Trial Outcomes & Findings for PREVAIL-20J - Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial (NCT NCT01419015)
NCT ID: NCT01419015
Last Updated: 2020-08-06
Results Overview
Improvement of the aortic valve area (AVA) and New York Heart Association (NYHA) functional classification from baseline to 1 year after the procedure. NYHA functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I-IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort. The AVA at 1 year \>= 0.65 cm2 indicates improvement. This outcome measure shows the percentage of patients that had an improvement in both NYHA Class and AVA. Note: One patient did not complete a 6-month echo.
COMPLETED
NA
17 participants
1 year
2020-08-06
Participant Flow
Participant milestones
| Measure |
20-mm TF-TAVR
Patients with symptomatic severe aortic stenosis received a 20 mm SAPIEN XT valve through the transfemoral procedure.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
20-mm TF-TAVR
Patients with symptomatic severe aortic stenosis received a 20 mm SAPIEN XT valve through the transfemoral procedure.
|
|---|---|
|
Overall Study
Death
|
2
|
Baseline Characteristics
PREVAIL-20J - Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial
Baseline characteristics by cohort
| Measure |
20-mm TF-TAVR
n=17 Participants
Patients with symptomatic severe aortic stenosis received a 20 mm SAPIEN XT valve through the transfemoral procedure.
|
|---|---|
|
Age, Continuous
|
82.2 Years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
NYHA Class III/IV
|
11 Participants
n=5 Participants
|
|
Porcelain Aorta
|
3 Participants
n=5 Participants
|
|
Diabetes
|
6 Participants
n=5 Participants
|
|
Arrhythmia
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearImprovement of the aortic valve area (AVA) and New York Heart Association (NYHA) functional classification from baseline to 1 year after the procedure. NYHA functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I-IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort. The AVA at 1 year \>= 0.65 cm2 indicates improvement. This outcome measure shows the percentage of patients that had an improvement in both NYHA Class and AVA. Note: One patient did not complete a 6-month echo.
Outcome measures
| Measure |
TAVI-TF Approach
n=16 Participants
Transcatheter aortic valve implantation and transfemoral approach. SAPIEN XT NovaFlex delivery system will be used.
|
|---|---|
|
NYHA Improvement and AVA >= 0.65 cm2
|
14 Participants
|
Adverse Events
TAVI-TF Approach
Serious adverse events
| Measure |
TAVI-TF Approach
n=17 participants at risk
Transcatheter aortic valve implantation and transfemoral approach. SAPIEN XT NovaFlex delivery system will be used.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hemangioma
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
Cardiac disorders
Acute myocardial Infraction
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
Cardiac disorders
Ventricular tachycardia
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
Cardiac disorders
Bradycardia
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Acute renal failure
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
General disorders
Device malposition
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Aortic injury
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Femoral fracture
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Cardiac perforation
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
Nervous system disorders
Spinal Compression Fracture
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
Cardiac disorders
Atrioventricular block complete
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
Cardiac disorders
Cardiac Failure
|
5.9%
1/17 • Number of events 2 • 6 months
|
Other adverse events
| Measure |
TAVI-TF Approach
n=17 participants at risk
Transcatheter aortic valve implantation and transfemoral approach. SAPIEN XT NovaFlex delivery system will be used.
|
|---|---|
|
Infections and infestations
Pneumonia
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
Infections and infestations
Bacteremia
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
Infections and infestations
Cellulitis
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
35.3%
6/17 • Number of events 6 • 6 months
|
|
Immune system disorders
Anaphylactic reaction
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
Nervous system disorders
Cerebral Infraction
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
Nervous system disorders
Dementia
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
Cardiac disorders
Atrial fibrillation
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
Cardiac disorders
Aortic regurgitation
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
Cardiac disorders
Cardiac arrest
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
Vascular disorders
Gingival bleeding
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
Vascular disorders
Peripheral ischemia
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Lower gastrointestinal bleeding
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Cholecystitis
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Subcutaneous hemorrhage
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
Investigations
Increased Intraocular pressure
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
Surgical and medical procedures
Cataract surgery
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Epidermal necrosis
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
General disorders
Left Leg Block
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
Cardiac disorders
Ventricular Extrasystole
|
5.9%
1/17 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place