Trial Outcomes & Findings for PREVAIL-J - Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Japan) (NCT NCT01113983)
NCT ID: NCT01113983
Last Updated: 2020-05-01
Results Overview
Improvement of the aortic valve area (AVA) and New York Heart Association (NYHA) functional classification from baseline to 6 months 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 6 months \> 1.0 cm2 indicates improvement. This outcome measure shows the percentage of patients that had an improvement in both NYHA Class and AVA.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
6 Months
Results posted on
2020-05-01
Participant Flow
Participant milestones
| Measure |
TAVI - TF Approach
Transcatheter aortic valve implantation and transfemoral approach
Transcatheter aortic valve implantation: Transcatheter aortic valve implantation via transapical and transfemoral approach
|
TAVI-TA Approach
Transcatheter aortic valve implantation - Transapical approach
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
27
|
|
Overall Study
COMPLETED
|
12
|
10
|
|
Overall Study
NOT COMPLETED
|
25
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PREVAIL-J - Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Japan)
Baseline characteristics by cohort
| Measure |
TAVI - TF Approach
n=37 Participants
Transcatheter aortic valve implantation and transfemoral approach
Transcatheter aortic valve implantation: Transcatheter aortic valve implantation via transapical or transfemoral approach
|
TAVI-TA Approach
n=27 Participants
Transcatheter aortic valve implantation - Transapical approach
Transcatheter aortic valve implantation: Transcatheter aortic valve implantation via transapical or transfemoral approach
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
83.2 Years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
85.9 Years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
84.3 Years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Height
|
151.10 cm
STANDARD_DEVIATION 7.82 • n=5 Participants
|
147.47 cm
STANDARD_DEVIATION 8.55 • n=7 Participants
|
149.57 cm
STANDARD_DEVIATION 8.27 • n=5 Participants
|
|
NYHA III/IV
|
40.5 % of participants
n=5 Participants
|
48.1 % of participants
n=7 Participants
|
43.8 % of participants
n=5 Participants
|
|
NYHA II
|
59.5 % of Patients
n=5 Participants
|
51.9 % of Patients
n=7 Participants
|
56.3 % of Patients
n=5 Participants
|
|
Arrhythmia
|
56.8 % of patricipants
n=5 Participants
|
37.0 % of patricipants
n=7 Participants
|
48.4 % of patricipants
n=5 Participants
|
|
Porcelain Aorta
|
13.5 % of Participants
n=5 Participants
|
22.2 % of Participants
n=7 Participants
|
17.2 % of Participants
n=5 Participants
|
|
Renal Disease
|
24.3 % of Participants
n=5 Participants
|
44.4 % of Participants
n=7 Participants
|
32.8 % of Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsImprovement of the aortic valve area (AVA) and New York Heart Association (NYHA) functional classification from baseline to 6 months 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 6 months \> 1.0 cm2 indicates improvement. This outcome measure shows the percentage of patients that had an improvement in both NYHA Class and AVA.
Outcome measures
| Measure |
TAVI - TF Approach
n=37 Participants
Transcatheter aortic valve implantation and transfemoral approach
Transcatheter aortic valve implantation: Transcatheter aortic valve implantation via transapical or transfemoral approach
|
TAVI-TA Approach
n=27 Participants
Transcatheter aortic valve implantation - Transapical approach
Transcatheter aortic valve implantation: Transcatheter aortic valve implantation via transapical or transfemoral approach
|
|---|---|---|
|
Improvement of the AVA and NYHA Functional Classification
|
38.2 % of participants
|
45.8 % of participants
|
SECONDARY outcome
Timeframe: 6 monthsDeath Adverse Event Rate
Outcome measures
| Measure |
TAVI - TF Approach
n=37 Participants
Transcatheter aortic valve implantation and transfemoral approach
Transcatheter aortic valve implantation: Transcatheter aortic valve implantation via transapical or transfemoral approach
|
TAVI-TA Approach
n=27 Participants
Transcatheter aortic valve implantation - Transapical approach
Transcatheter aortic valve implantation: Transcatheter aortic valve implantation via transapical or transfemoral approach
|
|---|---|---|
|
Death
|
5.4 percentage of participants
|
18.5 percentage of participants
|
Adverse Events
TAVI - TF Approach
Serious events: 25 serious events
Other events: 19 other events
Deaths: 2 deaths
TAVI-TA Approach
Serious events: 27 serious events
Other events: 13 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
TAVI - TF Approach
n=37 participants at risk
Transcatheter aortic valve implantation and transfemoral approach
Transcatheter aortic valve implantation: Transcatheter aortic valve implantation via transapical or transfemoral approach
|
TAVI-TA Approach
n=27 participants at risk
Transcatheter aortic valve implantation - Transapical approach
Transcatheter aortic valve implantation: Transcatheter aortic valve implantation via transapical or transfemoral approach
|
|---|---|---|
|
Endocrine disorders
Acute adrenocortical insufficiency
|
2.7%
1/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Surgical and medical procedures
Aortic Valve Replacement
|
0.00%
0/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Cardiac disorders
Complete atrioventricular block
|
5.4%
2/37 • 6 Months
|
22.2%
6/27 • 6 Months
|
|
Cardiac disorders
Heart failure
|
2.7%
1/37 • 6 Months
|
11.1%
3/27 • 6 Months
|
|
Cardiac disorders
Cardiac tamponade
|
2.7%
1/37 • 6 Months
|
0.00%
0/27 • 6 Months
|
|
Cardiac disorders
Cardiopulmonary arrest
|
5.4%
2/37 • 6 Months
|
0.00%
0/27 • 6 Months
|
|
Vascular disorders
Cerebral infarction
|
2.7%
1/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Infections and infestations
Suppurative cholangitis
|
0.00%
0/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Cardiac disorders
Coronary occlusion
|
0.00%
0/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Cardiac disorders
Coronary stenosis
|
0.00%
0/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
2.7%
1/37 • 6 Months
|
0.00%
0/27 • 6 Months
|
|
Hepatobiliary disorders
Hepatic dysfunction
|
2.7%
1/37 • 6 Months
|
0.00%
0/27 • 6 Months
|
|
Infections and infestations
Infection
|
2.7%
1/37 • 6 Months
|
0.00%
0/27 • 6 Months
|
|
Infections and infestations
Mastitis
|
0.00%
0/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
General disorders
Peripheral edema
|
0.00%
0/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.7%
1/37 • 6 Months
|
7.4%
2/27 • 6 Months
|
|
Infections and infestations
Pneumonia
|
2.7%
1/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Cardiac disorders
Sick sinus syndrome
|
2.7%
1/37 • 6 Months
|
0.00%
0/27 • 6 Months
|
|
Vascular disorders
Hemorrhoid bleeding
|
5.4%
2/37 • 6 Months
|
11.1%
3/27 • 6 Months
|
|
Vascular disorders
Bleeding
|
5.4%
2/37 • 6 Months
|
11.1%
3/27 • 6 Months
|
|
Injury, poisoning and procedural complications
Aortic rupture
|
2.7%
1/37 • 6 Months
|
0.00%
0/27 • 6 Months
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airway disorder
|
2.7%
1/37 • 6 Months
|
0.00%
0/27 • 6 Months
|
|
Surgical and medical procedures
Tooth extraction
|
2.7%
1/37 • 6 Months
|
0.00%
0/27 • 6 Months
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Renal and urinary disorders
Renal dysfunction
|
2.7%
1/37 • 6 Months
|
0.00%
0/27 • 6 Months
|
|
Infections and infestations
Sepsis
|
0.00%
0/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
General disorders
Disuse syndrome
|
2.7%
1/37 • 6 Months
|
0.00%
0/27 • 6 Months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Nervous system disorders
Rotatory vertigo
|
0.00%
0/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Surgical and medical procedures
Study valve dislodge from aortic annulus
|
2.7%
1/37 • 6 Months
|
0.00%
0/27 • 6 Months
|
|
Surgical and medical procedures
Balloon contractile dysfunction
|
2.7%
1/37 • 6 Months
|
0.00%
0/27 • 6 Months
|
Other adverse events
| Measure |
TAVI - TF Approach
n=37 participants at risk
Transcatheter aortic valve implantation and transfemoral approach
Transcatheter aortic valve implantation: Transcatheter aortic valve implantation via transapical or transfemoral approach
|
TAVI-TA Approach
n=27 participants at risk
Transcatheter aortic valve implantation - Transapical approach
Transcatheter aortic valve implantation: Transcatheter aortic valve implantation via transapical or transfemoral approach
|
|---|---|---|
|
Hepatobiliary disorders
Hepatic dysfunction
|
10.8%
4/37 • 6 Months
|
0.00%
0/27 • 6 Months
|
|
Musculoskeletal and connective tissue disorders
Contusion
|
2.7%
1/37 • 6 Months
|
0.00%
0/27 • 6 Months
|
|
Renal and urinary disorders
Diabetic nephropathy
|
2.7%
1/37 • 6 Months
|
0.00%
0/27 • 6 Months
|
|
Renal and urinary disorders
Renal dysfunction
|
2.7%
1/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
General disorders
Peripheral edema
|
2.7%
1/37 • 6 Months
|
0.00%
0/27 • 6 Months
|
|
General disorders
Pain
|
2.7%
1/37 • 6 Months
|
0.00%
0/27 • 6 Months
|
|
General disorders
Fever
|
2.7%
1/37 • 6 Months
|
0.00%
0/27 • 6 Months
|
|
General disorders
General health decline
|
2.7%
1/37 • 6 Months
|
0.00%
0/27 • 6 Months
|
|
Investigations
Elevation of CPK in blood
|
0.00%
0/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Infections and infestations
Cystitis
|
2.7%
1/37 • 6 Months
|
0.00%
0/27 • 6 Months
|
|
Infections and infestations
Nasopharyngitis
|
2.7%
1/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Infections and infestations
Pseudomembranous colitis
|
2.7%
1/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Infections and infestations
Urinary tract infection
|
2.7%
1/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vocal cord polyp
|
0.00%
0/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Blood and lymphatic system disorders
Anemia
|
2.7%
1/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.7%
1/37 • 6 Months
|
0.00%
0/27 • 6 Months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
21.6%
8/37 • 6 Months
|
40.7%
11/27 • 6 Months
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.00%
0/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Nervous system disorders
Dysgeusia
|
2.7%
1/37 • 6 Months
|
0.00%
0/27 • 6 Months
|
|
Ear and labyrinth disorders
Meniere's disease
|
21.6%
8/37 • 6 Months
|
7.4%
2/27 • 6 Months
|
|
Cardiac disorders
Aortic regurgitation
|
2.7%
1/37 • 6 Months
|
29.6%
8/27 • 6 Months
|
|
Cardiac disorders
Atrial fibrillation
|
2.7%
1/37 • 6 Months
|
7.4%
2/27 • 6 Months
|
|
Cardiac disorders
Atrioventricular block
|
2.7%
1/37 • 6 Months
|
0.00%
0/27 • 6 Months
|
|
Cardiac disorders
Complete atrioventricular block
|
0.00%
0/37 • 6 Months
|
7.4%
2/27 • 6 Months
|
|
Cardiac disorders
Left bundle branch block
|
8.1%
3/37 • 6 Months
|
7.4%
2/27 • 6 Months
|
|
Cardiac disorders
Right bundle branch block
|
0.00%
0/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Cardiac disorders
Heart failure
|
2.7%
1/37 • 6 Months
|
7.4%
2/27 • 6 Months
|
|
Cardiac disorders
Congestive heart failure
|
2.7%
1/37 • 6 Months
|
0.00%
0/27 • 6 Months
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Cardiac disorders
Pulmonary congestion
|
2.7%
1/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Cardiac disorders
Tricuspid regurgitation
|
0.00%
0/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Cardiac disorders
Ventricular premature complex
|
2.7%
1/37 • 6 Months
|
0.00%
0/27 • 6 Months
|
|
Cardiac disorders
Ventricular tachycardia
|
2.7%
1/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Vascular disorders
Cerebellar infarction
|
0.00%
0/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Vascular disorders
Cerebral infarction
|
2.7%
1/37 • 6 Months
|
11.1%
3/27 • 6 Months
|
|
Vascular disorders
Intraoperative bleeding
|
0.00%
0/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.4%
2/37 • 6 Months
|
11.1%
3/27 • 6 Months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/37 • 6 Months
|
3.7%
1/27 • 6 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place