/60 • Number of events 3 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Cardiogenic Shock
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Conduction Disorder
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Nodal Rhythm
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Pulseless Electrical Activity
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Supraventricular Tachycardia
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Ventricular Tachycardia
|
3.3%
2/60 • Number of events 2 • All events 6 months, All Cause Mortality 60 months
|
|
Eye disorders
Vision Blurred
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
General disorders
Chest Pain
|
3.3%
2/60 • Number of events 2 • All events 6 months, All Cause Mortality 60 months
|
|
General disorders
Device Embolisation
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
General disorders
Generalised Oedema
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
General disorders
Pyrexia
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Infections and infestations
Bronchitis
|
3.3%
2/60 • Number of events 2 • All events 6 months, All Cause Mortality 60 months
|
|
Infections and infestations
Pneumonia
|
6.7%
4/60 • Number of events 4 • All events 6 months, All Cause Mortality 60 months
|
|
Infections and infestations
Sepsis
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Infections and infestations
Viral Infection
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Injury, poisoning and procedural complications
Arterial Injury
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Injury, poisoning and procedural complications
Compression Fracture
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Injury, poisoning and procedural complications
Concussion
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
3.3%
2/60 • Number of events 2 • All events 6 months, All Cause Mortality 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Nervous system disorders
Cerebrovascular Accident
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Nervous system disorders
Dizziness
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Nervous system disorders
Hypoxic-Ischaemic Encephalopathy
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Nervous system disorders
Syncope
|
3.3%
2/60 • Number of events 2 • All events 6 months, All Cause Mortality 60 months
|
|
Nervous system disorders
Transient Ischaemic Attack
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Psychiatric disorders
Confusional State
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Renal and urinary disorders
Glomerulonephritis Membranous
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Renal and urinary disorders
Haematuria
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Renal and urinary disorders
Urinary Retention
|
6.7%
4/60 • Number of events 4 • All events 6 months, All Cause Mortality 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.3%
2/60 • Number of events 2 • All events 6 months, All Cause Mortality 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
3.3%
2/60 • Number of events 2 • All events 6 months, All Cause Mortality 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Vascular disorders
Deep Vein Thrombosis
|
5.0%
3/60 • Number of events 3 • All events 6 months, All Cause Mortality 60 months
|
|
Vascular disorders
Femoral Artery Dissection
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Vascular disorders
Hypertension
|
3.3%
2/60 • Number of events 2 • All events 6 months, All Cause Mortality 60 months
|
|
Vascular disorders
Hypotension
|
3.3%
2/60 • Number of events 2 • All events 6 months, All Cause Mortality 60 months
|
|
Vascular disorders
Peripheral Ischaemia
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
General disorders
All-Cause Mortality
|
46.7%
28/60 • Number of events 28 • All events 6 months, All Cause Mortality 60 months
|
Other adverse events
| Measure |
EVOLUTR 34R
n=60 participants at risk
Participants implanted with EVOLUTR 34R device
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
4/60 • Number of events 4 • All events 6 months, All Cause Mortality 60 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
13.3%
8/60 • Number of events 8 • All events 6 months, All Cause Mortality 60 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
15/60 • Number of events 15 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Atrial Fibrillation
|
10.0%
6/60 • Number of events 6 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Atrioventricular Block First Degree
|
20.0%
12/60 • Number of events 13 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Bundle Branch Block Left
|
28.3%
17/60 • Number of events 17 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Extrasystoles
|
6.7%
4/60 • Number of events 4 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Sinus Bradycardia
|
6.7%
4/60 • Number of events 4 • All events 6 months, All Cause Mortality 60 months
|
|
Infections and infestations
Urinary Tract Infection
|
10.0%
6/60 • Number of events 6 • All events 6 months, All Cause Mortality 60 months
|
|
Investigations
Myocardial Necrosis Marker Increased
|
6.7%
4/60 • Number of events 4 • All events 6 months, All Cause Mortality 60 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.3%
5/60 • Number of events 5 • All events 6 months, All Cause Mortality 60 months
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
20.0%
12/60 • Number of events 12 • All events 6 months, All Cause Mortality 60 months
|
|
Renal and urinary disorders
Haematuria
|
8.3%
5/60 • Number of events 5 • All events 6 months, All Cause Mortality 60 months
|
|
Renal and urinary disorders
Renal Failure
|
6.7%
4/60 • Number of events 4 • All events 6 months, All Cause Mortality 60 months
|
|
Renal and urinary disorders
Urinary Retention
|
6.7%
4/60 • Number of events 4 • All events 6 months, All Cause Mortality 60 months
|
|
Vascular disorders
Hypertension
|
10.0%
6/60 • Number of events 6 • All events 6 months, All Cause Mortality 60 months
|
|
Vascular disorders
Hypotension
|
6.7%
4/60 • Number of events 4 • All events 6 months, All Cause Mortality 60 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place