Trial Outcomes & Findings for PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe) (NCT NCT01238835)

NCT ID: NCT01238835

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: 220 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2020-11-02

Participant Flow

One patient withdrew from the study prior to procedure and one patient did not continue to procedure due to poor health.

Two enrolled subjects did not enter the procedure room.

Participant milestones

Measure	TAVR-TA Transcatheter valve replacement with transapical access SAPIEN XT™ Transapical aortic valve replacement: Transcatheter aortic valve implantation via the transapical approach
Overall Study STARTED	218
Overall Study COMPLETED	82
Overall Study NOT COMPLETED	136

Reasons for withdrawal

Measure	TAVR-TA Transcatheter valve replacement with transapical access SAPIEN XT™ Transapical aortic valve replacement: Transcatheter aortic valve implantation via the transapical approach
Overall Study Death	124
Overall Study Withdrawal by Subject	9
Overall Study Lost to Follow-up	1
Overall Study Site early discontinuation	2

Baseline Characteristics

PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)

Baseline characteristics by cohort

Measure	TAVR-TA n=218 Participants Transcatheter valve replacement with transapical access SAPIEN XT™ Transapical aortic valve replacement: Transcatheter aortic valve implantation via the transapical approach
Age, Continuous	81.2 Years STANDARD_DEVIATION 5.46 • n=5 Participants
Sex: Female, Male Female	65 Participants n=5 Participants
Sex: Female, Male Male	153 Participants n=5 Participants
Logistic EuroSCORE	24.0 Units on a scale STANDARD_DEVIATION 7.27 • n=5 Participants
NYHA Class Class I/II	36 Participants n=5 Participants
NYHA Class Class III/IV	182 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Number of death at 30-days from the index procedure.

Outcome measures

Measure	TAVR-TA n=218 Participants Transcatheter valve replacement with transapical access SAPIEN XT™ Transapical aortic valve replacement: Transcatheter aortic valve implantation via the transapical approach
Number of Deaths	16 Participants

SECONDARY outcome

Timeframe: 30-days

Total Number of Participants with a Stroke.

Outcome measures

Measure	TAVR-TA n=218 Participants Transcatheter valve replacement with transapical access SAPIEN XT™ Transapical aortic valve replacement: Transcatheter aortic valve implantation via the transapical approach
Number of Participants With a Stroke	4 Participants

Adverse Events

TAVR-TA

Serious events: 201 serious events

Other events: 212 other events

Deaths: 124 deaths

Serious adverse events

Measure	TAVR-TA n=218 participants at risk Transcatheter valve replacement with transapical access SAPIEN XT™ Transapical aortic valve replacement: Transcatheter aortic valve implantation via the transapical approach
Injury, poisoning and procedural complications Access Related Complication - Thoracic	1.4% 3/218 • Number of events 3 • 5 Years All adverse events are site reported
Injury, poisoning and procedural complications Access Related Complication - Ventricle	1.4% 3/218 • Number of events 3 • 5 Years All adverse events are site reported
Vascular disorders Aneurysm	0.92% 2/218 • Number of events 2 • 5 Years All adverse events are site reported
Cardiac disorders Angina	4.6% 10/218 • Number of events 10 • 5 Years All adverse events are site reported
Injury, poisoning and procedural complications Annular Dissection	0.46% 1/218 • Number of events 1 • 5 Years All adverse events are site reported
Cardiac disorders Arrhythmia Supraventricular	6.9% 15/218 • Number of events 19 • 5 Years All adverse events are site reported
Cardiac disorders Arrhythmia Ventricular	3.2% 7/218 • Number of events 8 • 5 Years All adverse events are site reported
Vascular disorders Bleeding - Not Trauma Not Procedure	4.6% 10/218 • Number of events 10 • 5 Years All adverse events are site reported
Injury, poisoning and procedural complications Bleeding - Procedure	6.0% 13/218 • Number of events 17 • 5 Years All adverse events are site reported
Injury, poisoning and procedural complications Bleeding - Trauma	2.3% 5/218 • Number of events 5 • 5 Years All adverse events are site reported
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	7.3% 16/218 • Number of events 24 • 5 Years All adverse events are site reported
Blood and lymphatic system disorders Coagulopathy / Hematological Disorder	24.3% 53/218 • Number of events 68 • 5 Years All adverse events are site reported
Cardiac disorders Conduction Defects w/o Permanent Pacemaker	0.46% 1/218 • Number of events 1 • 5 Years All adverse events are site reported
Cardiac disorders Conduction Defects with Permanent Pacemaker	14.7% 32/218 • Number of events 35 • 5 Years All adverse events are site reported
Skin and subcutaneous tissue disorders Decubitus	0.46% 1/218 • Number of events 1 • 5 Years All adverse events are site reported
Product Issues Delivery System Malfunction	0.46% 1/218 • Number of events 1 • 5 Years All adverse events are site reported
General disorders Drug Reaction	0.46% 1/218 • Number of events 1 • 5 Years All adverse events are site reported
Infections and infestations Endocarditis	3.2% 7/218 • Number of events 8 • 5 Years All adverse events are site reported
Gastrointestinal disorders Gastro-Intestinal Event	13.3% 29/218 • Number of events 39 • 5 Years All adverse events are site reported
Cardiac disorders Heart Failure	26.6% 58/218 • Number of events 90 • 5 Years All adverse events are site reported
Vascular disorders Hemodynamic Collapse	7.8% 17/218 • Number of events 18 • 5 Years All adverse events are site reported
Vascular disorders Hypertension	3.2% 7/218 • Number of events 10 • 5 Years All adverse events are site reported
Vascular disorders Hypotension	1.4% 3/218 • Number of events 3 • 5 Years All adverse events are site reported
Infections and infestations Infection / Inflammation	28.4% 62/218 • Number of events 90 • 5 Years All adverse events are site reported
Metabolism and nutrition disorders Metabolic Disorder	2.3% 5/218 • Number of events 5 • 5 Years All adverse events are site reported
Cardiac disorders Mitral Regurg. ( 3+ or 4+)	0.92% 2/218 • Number of events 2 • 5 Years All adverse events are site reported
Injury, poisoning and procedural complications Mitral Valve Compromise	0.46% 1/218 • Number of events 1 • 5 Years All adverse events are site reported
General disorders Multiple Organ Failure	3.7% 8/218 • Number of events 8 • 5 Years All adverse events are site reported
Cardiac disorders Myocardial Infarction	4.6% 10/218 • Number of events 14 • 5 Years All adverse events are site reported
Nervous system disorders Neurological Event Minor - Not Stroke	4.1% 9/218 • Number of events 13 • 5 Years All adverse events are site reported
Nervous system disorders Neurological Event Severe - Not Stroke	4.1% 9/218 • Number of events 10 • 5 Years All adverse events are site reported
General disorders Non-Struct Valve Dysf. (Not PVL)	0.46% 1/218 • Number of events 1 • 5 Years All adverse events are site reported
General disorders Orthopedic Event	7.8% 17/218 • Number of events 23 • 5 Years All adverse events are site reported
General disorders Other	30.7% 67/218 • Number of events 114 • 5 Years All adverse events are site reported
Product Issues Perivalvular Leak (1+ or 2+)	0.46% 1/218 • Number of events 1 • 5 Years All adverse events are site reported
Product Issues Perivalvular Leak (3+ or 4+)	3.2% 7/218 • Number of events 7 • 5 Years All adverse events are site reported
Respiratory, thoracic and mediastinal disorders Pleural Effusion	12.8% 28/218 • Number of events 31 • 5 Years All adverse events are site reported
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.46% 1/218 • Number of events 1 • 5 Years All adverse events are site reported
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.46% 1/218 • Number of events 1 • 5 Years All adverse events are site reported
Renal and urinary disorders Renal Failure requiring Permanent Dialysis (>30d)	0.92% 2/218 • Number of events 2 • 5 Years All adverse events are site reported
Renal and urinary disorders Renal Insufficency not requiring Dialysis	7.8% 17/218 • Number of events 20 • 5 Years All adverse events are site reported
Renal and urinary disorders Renal Insufficiency / Failure requiring Temporary Dialysis (< or = 30d)	8.7% 19/218 • Number of events 21 • 5 Years All adverse events are site reported
Respiratory, thoracic and mediastinal disorders Respiratory Comp / Failure not requ. Resp Assistance	7.8% 17/218 • Number of events 19 • 5 Years All adverse events are site reported
Respiratory, thoracic and mediastinal disorders Respiratory Comp / Failure requ. Resp Assistance	11.5% 25/218 • Number of events 31 • 5 Years All adverse events are site reported
Infections and infestations Sepsis	7.8% 17/218 • Number of events 19 • 5 Years All adverse events are site reported
Nervous system disorders Stroke - Embolic / Ischemic Origin	5.5% 12/218 • Number of events 12 • 5 Years All adverse events are site reported
Nervous system disorders Stroke - Unknown Origin	1.4% 3/218 • Number of events 3 • 5 Years All adverse events are site reported
Injury, poisoning and procedural complications Struct Valve Deterioration (SVD)	0.46% 1/218 • Number of events 1 • 5 Years All adverse events are site reported
General disorders Sudden Death	9.2% 20/218 • Number of events 20 • 5 Years All adverse events are site reported
Nervous system disorders Syncope	3.2% 7/218 • Number of events 9 • 5 Years All adverse events are site reported
Injury, poisoning and procedural complications Thoracic Wound Comp.	2.8% 6/218 • Number of events 8 • 5 Years All adverse events are site reported
Vascular disorders Thrombus	0.46% 1/218 • Number of events 1 • 5 Years All adverse events are site reported
Psychiatric disorders Transitory Psychotic Syndrome	4.1% 9/218 • Number of events 9 • 5 Years All adverse events are site reported
General disorders Valve Embolization	0.46% 1/218 • Number of events 1 • 5 Years All adverse events are site reported
Vascular disorders Vascular Event (Not Access-Related)	7.8% 17/218 • Number of events 27 • 5 Years All adverse events are site reported
Injury, poisoning and procedural complications Ventricular / Myocardial Injury / Perforation	0.46% 1/218 • Number of events 1 • 5 Years All adverse events are site reported
Eye disorders Vision Disorder	1.4% 3/218 • Number of events 6 • 5 Years All adverse events are site reported

Other adverse events

Measure	TAVR-TA n=218 participants at risk Transcatheter valve replacement with transapical access SAPIEN XT™ Transapical aortic valve replacement: Transcatheter aortic valve implantation via the transapical approach
Cardiac disorders Arrhythmia Supraventricular	29.4% 64/218 • Number of events 75 • 5 Years All adverse events are site reported
Injury, poisoning and procedural complications Bleeding - Procedure	5.5% 12/218 • Number of events 12 • 5 Years All adverse events are site reported
Blood and lymphatic system disorders Coagulopathy / Hematological Disorder	15.6% 34/218 • Number of events 38 • 5 Years All adverse events are site reported
Cardiac disorders Conduction Defects w/o Permanent Pacemaker	7.8% 17/218 • Number of events 18 • 5 Years All adverse events are site reported
Gastrointestinal disorders Gastro-Intestinal Event	16.5% 36/218 • Number of events 49 • 5 Years All adverse events are site reported
Cardiac disorders Heart Failure	10.6% 23/218 • Number of events 27 • 5 Years All adverse events are site reported
Vascular disorders Hypertension	6.9% 15/218 • Number of events 16 • 5 Years All adverse events are site reported
Infections and infestations Infection / Inflammation	43.1% 94/218 • Number of events 142 • 5 Years All adverse events are site reported
Metabolism and nutrition disorders Metabolic Disorder	12.4% 27/218 • Number of events 31 • 5 Years All adverse events are site reported
Nervous system disorders Neurological Event Minor - Not Stroke	11.9% 26/218 • Number of events 29 • 5 Years All adverse events are site reported
General disorders Orthopedic Event	7.3% 16/218 • Number of events 17 • 5 Years All adverse events are site reported
General disorders Other	56.0% 122/218 • Number of events 253 • 5 Years All adverse events are site reported
Cardiac disorders Pericardial Effusion	6.0% 13/218 • Number of events 14 • 5 Years All adverse events are site reported
General disorders Peripheral Edema	13.8% 30/218 • Number of events 34 • 5 Years All adverse events are site reported
Respiratory, thoracic and mediastinal disorders Pleural Effusion	59.6% 130/218 • Number of events 143 • 5 Years All adverse events are site reported
Respiratory, thoracic and mediastinal disorders Pneumothorax	8.3% 18/218 • Number of events 18 • 5 Years All adverse events are site reported
Renal and urinary disorders Renal Insufficency not requiring Dialysis	16.5% 36/218 • Number of events 39 • 5 Years All adverse events are site reported
Respiratory, thoracic and mediastinal disorders Respiratory Comp / Failure not requ. Resp Assistance	11.5% 25/218 • Number of events 32 • 5 Years All adverse events are site reported
Psychiatric disorders Transitory Psychotic Syndrome	17.9% 39/218 • Number of events 39 • 5 Years All adverse events are site reported

Additional Information

Edwards THV Clinical Affairs

Edwards Lifesciences

Phone: 949-250-2500

Email: THV_CT.gov@edwards.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place