Trial Outcomes & Findings for 2019-06 TRISCEND Study (NCT NCT04221490)
NCT ID: NCT04221490
Last Updated: 2026-01-09
Results Overview
Composite of major adverse events (MAE) defined as cardiovascular mortality, myocardial infarction, stroke, renal complications requiring unplanned dialysis or renal replacement therapy, severe bleeding, unplanned or emergency tricuspid valve re-intervention, major access site and vascular complications, major access site and vascular complications, and device-related pulmonary embolism at 30 days.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
228 participants
Primary outcome timeframe
30 Days
Results posted on
2026-01-09
Participant Flow
Participant milestones
| Measure |
Edwards EVOQUE Tricuspid Valve Replacement System
Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System
|
|---|---|
|
At 30 Days Follow-up
STARTED
|
228
|
|
At 30 Days Follow-up
COMPLETED
|
215
|
|
At 30 Days Follow-up
NOT COMPLETED
|
13
|
|
At 6 Months Follow-up
STARTED
|
219
|
|
At 6 Months Follow-up
COMPLETED
|
194
|
|
At 6 Months Follow-up
NOT COMPLETED
|
25
|
|
At 1 Year Follow-up
STARTED
|
202
|
|
At 1 Year Follow-up
COMPLETED
|
183
|
|
At 1 Year Follow-up
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Edwards EVOQUE Tricuspid Valve Replacement System
Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System
|
|---|---|
|
At 30 Days Follow-up
Death
|
7
|
|
At 30 Days Follow-up
Physician Decision
|
1
|
|
At 30 Days Follow-up
Missed Visit
|
4
|
|
At 30 Days Follow-up
Exited for Other Reasons
|
1
|
|
At 6 Months Follow-up
Death
|
9
|
|
At 6 Months Follow-up
Missed Visit
|
8
|
|
At 6 Months Follow-up
Exited for Other Reasons
|
8
|
|
At 1 Year Follow-up
Death
|
7
|
|
At 1 Year Follow-up
Withdrawal by Subject
|
2
|
|
At 1 Year Follow-up
Missed Visit
|
9
|
|
At 1 Year Follow-up
Exited for Other Reasons
|
1
|
Baseline Characteristics
2019-06 TRISCEND Study
Baseline characteristics by cohort
| Measure |
Edwards EVOQUE Tricuspid Valve Replacement System
n=228 Participants
Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System
|
|---|---|
|
Age, Continuous
|
78.5 Years
STANDARD_DEVIATION 7.30 • n=8 Participants
|
|
Sex: Female, Male
Female
|
162 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
16 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
165 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Not Applicable
|
30 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 Participants
n=8 Participants
|
|
NYHA Class
Class I
|
3 Participants
n=8 Participants
|
|
NYHA Class
Class II
|
66 Participants
n=8 Participants
|
|
NYHA Class
Class III
|
152 Participants
n=8 Participants
|
|
NYHA Class
Class IV
|
7 Participants
n=8 Participants
|
|
Tricuspid Valve Disease Etiology
Primary (Degenerative, Organic, Structural, or Pacer-related)
|
27 Participants
n=8 Participants
|
|
Tricuspid Valve Disease Etiology
Secondary (Functional or Non-structural)
|
159 Participants
n=8 Participants
|
|
Tricuspid Valve Disease Etiology
Mixed
|
32 Participants
n=8 Participants
|
|
Tricuspid Valve Disease Etiology
Indeterminate
|
10 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 30 DaysPopulation: Analysis includes patients who had an MAE or who were followed for at least 30 days. Patients may experience more than one MAE.
Composite of major adverse events (MAE) defined as cardiovascular mortality, myocardial infarction, stroke, renal complications requiring unplanned dialysis or renal replacement therapy, severe bleeding, unplanned or emergency tricuspid valve re-intervention, major access site and vascular complications, major access site and vascular complications, and device-related pulmonary embolism at 30 days.
Outcome measures
| Measure |
Edwards EVOQUE Tricuspid Valve Replacement System
n=226 Participants
Treatment with the Edwards EVOQUE Tricuspid Valve Replacement System
|
|---|---|
|
Composite Major Adverse Events (MAEs)
|
38 Participants
|
PRIMARY outcome
Timeframe: IntraproceduralPopulation: Per device analysis as participants may have more than one device attempted
Study device is deployed as intended and the delivery system is successfully retrieved as intended at the time of the patient's exit from the cardiac catheterization laboratory.
Outcome measures
| Measure |
Edwards EVOQUE Tricuspid Valve Replacement System
n=223 Device
Treatment with the Edwards EVOQUE Tricuspid Valve Replacement System
|
|---|---|
|
Device Success
|
218 Device
|
PRIMARY outcome
Timeframe: Discharge (Up to 7 days post procedure)Population: The outcome is reported where data are available.
Device success without clinically significant paravalvular leak (PVL) on a transthoracic echocardiogram (assessed by the echo core lab) at time of discharge.
Outcome measures
| Measure |
Edwards EVOQUE Tricuspid Valve Replacement System
n=220 Participants
Treatment with the Edwards EVOQUE Tricuspid Valve Replacement System
|
|---|---|
|
Procedure Success
|
212 Participants
|
PRIMARY outcome
Timeframe: 30 DaysPopulation: The outcome is reported where data are available.
Procedural success without MAEs at 30 days.
Outcome measures
| Measure |
Edwards EVOQUE Tricuspid Valve Replacement System
n=221 Participants
Treatment with the Edwards EVOQUE Tricuspid Valve Replacement System
|
|---|---|
|
Clinical Success
|
179 Participants
|
PRIMARY outcome
Timeframe: Discharge (Up to 7 days post procedure)Population: The outcome is reported where data are available.
Percentage of patients with at least 1 grade reduction in tricuspid regurgitation (TR) as measured by using a 5-grade classification system (mild, moderate, severe, massive, torrential). TR grade is assessed by an independent echocardiography core laboratory.
Outcome measures
| Measure |
Edwards EVOQUE Tricuspid Valve Replacement System
n=220 Participants
Treatment with the Edwards EVOQUE Tricuspid Valve Replacement System
|
|---|---|
|
Tricuspid Regurgitation Reduction
|
220 Participants
|
SECONDARY outcome
Timeframe: Baseline, 30 Days, 6 MonthsPopulation: The outcome is reported where data are available. Follow-up in the TRISCEND study is ongoing. Results beyond 6 months will be posted after completion of full follow-up.
Tricuspid regurgitation (TR) is measured by transthoracic echocardiogram (TTE) at each visit using a 5-grade classification system (mild, moderate, severe, massive, torrential). TR grade is assessed by an independent echocardiography core laboratory.
Outcome measures
| Measure |
Edwards EVOQUE Tricuspid Valve Replacement System
n=222 Participants
Treatment with the Edwards EVOQUE Tricuspid Valve Replacement System
|
|---|---|
|
Tricuspid Regurgitation (TR) Grade
30 Days · Moderate
|
5 Participants
|
|
Tricuspid Regurgitation (TR) Grade
30 Days · Severe
|
0 Participants
|
|
Tricuspid Regurgitation (TR) Grade
30 Days · Massive
|
0 Participants
|
|
Tricuspid Regurgitation (TR) Grade
30 Days · Torrential
|
0 Participants
|
|
Tricuspid Regurgitation (TR) Grade
6 Months · None/Trace
|
119 Participants
|
|
Tricuspid Regurgitation (TR) Grade
6 Months · Mild
|
59 Participants
|
|
Tricuspid Regurgitation (TR) Grade
6 Months · Moderate
|
2 Participants
|
|
Tricuspid Regurgitation (TR) Grade
6 Months · Severe
|
0 Participants
|
|
Tricuspid Regurgitation (TR) Grade
6 Months · Massive
|
0 Participants
|
|
Tricuspid Regurgitation (TR) Grade
6 Months · Torrential
|
0 Participants
|
|
Tricuspid Regurgitation (TR) Grade
Baseline · Massive
|
54 Participants
|
|
Tricuspid Regurgitation (TR) Grade
Baseline · Torrential
|
58 Participants
|
|
Tricuspid Regurgitation (TR) Grade
30 Days · None/Trace
|
158 Participants
|
|
Tricuspid Regurgitation (TR) Grade
30 Days · Mild
|
45 Participants
|
|
Tricuspid Regurgitation (TR) Grade
Baseline · None/Trace
|
0 Participants
|
|
Tricuspid Regurgitation (TR) Grade
Baseline · Mild
|
0 Participants
|
|
Tricuspid Regurgitation (TR) Grade
Baseline · Moderate
|
25 Participants
|
|
Tricuspid Regurgitation (TR) Grade
Baseline · Severe
|
85 Participants
|
SECONDARY outcome
Timeframe: Baseline, 30 Days, 6 MonthsPopulation: The outcome is reported where data are available. Follow-up in the TRISCEND study is ongoing. Results beyond 6 months will be posted after completion of full follow-up.
NYHA Functional Classification - The stages of heart failure: Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest.
Outcome measures
| Measure |
Edwards EVOQUE Tricuspid Valve Replacement System
n=222 Participants
Treatment with the Edwards EVOQUE Tricuspid Valve Replacement System
|
|---|---|
|
New York Heart Association (NYHA) Functional Class
Baseline · Class I
|
3 Participants
|
|
New York Heart Association (NYHA) Functional Class
Baseline · Class II
|
65 Participants
|
|
New York Heart Association (NYHA) Functional Class
Baseline · Class III
|
147 Participants
|
|
New York Heart Association (NYHA) Functional Class
Baseline · Class IV
|
7 Participants
|
|
New York Heart Association (NYHA) Functional Class
30 Days · Class I
|
53 Participants
|
|
New York Heart Association (NYHA) Functional Class
30 Days · Class II
|
120 Participants
|
|
New York Heart Association (NYHA) Functional Class
30 Days · Class III
|
31 Participants
|
|
New York Heart Association (NYHA) Functional Class
30 Days · Class IV
|
3 Participants
|
|
New York Heart Association (NYHA) Functional Class
6 Months · Class I
|
68 Participants
|
|
New York Heart Association (NYHA) Functional Class
6 Months · Class II
|
96 Participants
|
|
New York Heart Association (NYHA) Functional Class
6 Months · Class III
|
14 Participants
|
|
New York Heart Association (NYHA) Functional Class
6 Months · Class IV
|
2 Participants
|
SECONDARY outcome
Timeframe: 30 Days, 6 MonthsPopulation: The outcome is reported where data are available. Follow-up in the TRISCEND study is ongoing. Results beyond 6 months will be posted after completion of full follow-up.
Mean distance in meters walked during Six Minute Walk Test (6MWT) at each follow-up visit compared to baseline. 6MWT is a submaximal exercise test that measures the distance that a patient can walk on a flat surface in a period of 6 minutes.
Outcome measures
| Measure |
Edwards EVOQUE Tricuspid Valve Replacement System
n=222 Participants
Treatment with the Edwards EVOQUE Tricuspid Valve Replacement System
|
|---|---|
|
Change in Six Minute Walk Test (6WMT) Distance
30 Days
|
41.3 meters
Standard Deviation 85.63
|
|
Change in Six Minute Walk Test (6WMT) Distance
6 Months
|
52.6 meters
Standard Deviation 96.57
|
SECONDARY outcome
Timeframe: 30 Days, 6 MonthsPopulation: The outcome is reported where data are available. Follow-up in the TRISCEND study is ongoing. Results beyond 6 months will be posted after completion of full follow-up.
Mean KCCQ score at each follow-up visit compared to baseline. The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status.
Outcome measures
| Measure |
Edwards EVOQUE Tricuspid Valve Replacement System
n=222 Participants
Treatment with the Edwards EVOQUE Tricuspid Valve Replacement System
|
|---|---|
|
Change in Quality of Life Score as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
30 Days
|
20.6 points
Standard Deviation 24.71
|
|
Change in Quality of Life Score as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
6 Months
|
27.2 points
Standard Deviation 22.20
|
SECONDARY outcome
Timeframe: 30 Days, 6 MonthsPopulation: The outcome is reported where data are available. Follow-up in the TRISCEND study is ongoing. Results beyond 6 months will be posted after completion of full follow-up.
Mean change in SF-36 mental score at each follow-up visit compared to baseline compared to baseline. The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Outcome measures
| Measure |
Edwards EVOQUE Tricuspid Valve Replacement System
n=222 Participants
Treatment with the Edwards EVOQUE Tricuspid Valve Replacement System
|
|---|---|
|
Change in Quality of Life as Measured by 36-Item Short Form Health Survey (SF-36) Mental Score
30 Days
|
4.2 points
Standard Deviation 13.38
|
|
Change in Quality of Life as Measured by 36-Item Short Form Health Survey (SF-36) Mental Score
6 Months
|
6.2 points
Standard Deviation 11.50
|
SECONDARY outcome
Timeframe: 30 Days, 6 MonthsPopulation: The outcome is reported where data are available. Follow-up in the TRISCEND study is ongoing. Results beyond 6 months will be posted after completion of full follow-up.
Mean change in SF-36 physical score at each follow-up visit compared to baseline. The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Outcome measures
| Measure |
Edwards EVOQUE Tricuspid Valve Replacement System
n=222 Participants
Treatment with the Edwards EVOQUE Tricuspid Valve Replacement System
|
|---|---|
|
Change in Quality of Life as Measured by 36-Item Short Form Health Survey (SF-36) Physical Score
30 Days
|
5.1 points
Standard Deviation 8.46
|
|
Change in Quality of Life as Measured by 36-Item Short Form Health Survey (SF-36) Physical Score
6 Months
|
6.7 points
Standard Deviation 9.35
|
SECONDARY outcome
Timeframe: 30 Days, 6 MonthsPopulation: The outcome is reported where data are available. Follow-up in the TRISCEND study is ongoing. Results beyond 6 months will be posted after completion of full follow-up.
Mean change in body weight in kilograms at each follow-up visit compared to baseline.
Outcome measures
| Measure |
Edwards EVOQUE Tricuspid Valve Replacement System
n=222 Participants
Treatment with the Edwards EVOQUE Tricuspid Valve Replacement System
|
|---|---|
|
Change in Body Weight
30 Days
|
-2.2 kilograms
Standard Deviation 4.92
|
|
Change in Body Weight
6 Months
|
-2.1 kilograms
Standard Deviation 5.90
|
SECONDARY outcome
Timeframe: 30 Days, 6 MonthsPopulation: The outcome is reported where data are available. Follow-up in the TRISCEND study is ongoing. Results beyond 6 months will be posted after completion of full follow-up.
Mean change in left ankle circumference in centimeters at each follow-up visit compared to baseline.
Outcome measures
| Measure |
Edwards EVOQUE Tricuspid Valve Replacement System
n=222 Participants
Treatment with the Edwards EVOQUE Tricuspid Valve Replacement System
|
|---|---|
|
Change in Left Ankle Circumference
30 Days
|
-0.80 centimeters
Standard Deviation 2.836
|
|
Change in Left Ankle Circumference
6 Months
|
-0.60 centimeters
Standard Deviation 2.439
|
SECONDARY outcome
Timeframe: 30 Days, 6 MonthsPopulation: The outcome is reported where data are available. Follow-up in the TRISCEND study is ongoing. Results beyond 6 months will be posted after completion of full follow-up.
Mean change in right ankle circumference in centimeters at each follow-up visit compared to baseline.
Outcome measures
| Measure |
Edwards EVOQUE Tricuspid Valve Replacement System
n=222 Participants
Treatment with the Edwards EVOQUE Tricuspid Valve Replacement System
|
|---|---|
|
Change in Right Ankle Circumference
30 Days
|
-0.67 centimeters
Standard Deviation 2.839
|
|
Change in Right Ankle Circumference
6 Months
|
-0.52 centimeters
Standard Deviation 2.685
|
SECONDARY outcome
Timeframe: Baseline, 30 Days, 6 MonthsPopulation: The outcome is reported where data are available. Follow-up in the TRISCEND study is ongoing. Results beyond 6 months will be posted after completion of full follow-up.
The edema grading scale measures how quickly the dimple goes back to normal (rebound) after a pitting test. The scale includes: Grade 1: Immediate rebound with 0 to 2 millimeter (mm) pit. Grade 2: Less than 15-second rebound with 3 to 4 mm pit. Grade 3: Rebound greater than 15 seconds but less than 60 seconds with 5 to 6 mm pit. Grade 4: Rebound between 2 to 3 minutes with an 8 mm pit.
Outcome measures
| Measure |
Edwards EVOQUE Tricuspid Valve Replacement System
n=222 Participants
Treatment with the Edwards EVOQUE Tricuspid Valve Replacement System
|
|---|---|
|
Edema Assessment By Visit
Baseline · Absent
|
73 Participants
|
|
Edema Assessment By Visit
Baseline · Grade 1+
|
83 Participants
|
|
Edema Assessment By Visit
Baseline · Grade 2+
|
47 Participants
|
|
Edema Assessment By Visit
Baseline · Grade 3+
|
19 Participants
|
|
Edema Assessment By Visit
Baseline · Grade 4+
|
0 Participants
|
|
Edema Assessment By Visit
30 Days · Absent
|
98 Participants
|
|
Edema Assessment By Visit
30 Days · Grade 1+
|
74 Participants
|
|
Edema Assessment By Visit
30 Days · Grade 2+
|
20 Participants
|
|
Edema Assessment By Visit
30 Days · Grade 3+
|
8 Participants
|
|
Edema Assessment By Visit
30 Days · Grade 4+
|
2 Participants
|
|
Edema Assessment By Visit
6 Months · Absent
|
99 Participants
|
|
Edema Assessment By Visit
6 Months · Grade 1+
|
68 Participants
|
|
Edema Assessment By Visit
6 Months · Grade 2+
|
10 Participants
|
|
Edema Assessment By Visit
6 Months · Grade 3+
|
5 Participants
|
|
Edema Assessment By Visit
6 Months · Grade 4+
|
0 Participants
|
Adverse Events
Edwards EVOQUE Tricuspid Valve Replacement System
Serious events: 148 serious events
Other events: 99 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
Edwards EVOQUE Tricuspid Valve Replacement System
n=228 participants at risk
Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System
|
|---|---|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Vascular disorders
Aortic stenosis
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Cardiac disorders
Aortic valve stenosis
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Cardiac disorders
Arrhythmia
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Cardiac disorders
Atrioventricular block
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Cardiac disorders
Atrioventricular block complete
|
6.1%
14/228 • Number of events 14 • 1 year follow up
|
|
Cardiac disorders
Bradycardia
|
4.4%
10/228 • Number of events 10 • 1 year follow up
|
|
Cardiac disorders
Bundle branch block right
|
0.88%
2/228 • Number of events 2 • 1 year follow up
|
|
Infections and infestations
COVID-19
|
0.88%
2/228 • Number of events 2 • 1 year follow up
|
|
Infections and infestations
COVID-19 pneumonia
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Endocrine disorders
Carcinoid syndrome
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Cardiac disorders
Cardiac arrest
|
3.1%
7/228 • Number of events 7 • 1 year follow up
|
|
Cardiac disorders
Cardiac failure
|
8.3%
19/228 • Number of events 23 • 1 year follow up
|
|
Cardiac disorders
Cardiogenic shock
|
1.8%
4/228 • Number of events 4 • 1 year follow up
|
|
Vascular disorders
Haemorrhage
|
1.3%
3/228 • Number of events 3 • 1 year follow up
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.88%
2/228 • Number of events 2 • 1 year follow up
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Infections and infestations
Infection
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.44%
1/228 • Number of events 2 • 1 year follow up
|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Cardiac disorders
Palpitations
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.2%
5/228 • Number of events 5 • 1 year follow up
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Cardiac disorders
Coronary artery disease
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Vascular disorders
Haematoma
|
2.6%
6/228 • Number of events 6 • 1 year follow up
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
1.3%
3/228 • Number of events 3 • 1 year follow up
|
|
Vascular disorders
Hypovolaemic shock
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Cardiac disorders
Mitral valve stenosis
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
General disorders
Pyrexia
|
2.2%
5/228 • Number of events 5 • 1 year follow up
|
|
Cardiac disorders
Cardiac tamponade
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Nervous system disorders
Carotid artery stenosis
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
General disorders
Chest pain
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Vascular disorders
Hypotension
|
1.8%
4/228 • Number of events 4 • 1 year follow up
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Investigations
International normalised ratio increased
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Psychiatric disorders
Mania
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Cardiac disorders
Mitral valve incompetence
|
1.3%
3/228 • Number of events 3 • 1 year follow up
|
|
Infections and infestations
Pneumonia aspiration
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Infections and infestations
Bacteraemia
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Investigations
Blood lactic acid increased
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Cardiac disorders
Cardiac failure acute
|
5.3%
12/228 • Number of events 12 • 1 year follow up
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Cardiac disorders
Conduction disorder
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Vascular disorders
Deep vein thrombosis
|
2.2%
5/228 • Number of events 5 • 1 year follow up
|
|
Metabolism and nutrition disorders
Gout
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Infections and infestations
Labyrinthitis
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
General disorders
Medical device site erosion
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Nervous system disorders
Metabolic encephalopathy
|
1.8%
4/228 • Number of events 5 • 1 year follow up
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.88%
2/228 • Number of events 2 • 1 year follow up
|
|
General disorders
Prosthetic cardiac valve regurgitation
|
0.88%
2/228 • Number of events 2 • 1 year follow up
|
|
Blood and lymphatic system disorders
Anaemia
|
6.6%
15/228 • Number of events 16 • 1 year follow up
|
|
General disorders
Device embolisation
|
0.88%
2/228 • Number of events 2 • 1 year follow up
|
|
Infections and infestations
Endocarditis bacterial
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
7.5%
17/228 • Number of events 20 • 1 year follow up
|
|
Eye disorders
Glaucoma
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Cardiac disorders
Left ventricular failure
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.88%
2/228 • Number of events 2 • 1 year follow up
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Cardiac disorders
Nodal rhythm
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
General disorders
Prosthetic cardiac valve thrombosis
|
1.3%
3/228 • Number of events 3 • 1 year follow up
|
|
Infections and infestations
Pseudomonal sepsis
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Infections and infestations
Pyelonephritis acute
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Cardiac disorders
Atrial fibrillation
|
3.9%
9/228 • Number of events 9 • 1 year follow up
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Vascular disorders
Distributive shock
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.3%
3/228 • Number of events 3 • 1 year follow up
|
|
Cardiac disorders
Heart failure with preserved ejection fraction
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Gastrointestinal disorders
Melaena
|
0.88%
2/228 • Number of events 2 • 1 year follow up
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Cardiac disorders
Cardiac failure chronic
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Cardiac disorders
Cardiac failure congestive
|
3.1%
7/228 • Number of events 8 • 1 year follow up
|
|
General disorders
Death
|
0.88%
2/228 • Number of events 2 • 1 year follow up
|
|
Infections and infestations
Endocarditis
|
0.88%
2/228 • Number of events 2 • 1 year follow up
|
|
Injury, poisoning and procedural complications
Incision site complication
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Nervous system disorders
Cerebrovascular accident
|
0.88%
2/228 • Number of events 2 • 1 year follow up
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Renal and urinary disorders
Acute kidney injury
|
7.5%
17/228 • Number of events 17 • 1 year follow up
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Cardiac disorders
Myocardial infarction
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Nervous system disorders
Presyncope
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Product Issues
Device dislocation
|
2.6%
6/228 • Number of events 6 • 1 year follow up
|
|
Vascular disorders
Hypertension
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Product Issues
Lead dislodgement
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Gastrointestinal disorders
Mesenteric haemorrhage
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
General disorders
Necrosis
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Cardiac disorders
Nodal arrhythmia
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Infections and infestations
Cellulitis
|
0.88%
2/228 • Number of events 2 • 1 year follow up
|
|
Infections and infestations
Pneumonia
|
2.2%
5/228 • Number of events 5 • 1 year follow up
|
|
Endocrine disorders
Adrenal insufficiency
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Infections and infestations
Diverticulitis
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Nervous system disorders
Encephalopathy
|
1.3%
3/228 • Number of events 3 • 1 year follow up
|
|
Injury, poisoning and procedural complications
Fall
|
0.88%
2/228 • Number of events 2 • 1 year follow up
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Cardiac disorders
Right ventricular dysfunction
|
2.2%
5/228 • Number of events 5 • 1 year follow up
|
|
Cardiac disorders
Right ventricular failure
|
2.6%
6/228 • Number of events 7 • 1 year follow up
|
|
Cardiac disorders
Sinus node dysfunction
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Cardiac disorders
Ventricular tachycardia
|
1.8%
4/228 • Number of events 4 • 1 year follow up
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Gastrointestinal disorders
Volvulus
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
General disorders
Sudden cardiac death
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Infections and infestations
Sepsis
|
0.88%
2/228 • Number of events 2 • 1 year follow up
|
|
Infections and infestations
Septic shock
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Infections and infestations
Staphylococcal infection
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Infections and infestations
Urinary tract infection
|
0.88%
2/228 • Number of events 2 • 1 year follow up
|
|
Infections and infestations
Urosepsis
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Injury, poisoning and procedural complications
Retroperitoneal haemorrhage
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Injury, poisoning and procedural complications
Stomal hernia
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.88%
2/228 • Number of events 2 • 1 year follow up
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
0.88%
2/228 • Number of events 2 • 1 year follow up
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
1.3%
3/228 • Number of events 3 • 1 year follow up
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.88%
2/228 • Number of events 2 • 1 year follow up
|
|
Injury, poisoning and procedural complications
Vessel puncture site haemorrhage
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Nervous system disorders
Transient ischaemic attack
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Renal and urinary disorders
Renal failure
|
0.88%
2/228 • Number of events 2 • 1 year follow up
|
|
Renal and urinary disorders
Renal mass
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Renal and urinary disorders
Urinary retention
|
0.88%
2/228 • Number of events 2 • 1 year follow up
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.8%
4/228 • Number of events 4 • 1 year follow up
|
|
Vascular disorders
Shock haemorrhagic
|
1.3%
3/228 • Number of events 4 • 1 year follow up
|
|
Vascular disorders
Air embolism
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Cardiac disorders
Atrial thrombosis
|
1.3%
3/228 • Number of events 3 • 1 year follow up
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Infections and infestations
Diverticulitis intestinal perforated
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Gastrointestinal disorders
Dysphagia
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
|
Cardiac disorders
Acute left ventricular failure
|
0.44%
1/228 • Number of events 1 • 1 year follow up
|
Other adverse events
| Measure |
Edwards EVOQUE Tricuspid Valve Replacement System
n=228 participants at risk
Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System
|
|---|---|
|
Cardiac disorders
Bundle branch block right
|
8.8%
20/228 • Number of events 20 • 1 year follow up
|
|
Renal and urinary disorders
Acute kidney injury
|
9.2%
21/228 • Number of events 22 • 1 year follow up
|
|
Blood and lymphatic system disorders
Anaemia
|
5.7%
13/228 • Number of events 13 • 1 year follow up
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.3%
19/228 • Number of events 19 • 1 year follow up
|
|
Cardiac disorders
Atrial fibrillation
|
6.6%
15/228 • Number of events 15 • 1 year follow up
|
|
Cardiac disorders
Cardiac failure
|
7.0%
16/228 • Number of events 18 • 1 year follow up
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
7.9%
18/228 • Number of events 18 • 1 year follow up
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
5.3%
12/228 • Number of events 13 • 1 year follow up
|
|
Investigations
Troponin increased
|
7.0%
16/228 • Number of events 16 • 1 year follow up
|
|
Vascular disorders
Hypotension
|
5.3%
12/228 • Number of events 12 • 1 year follow up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place