Trial Outcomes & Findings for JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study (NCT NCT02732691)
NCT ID: NCT02732691
Last Updated: 2022-11-22
Results Overview
All-cause mortality rate at 30 Day
Recruitment status
UNKNOWN
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
30 Day
Results posted on
2022-11-22
Participant Flow
Participant milestones
| Measure |
Transcatheter Aortic Valve Replacement (TAVR)
Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.
|
|---|---|
|
Overall Study
STARTED
|
68
|
|
Overall Study
COMPLETED
|
68
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Transcatheter Aortic Valve Replacement (TAVR)
n=68 Participants
Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.
|
|---|---|
|
Age, Continuous
|
83 years
STANDARD_DEVIATION 5 • n=68 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=68 Participants
|
PRIMARY outcome
Timeframe: 30 DayPopulation: Enrolled
All-cause mortality rate at 30 Day
Outcome measures
| Measure |
Transcatheter Aortic Valve Replacement (TAVR)
n=68 Participants
Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.
|
|---|---|
|
All-Cause Mortality
|
2 Participants
|
SECONDARY outcome
Timeframe: 30 DayPeri-procedural and spontaneous myocardial infarction
Outcome measures
| Measure |
Transcatheter Aortic Valve Replacement (TAVR)
n=68 Participants
Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.
|
|---|---|
|
Myocardial Infarction
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 DayNeurological Complications
Outcome measures
| Measure |
Transcatheter Aortic Valve Replacement (TAVR)
n=68 Participants
Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.
|
|---|---|
|
All Stroke/TIA
|
6 Participants
|
SECONDARY outcome
Timeframe: 30 DayLife threatening or major bleeding
Outcome measures
| Measure |
Transcatheter Aortic Valve Replacement (TAVR)
n=68 Participants
Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.
|
|---|---|
|
Major Bleeding
|
4 Participants
|
SECONDARY outcome
Timeframe: 30 DayMajor vascular and bleeding complications
Outcome measures
| Measure |
Transcatheter Aortic Valve Replacement (TAVR)
n=68 Participants
Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.
|
|---|---|
|
Major Vascular Complication
|
5 Participants
|
SECONDARY outcome
Timeframe: 30 DayConduction system injury (defect), including AV block, which may require a permanent pacemaker
Outcome measures
| Measure |
Transcatheter Aortic Valve Replacement (TAVR)
n=68 Participants
Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.
|
|---|---|
|
Conduction Disturbance and Arrhythmias
|
10 Participants
|
SECONDARY outcome
Timeframe: 30 DayNumber of patients who were diagnosed with AKI Stage 2 or 3: AKI Stage 2: Increase in serum creatinine to 200%-299% (2.0%-2.99% increase compared with baseline) OR urine output \<0.5 mL/kg/h for \>12 but \<24 h AKI Stage 3: Increase in serum creatinine to ≥300% (\>3 × increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L) OR urine output \<0.3 ml/kg/h for ≥24 h OR anuria for ≥12 h
Outcome measures
| Measure |
Transcatheter Aortic Valve Replacement (TAVR)
n=68 Participants
Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.
|
|---|---|
|
Acute Kidney Injury (AKI)
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 DayCoronary obstruction post-implant requiring intervention
Outcome measures
| Measure |
Transcatheter Aortic Valve Replacement (TAVR)
n=68 Participants
Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.
|
|---|---|
|
Coronary Obstruction Requiring Intervention
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 DayBacterial endocarditis
Outcome measures
| Measure |
Transcatheter Aortic Valve Replacement (TAVR)
n=68 Participants
Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.
|
|---|---|
|
Endocarditis
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 DayNumber of patients who underwent conversion to open sternotomy during the TAVR procedure secondary to any procedure-related complications
Outcome measures
| Measure |
Transcatheter Aortic Valve Replacement (TAVR)
n=68 Participants
Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.
|
|---|---|
|
Conversion to Surgical Aortic Valve Replacement (SAVR)
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 DayNumber of patients who experienced: Migration: After initial correct positioning, the valve prosthesis moves upwards or downwards, within the aortic annulus from its initial position, with or without consequences Embolization: The valve prosthesis moves during or after deployment such that it loses contact with the aortic annulus Ectopic Valve Deployment: Permanent deployment of the valve prosthesis in a location other than the aortic root
Outcome measures
| Measure |
Transcatheter Aortic Valve Replacement (TAVR)
n=68 Participants
Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.
|
|---|---|
|
THV Malpositioning
|
3 Participants
|
Adverse Events
Transcatheter Aortic Valve Replacement (TAVR)
Serious events: 39 serious events
Other events: 23 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Transcatheter Aortic Valve Replacement (TAVR)
n=68 participants at risk
Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.
|
|---|---|
|
Injury, poisoning and procedural complications
Access Site Disection
|
1.5%
1/68 • 30 day
|
|
Cardiac disorders
Acute Coronary Syndrome
|
1.5%
1/68 • 30 day
|
|
Hepatobiliary disorders
Acute Pancreatitis Secondary To Retained Gallstones
|
1.5%
1/68 • 30 day
|
|
General disorders
Allergic Reaction
|
1.5%
1/68 • 30 day
|
|
Blood and lymphatic system disorders
Anemia
|
1.5%
1/68 • 30 day
|
|
Cardiac disorders
Aortic Rupture
|
1.5%
1/68 • 30 day
|
|
Cardiac disorders
Arrhythmia
|
1.5%
1/68 • 30 day
|
|
Cardiac disorders
Arterial Occlusion
|
2.9%
2/68 • 30 day
|
|
Cardiac disorders
Arterial Occlusive Desease
|
1.5%
1/68 • 30 day
|
|
Hepatobiliary disorders
Bilious Attack
|
1.5%
1/68 • 30 day
|
|
Blood and lymphatic system disorders
Bleeding (Life Threatening/Disabling)
|
1.5%
1/68 • 30 day
|
|
Blood and lymphatic system disorders
Bleeding (Major)
|
4.4%
3/68 • 30 day
|
|
Blood and lymphatic system disorders
Bleeding Complication
|
7.4%
5/68 • 30 day
|
|
Cardiac disorders
Bradycardia
|
1.5%
1/68 • 30 day
|
|
Infections and infestations
Cellulitus
|
1.5%
1/68 • 30 day
|
|
Nervous system disorders
Cerebral Hypoxia Due To Open Heart Surgery. Therefore Cerebral Iscemia Which Was Leading To Death.
|
1.5%
1/68 • 30 day
|
|
Cardiac disorders
Conduction Disturbance
|
7.4%
5/68 • 30 day
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.5%
1/68 • 30 day
|
|
Injury, poisoning and procedural complications
Ectopic Deployment
|
1.5%
1/68 • 30 day
|
|
Respiratory, thoracic and mediastinal disorders
Exacerbation COPD
|
2.9%
2/68 • 30 day
|
|
Respiratory, thoracic and mediastinal disorders
Exacerbation Of COPD
|
1.5%
1/68 • 30 day
|
|
General disorders
Fall Secondary To Postural Hypotension
|
1.5%
1/68 • 30 day
|
|
General disorders
Febrile But No Infection Identified
|
1.5%
1/68 • 30 day
|
|
General disorders
Fluid Overload Secondary To Fludricortisone Use
|
1.5%
1/68 • 30 day
|
|
Gastrointestinal disorders
Gastroenteritis
|
1.5%
1/68 • 30 day
|
|
Gastrointestinal disorders
Gastroenteritis Norovirus
|
1.5%
1/68 • 30 day
|
|
Gastrointestinal disorders
GI Complication
|
4.4%
3/68 • 30 day
|
|
Cardiac disorders
Heart Failure
|
4.4%
3/68 • 30 day
|
|
Injury, poisoning and procedural complications
Hematoma
|
1.5%
1/68 • 30 day
|
|
Vascular disorders
Hypertension
|
2.9%
2/68 • 30 day
|
|
Infections and infestations
Infection/Inflammation
|
1.5%
1/68 • 30 day
|
|
General disorders
INR > 8 And General Weakness
|
1.5%
1/68 • 30 day
|
|
General disorders
Maxillary Fracture (Le-Fort I Fracture)
|
1.5%
1/68 • 30 day
|
|
General disorders
Medication Reaction
|
1.5%
1/68 • 30 day
|
|
General disorders
Multiple Falls Secondary To Medication And Parkinsons
|
1.5%
1/68 • 30 day
|
|
Cardiac disorders
Myocardial Insufficiency
|
1.5%
1/68 • 30 day
|
|
Nervous system disorders
Neurological Event
|
1.5%
1/68 • 30 day
|
|
Infections and infestations
Other Infection
|
11.8%
8/68 • 30 day
|
|
Gastrointestinal disorders
Pancolitis
|
2.9%
2/68 • 30 day
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.9%
2/68 • 30 day
|
|
Infections and infestations
Pneumonia
|
4.4%
3/68 • 30 day
|
|
Injury, poisoning and procedural complications
Premature Valve Deployment
|
1.5%
1/68 • 30 day
|
|
Infections and infestations
Pseudomonas Bacteremia
|
1.5%
1/68 • 30 day
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.5%
1/68 • 30 day
|
|
Injury, poisoning and procedural complications
Recurring Subdural Hematoma
|
1.5%
1/68 • 30 day
|
|
General disorders
Reduced Mobility
|
1.5%
1/68 • 30 day
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.5%
1/68 • 30 day
|
|
Cardiac disorders
Restenosis
|
1.5%
1/68 • 30 day
|
|
Infections and infestations
Sepsis
|
1.5%
1/68 • 30 day
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis/Foraminal Stenosis
|
1.5%
1/68 • 30 day
|
|
Nervous system disorders
Status Epilepticus
|
1.5%
1/68 • 30 day
|
|
Nervous system disorders
Stroke/TIA
|
5.9%
4/68 • 30 day
|
|
Nervous system disorders
Subacute Cerebal Infarct Bilaterally.
|
1.5%
1/68 • 30 day
|
|
Injury, poisoning and procedural complications
Subdural Hematoma
|
1.5%
1/68 • 30 day
|
|
Infections and infestations
Suspected Endocarditis
|
1.5%
1/68 • 30 day
|
|
Nervous system disorders
Syncope
|
1.5%
1/68 • 30 day
|
|
General disorders
Tooth Extraction
|
1.5%
1/68 • 30 day
|
|
Infections and infestations
Urosepsis
|
1.5%
1/68 • 30 day
|
|
Injury, poisoning and procedural complications
Valve Malposition / Ectopic Deployment
|
1.5%
1/68 • 30 day
|
|
Vascular disorders
Vascular Dissection
|
1.5%
1/68 • 30 day
|
|
Cardiac disorders
Worsening Of Atrial Fibrilation
|
1.5%
1/68 • 30 day
|
Other adverse events
| Measure |
Transcatheter Aortic Valve Replacement (TAVR)
n=68 participants at risk
Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.
|
|---|---|
|
Blood and lymphatic system disorders
Bleeding Complication
|
7.4%
5/68 • 30 day
|
|
General disorders
Chest Pain
|
5.9%
4/68 • 30 day
|
|
General disorders
Other
|
25.0%
17/68 • 30 day
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Complication
|
7.4%
5/68 • 30 day
|
Additional Information
Vinny Podichetty, Vice President: Clinical & Med Affairs
JenaValve Technologies Inc.
Phone: 949-767-2110
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place