Trial Outcomes & Findings for ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis (NCT NCT03517436)
NCT ID: NCT03517436
Last Updated: 2025-11-13
Results Overview
Number of participants that died
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
101 participants
Primary outcome timeframe
1 year
Results posted on
2025-11-13
Participant Flow
Participant milestones
| Measure |
Edwards CENTERA System TAVR
Transcatheter aortic valve replacement (TAVR) with the Edwards CENTERA THV System
|
|---|---|
|
Overall Study
STARTED
|
101
|
|
Overall Study
COMPLETED
|
93
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Edwards CENTERA System TAVR
Transcatheter aortic valve replacement (TAVR) with the Edwards CENTERA THV System
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Did not receive study valve.
|
1
|
Baseline Characteristics
ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis
Baseline characteristics by cohort
| Measure |
Edwards CENTERA System TAVR
n=101 Participants
Transcatheter aortic valve replacement (TAVR) with the Edwards CENTERA THV System
|
|---|---|
|
Age, Continuous
|
80.0 years
STANDARD_DEVIATION 6.32 • n=10 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
91 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: All enrolled participants
Number of participants that died
Outcome measures
| Measure |
Edwards CENTERA System TAVR
n=101 Participants
Transcatheter aortic valve replacement (TAVR) with the Edwards CENTERA THV System
|
|---|---|
|
All-cause Death
|
3 Participants
|
Adverse Events
Edwards CENTERA System TAVR
Serious events: 46 serious events
Other events: 44 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Edwards CENTERA System TAVR
n=101 participants at risk
Transcatheter aortic valve replacement (TAVR) with the Edwards CENTERA THV System
|
|---|---|
|
Infections and infestations
Endocarditis bacterial
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Infections and infestations
Pneumonia
|
3.0%
3/101 • Number of events 3 • 1 year
|
|
Infections and infestations
Pneumonia bacterial
|
2.0%
2/101 • Number of events 2 • 1 year
|
|
Infections and infestations
Sepsis
|
0.99%
1/101 • Number of events 2 • 1 year
|
|
Infections and infestations
Staphylococcal infection
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Infections and infestations
Urosepsis
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
2.0%
2/101 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Investigations
Troponin increased
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.0%
2/101 • Number of events 3 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic lymphoma
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Nervous system disorders
Carotid artery stenosis
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Nervous system disorders
Cerebrovascular accident
|
2.0%
2/101 • Number of events 2 • 1 year
|
|
Nervous system disorders
Intracranial mass
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Nervous system disorders
Ischaemic stroke
|
3.0%
3/101 • Number of events 3 • 1 year
|
|
Nervous system disorders
Loss of consciousness
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Nervous system disorders
Seizure
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Nervous system disorders
Syncope
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Nervous system disorders
Thalamic infarction
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Nervous system disorders
Transient ischaemic attack
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Product Issues
Device delivery system issue
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Mental status changes
|
2.0%
2/101 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Acute kidney injury
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Urinary retention
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.0%
2/101 • Number of events 2 • 1 year
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Vascular disorders
Femoral artery dissection
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Vascular disorders
Haematoma
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypotension
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Vascular disorders
Peripheral artery occlusion
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac failure congestive
|
2.0%
2/101 • Number of events 2 • 1 year
|
|
Cardiac disorders
Cardiac perforation
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac tamponade
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiogenic shock
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Cardiac disorders
Sinus bradycardia
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Cardiac disorders
Sinus node dysfunction
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Cardiac disorders
Ventricular tachycardia
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Eye disorders
Cataract
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.0%
2/101 • Number of events 3 • 1 year
|
|
General disorders
Chest discomfort
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
General disorders
Chest pain
|
2.0%
2/101 • Number of events 2 • 1 year
|
|
General disorders
Death
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
General disorders
Hernia
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.99%
1/101 • Number of events 2 • 1 year
|
|
Infections and infestations
Abdominal wall abscess
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Infections and infestations
Administration site infection
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Infections and infestations
Anal abscess
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Infections and infestations
Bacteraemia
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Infections and infestations
Cellulitis
|
3.0%
3/101 • Number of events 4 • 1 year
|
|
Infections and infestations
Diverticulitis
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
2.0%
2/101 • Number of events 2 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
5.9%
6/101 • Number of events 9 • 1 year
|
|
Cardiac disorders
Atrioventricular block complete
|
10.9%
11/101 • Number of events 11 • 1 year
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Cardiac disorders
Bradycardia
|
3.0%
3/101 • Number of events 3 • 1 year
|
|
Cardiac disorders
Bundle branch block left
|
0.99%
1/101 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac failure
|
2.0%
2/101 • Number of events 2 • 1 year
|
|
Cardiac disorders
Cardiac failure acute
|
2.0%
2/101 • Number of events 2 • 1 year
|
Other adverse events
| Measure |
Edwards CENTERA System TAVR
n=101 participants at risk
Transcatheter aortic valve replacement (TAVR) with the Edwards CENTERA THV System
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
9.9%
10/101 • Number of events 11 • 1 year
|
|
Cardiac disorders
Atrioventricular block first degree
|
8.9%
9/101 • Number of events 10 • 1 year
|
|
Cardiac disorders
Bundle branch block left
|
27.7%
28/101 • Number of events 29 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
5.9%
6/101 • Number of events 6 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place