Trial Outcomes & Findings for PREVAIL-TF: Transfemoral Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe) (NCT NCT00820599)
NCT ID: NCT00820599
Last Updated: 2020-11-02
Results Overview
Number of death at 30-days from the index procedure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
214 participants
Primary outcome timeframe
30 days
Results posted on
2020-11-02
Participant Flow
One patient withdrew prior to procedure. Prior to procedure, two patients were noted as having significant co-morbidities not accounted for by the Euroscore, therefore they were exited from the trial prior to procedure.
Three enrolled subjects did not enter the procedure room.
Participant milestones
| Measure |
TAVR
Transaortic Valve Replacement
Sapien XT™ transcatheter heart valve and delivery system
|
|---|---|
|
Overall Study
STARTED
|
211
|
|
Overall Study
COMPLETED
|
80
|
|
Overall Study
NOT COMPLETED
|
131
|
Reasons for withdrawal
| Measure |
TAVR
Transaortic Valve Replacement
Sapien XT™ transcatheter heart valve and delivery system
|
|---|---|
|
Overall Study
Death
|
129
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
PREVAIL-TF: Transfemoral Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
Baseline characteristics by cohort
| Measure |
TAVR
n=211 Participants
Transaortic Valve Replacement
Sapien XT™ transcatheter heart valve and delivery system
|
|---|---|
|
Age, Continuous
|
83.2 Years
STANDARD_DEVIATION 5.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
142 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
|
STS Risk Score
|
9.1 Units on Scale
STANDARD_DEVIATION 6.29 • n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysNumber of death at 30-days from the index procedure.
Outcome measures
| Measure |
TAVR
n=211 Participants
Transaortic Valve Replacement
Sapien XT™ transcatheter heart valve and delivery system
|
|---|---|
|
Number of Deaths
|
21 Participants
|
SECONDARY outcome
Timeframe: 30 days from the index procedureTotal number of participates with a stroke.
Outcome measures
| Measure |
TAVR
n=211 Participants
Transaortic Valve Replacement
Sapien XT™ transcatheter heart valve and delivery system
|
|---|---|
|
Number of Participants With a Stroke
|
9 Participants
|
Adverse Events
TAVR
Serious events: 193 serious events
Other events: 192 other events
Deaths: 129 deaths
Serious adverse events
| Measure |
TAVR
n=211 participants at risk
Transaortic Valve Replacement
Sapien XT™ transcatheter heart valve and delivery system
|
|---|---|
|
Vascular disorders
Aneurysm
|
0.47%
1/211 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Angina
|
5.2%
11/211 • Number of events 16 • 5 Years
|
|
Injury, poisoning and procedural complications
Annular Dissection
|
0.95%
2/211 • Number of events 2 • 5 Years
|
|
Vascular disorders
Aortic Dissection
|
0.47%
1/211 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Aortic Regurgitation ( 3+ 0r 4+)
|
0.95%
2/211 • Number of events 2 • 5 Years
|
|
Cardiac disorders
Arrhythmia and Pacemaker Implant
|
14.7%
31/211 • Number of events 31 • 5 Years
|
|
Cardiac disorders
Arrhythmia w/o Pacemaker Implant
|
9.5%
20/211 • Number of events 23 • 5 Years
|
|
Vascular disorders
Bleeding Event Major - Not Surgical
|
9.0%
19/211 • Number of events 22 • 5 Years
|
|
Vascular disorders
Bleeding Event Minor - Not Surgical
|
8.5%
18/211 • Number of events 18 • 5 Years
|
|
Injury, poisoning and procedural complications
Bone Fracture
|
11.4%
24/211 • Number of events 26 • 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
7.6%
16/211 • Number of events 20 • 5 Years
|
|
Cardiac disorders
Cardiac Tamponade
|
2.4%
5/211 • Number of events 5 • 5 Years
|
|
Cardiac disorders
Circulatory Disorders
|
1.4%
3/211 • Number of events 4 • 5 Years
|
|
Blood and lymphatic system disorders
Coagulopathy / Hematological Disorder
|
12.8%
27/211 • Number of events 31 • 5 Years
|
|
General disorders
Death
|
61.6%
130/211 • Number of events 130 • 5 Years
|
|
General disorders
Drug Reaction
|
0.47%
1/211 • Number of events 1 • 5 Years
|
|
Vascular disorders
Embolism - Not Stroke - Not TE
|
0.47%
1/211 • Number of events 1 • 5 Years
|
|
Infections and infestations
Endocarditis
|
0.95%
2/211 • Number of events 2 • 5 Years
|
|
Surgical and medical procedures
Explant
|
1.4%
3/211 • Number of events 3 • 5 Years
|
|
General disorders
Fever Unknown Origin
|
1.4%
3/211 • Number of events 3 • 5 Years
|
|
Gastrointestinal disorders
Gastro-Intestinal Compl
|
7.1%
15/211 • Number of events 23 • 5 Years
|
|
Cardiac disorders
Heart Failure
|
33.2%
70/211 • Number of events 123 • 5 Years
|
|
Vascular disorders
Hypertension
|
1.4%
3/211 • Number of events 4 • 5 Years
|
|
Vascular disorders
Hypotension
|
1.9%
4/211 • Number of events 4 • 5 Years
|
|
Infections and infestations
Infection / Inflammation
|
21.3%
45/211 • Number of events 61 • 5 Years
|
|
Metabolism and nutrition disorders
Metabolic Complication
|
3.8%
8/211 • Number of events 8 • 5 Years
|
|
Cardiac disorders
Mitral Regurg. ( 3+ or 4+)
|
0.47%
1/211 • Number of events 1 • 5 Years
|
|
General disorders
Multiple Organ Comp/Failure
|
8.5%
18/211 • Number of events 18 • 5 Years
|
|
Injury, poisoning and procedural complications
Myocardial Damage
|
1.9%
4/211 • Number of events 4 • 5 Years
|
|
Cardiac disorders
Myocardial Infarction
|
7.6%
16/211 • Number of events 18 • 5 Years
|
|
Nervous system disorders
Neurological Event Minor - Not Stroke
|
5.7%
12/211 • Number of events 13 • 5 Years
|
|
Nervous system disorders
Neurological Event Severe - Not Stroke
|
0.47%
1/211 • Number of events 1 • 5 Years
|
|
General disorders
Other
|
27.0%
57/211 • Number of events 95 • 5 Years
|
|
Cardiac disorders
Pericardial Effusion
|
3.3%
7/211 • Number of events 7 • 5 Years
|
|
General disorders
Peripheral Edema
|
0.47%
1/211 • Number of events 1 • 5 Years
|
|
Product Issues
Perivalvular Leak (1+ or 2+)
|
0.47%
1/211 • Number of events 1 • 5 Years
|
|
Product Issues
Perivalvular Leak (3+ or 4+)
|
3.3%
7/211 • Number of events 7 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
4.3%
9/211 • Number of events 11 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.47%
1/211 • Number of events 1 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.9%
4/211 • Number of events 4 • 5 Years
|
|
Renal and urinary disorders
Renal Comp / Failure Not Requiring Dialysis
|
8.5%
18/211 • Number of events 20 • 5 Years
|
|
Renal and urinary disorders
Renal Failure Requiring Dialysis
|
5.7%
12/211 • Number of events 13 • 5 Years
|
|
Surgical and medical procedures
Reoperation
|
2.4%
5/211 • Number of events 5 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Comp / Failure
|
13.3%
28/211 • Number of events 38 • 5 Years
|
|
Infections and infestations
Sepsis
|
4.7%
10/211 • Number of events 10 • 5 Years
|
|
Nervous system disorders
Stroke - Bleeding Origin
|
0.47%
1/211 • Number of events 1 • 5 Years
|
|
Nervous system disorders
Stroke - Embolic Origin
|
4.7%
10/211 • Number of events 10 • 5 Years
|
|
Nervous system disorders
Stroke - Unknown Origin
|
2.4%
5/211 • Number of events 5 • 5 Years
|
|
General disorders
Sudden Death
|
9.0%
19/211 • Number of events 19 • 5 Years
|
|
Psychiatric disorders
Suicide
|
0.47%
1/211 • Number of events 1 • 5 Years
|
|
Injury, poisoning and procedural complications
Surgical Bleeding
|
4.3%
9/211 • Number of events 9 • 5 Years
|
|
Nervous system disorders
Syncope
|
4.3%
9/211 • Number of events 12 • 5 Years
|
|
Vascular disorders
Thromboembolic Event Minor - Not Stroke
|
0.47%
1/211 • Number of events 1 • 5 Years
|
|
Vascular disorders
Thrombus
|
0.47%
1/211 • Number of events 1 • 5 Years
|
|
Psychiatric disorders
Transitory Psychotic Syndrome
|
0.95%
2/211 • Number of events 2 • 5 Years
|
|
Cardiac disorders
Tricuspid Regurg. ( 3+ or 4+)
|
0.47%
1/211 • Number of events 1 • 5 Years
|
|
Infections and infestations
Urinary Tract Infection
|
2.4%
5/211 • Number of events 6 • 5 Years
|
|
General disorders
Valve Embolization
|
0.47%
1/211 • Number of events 1 • 5 Years
|
|
Injury, poisoning and procedural complications
Valve Malpositioned
|
1.4%
3/211 • Number of events 3 • 5 Years
|
|
Product Issues
Valve Migration
|
0.95%
2/211 • Number of events 2 • 5 Years
|
|
Injury, poisoning and procedural complications
Vascular Access-Related Complication
|
11.4%
24/211 • Number of events 26 • 5 Years
|
|
Vascular disorders
Vascular Complication (Not Access-Related)
|
6.2%
13/211 • Number of events 32 • 5 Years
|
|
Eye disorders
Vision Disorder
|
0.47%
1/211 • Number of events 1 • 5 Years
|
Other adverse events
| Measure |
TAVR
n=211 participants at risk
Transaortic Valve Replacement
Sapien XT™ transcatheter heart valve and delivery system
|
|---|---|
|
Cardiac disorders
Arrhythmia w/o Pacemaker Implant
|
27.5%
58/211 • Number of events 66 • 5 Years
|
|
Vascular disorders
Bleeding Event Minor - Not Surgical
|
19.9%
42/211 • Number of events 49 • 5 Years
|
|
Blood and lymphatic system disorders
Coagulopathy / Hematological Disorder
|
24.2%
51/211 • Number of events 58 • 5 Years
|
|
Cardiac disorders
Ecg Changes
|
9.0%
19/211 • Number of events 22 • 5 Years
|
|
General disorders
Fever Unknown Origin
|
5.2%
11/211 • Number of events 11 • 5 Years
|
|
Gastrointestinal disorders
Gastro-Intestinal Compl
|
13.7%
29/211 • Number of events 37 • 5 Years
|
|
Cardiac disorders
Heart Failure
|
15.2%
32/211 • Number of events 36 • 5 Years
|
|
Vascular disorders
Hypertension
|
7.6%
16/211 • Number of events 19 • 5 Years
|
|
Vascular disorders
Hypotension
|
7.1%
15/211 • Number of events 15 • 5 Years
|
|
Infections and infestations
Infection / Inflammation
|
34.1%
72/211 • Number of events 93 • 5 Years
|
|
Metabolism and nutrition disorders
Metabolic Complication
|
13.7%
29/211 • Number of events 40 • 5 Years
|
|
Nervous system disorders
Neurological Event Minor - Not Stroke
|
19.4%
41/211 • Number of events 50 • 5 Years
|
|
General disorders
Other
|
49.8%
105/211 • Number of events 217 • 5 Years
|
|
General disorders
Peripheral Edema
|
10.0%
21/211 • Number of events 25 • 5 Years
|
|
Product Issues
Perivalvular Leak (1+ or 2+)
|
10.0%
21/211 • Number of events 21 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
15.2%
32/211 • Number of events 38 • 5 Years
|
|
Renal and urinary disorders
Renal Comp / Failure Not Requiring Dialysis
|
15.2%
32/211 • Number of events 38 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Comp / Failure
|
10.0%
21/211 • Number of events 23 • 5 Years
|
|
Psychiatric disorders
Transitory Psychotic Syndrome
|
9.0%
19/211 • Number of events 20 • 5 Years
|
|
Infections and infestations
Urinary Tract Infection
|
11.8%
25/211 • Number of events 36 • 5 Years
|
|
Injury, poisoning and procedural complications
Vascular Access-Related Complication
|
13.7%
29/211 • Number of events 33 • 5 Years
|
|
Eye disorders
Vision Disorder
|
5.2%
11/211 • Number of events 11 • 5 Years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place