Trial Outcomes & Findings for FlexNav EU CE Mark Study (NCT NCT03724812)
NCT ID: NCT03724812
Last Updated: 2021-11-24
Results Overview
Percentage of patients with a VARC-2 defined major vascular complication event
COMPLETED
NA
46 participants
At 30 days post index procedure
2021-11-24
Participant Flow
Patients were enrolled between 26 February 2019 and 10 December 2019
Participant milestones
| Measure |
Portico Valve and FlexNav™ Delivery System
Subjects will undergo an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and next-generation FlexNav Delivery system via a transfemoral access approach
|
|---|---|
|
Overall Study
STARTED
|
46
|
|
Overall Study
Discharge
|
46
|
|
Overall Study
30 Day Follow-Up
|
45
|
|
Overall Study
6 Month Follow-Up
|
42
|
|
Overall Study
12-Month Follow-Up
|
42
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Portico Valve and FlexNav™ Delivery System
Subjects will undergo an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and next-generation FlexNav Delivery system via a transfemoral access approach
|
|---|---|
|
Overall Study
Missed Visit
|
1
|
|
Overall Study
Death
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Portico Valve and FlexNav™ Delivery System
n=46 Participants
Subjects will undergo an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and next-generation FlexNav Delivery system via a transfemoral access approach
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=46 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=46 Participants
|
|
Age, Categorical
>=65 years
|
46 Participants
n=46 Participants
|
|
Age, Continuous
|
85.4 years
STANDARD_DEVIATION 4.9 • n=46 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=46 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=46 Participants
|
|
Region of Enrollment
Denmark
|
3 participants
n=46 Participants
|
|
Region of Enrollment
Italy
|
17 participants
n=46 Participants
|
|
Region of Enrollment
United Kingdom
|
22 participants
n=46 Participants
|
|
Region of Enrollment
Switzerland
|
4 participants
n=46 Participants
|
PRIMARY outcome
Timeframe: At 30 days post index procedurePopulation: Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects)
Percentage of patients with a VARC-2 defined major vascular complication event
Outcome measures
| Measure |
Portico Valve and FlexNav™ Delivery System
n=46 Participants
Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
|
|---|---|
|
Major Vascular Complications
|
4.3 percentage of participants
Interval 0.5 to 14.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days from the index procedure.Population: Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects)
Percentage of patients with a non-hierarchical composite endpoint of all-cause mortality, disabling stroke, life threatening bleeding requiring blood transfusion, acute kidney injury requiring dialysis, or major vascular complications
Outcome measures
| Measure |
Portico Valve and FlexNav™ Delivery System
n=46 Participants
Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
|
|---|---|
|
Non-hierarchical Composite Safety Endpoint
|
6.5 percentage of subjects
Interval 1.37 to 17.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days from the index procedurePopulation: Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects)
Percentage of patients with VARC 2 defined all-cause mortality
Outcome measures
| Measure |
Portico Valve and FlexNav™ Delivery System
n=46 Participants
Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
|
|---|---|
|
All-Cause Mortality
|
0 percentage of participants
Interval 0.0 to 7.71
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days from index procedurePopulation: Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects)
Percentage of patients with a VARC-2 defined disabling stroke event
Outcome measures
| Measure |
Portico Valve and FlexNav™ Delivery System
n=46 Participants
Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
|
|---|---|
|
Disabling Stroke
|
0 percentage of participants
Interval 0.0 to 7.71
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days from the index procedurePopulation: Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects)
Percentage of patients with a VARC-2 defined life-threatening bleeding event requiring blood transfusion
Outcome measures
| Measure |
Portico Valve and FlexNav™ Delivery System
n=46 Participants
Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
|
|---|---|
|
Life-threatening Bleeding Requiring Blood Transfusion
|
4.3 percentage of participants
Interval 0.53 to 14.84
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days from index procedurePopulation: Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects)
Percentage of patients with VARC 2 defined major bleeding event
Outcome measures
| Measure |
Portico Valve and FlexNav™ Delivery System
n=46 Participants
Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
|
|---|---|
|
Major Bleeding Event
|
4.3 percentage of participants
Interval 0.53 to 14.84
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days from index procedurePopulation: Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects)
Percentage of patients with a VARC 2 defined acute kidney injury event
Outcome measures
| Measure |
Portico Valve and FlexNav™ Delivery System
n=46 Participants
Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
|
|---|---|
|
Acute Kidney Injury
|
0 percentage of participants
Interval 0.0 to 7.71
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days from index procedurePopulation: Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects)
Percentage of patients with a VARC-2 defined minor vascular complication
Outcome measures
| Measure |
Portico Valve and FlexNav™ Delivery System
n=46 Participants
Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
|
|---|---|
|
Minor Vascular Complication
|
15.2 percentage of participants
Interval 6.34 to 28.87
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days from index procedurePopulation: Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects) and who did not have a pre-existing pacemaker at baseline.
Percentage of patients requiring a new permanent pacemaker. Excludes patients with a pre-existing permanent pacemaker at baseline
Outcome measures
| Measure |
Portico Valve and FlexNav™ Delivery System
n=42 Participants
Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
|
|---|---|
|
New Permanent Pacemaker Implant
|
14.3 percentage of participants
Interval 5.43 to 28.54
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days from index procedurePopulation: Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects) with an analyzable echocardiogram at 30 days
Echocardiographic core-laboratory derived severity of paravalvular leak
Outcome measures
| Measure |
Portico Valve and FlexNav™ Delivery System
n=43 Participants
Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
|
|---|---|
|
Severity of Paravalvular Leak
None/Trace/Trivial PVL
|
53.5 percentage of patients
|
|
Severity of Paravalvular Leak
Mild PVL
|
46.5 percentage of patients
|
|
Severity of Paravalvular Leak
Moderate PVL
|
0 percentage of patients
|
|
Severity of Paravalvular Leak
Severe PVL
|
0 percentage of patients
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days from index procedurePopulation: Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects). Information was not available for one subject.
Proportion of subjects with a NYHA Functional Class of I,II, III or IV (range I-IV where a lower score indicates less limitation in physical activity)
Outcome measures
| Measure |
Portico Valve and FlexNav™ Delivery System
n=45 Participants
Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
|
|---|---|
|
NYHA Functional Classification
NYHA I
|
48.9 percentage of participants
|
|
NYHA Functional Classification
NYHA II
|
48.9 percentage of participants
|
|
NYHA Functional Classification
NYHA III
|
2.2 percentage of participants
|
|
NYHA Functional Classification
NYHA IV
|
0 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days from index procedurePopulation: Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects). Information was not available for 2 subjects.
KCCQ Overall summary score (range 0-100 where a higher score indicates a better quality of life and physical function)
Outcome measures
| Measure |
Portico Valve and FlexNav™ Delivery System
n=44 Participants
Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
|
|---|---|
|
Kansas City Cardiomyopathy Questionnaire Quality of Life (QOL) Score
|
66.46 score on a scale
Standard Deviation 20.86
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Over the duration of index procedure, an average of 60.6 minutesPopulation: Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects)
Technical device success defined as successful vascular access, delivery and deployment of the Portico Valve; retrieval with the delivery system and correct positioning of a single valve in the proper anatomical location.
Outcome measures
| Measure |
Portico Valve and FlexNav™ Delivery System
n=46 Participants
Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
|
|---|---|
|
Technical Device Success
|
100 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: One year (365 days) from index procedurePopulation: sensitivity analyses censoring subject's first COVID-19 related endpoint event
Percentage of patients with a composite of all-cause mortality or disabling stroke at one year from the index procedure censored for COVID-19 related events
Outcome measures
| Measure |
Portico Valve and FlexNav™ Delivery System
n=46 Participants
Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
|
|---|---|
|
All-Cause Mortality or Disabling Stroke
|
2.2 percentage of participants
Interval 0.32 to 14.75
|
OTHER_PRE_SPECIFIED outcome
Timeframe: One year (365 days) from index procedurePopulation: sensitivity analyses censoring subject's first COVID-19 related endpoint event
Percentage of patients that died at one year from the index procedure censored for COVID-19 related endpoint events
Outcome measures
| Measure |
Portico Valve and FlexNav™ Delivery System
n=46 Participants
Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
|
|---|---|
|
All-Cause Mortality
|
2.2 percentage of participants
Interval 0.32 to 14.75
|
OTHER_PRE_SPECIFIED outcome
Timeframe: One Year (365 days) from index procedurePopulation: sensitivity analyses censoring subject's first COVID-19 related endpoint event
Percentage of patients with a disabling stroke at one year from index procedure censored for COVID-19 related endpoint events
Outcome measures
| Measure |
Portico Valve and FlexNav™ Delivery System
n=46 Participants
Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
|
|---|---|
|
Disabling Stroke
|
0 percentage of participants
Interval 0.0 to 0.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: One year from index procedurePopulation: Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects) with an analyzable echocardiogram at 30 days
Echocardiographic core-laboratory derived severity of paravalvular leak
Outcome measures
| Measure |
Portico Valve and FlexNav™ Delivery System
n=36 Participants
Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
|
|---|---|
|
Severity of Paravalvular Leak
None/Trace/Trivial PVL
|
72.2 percentage of patients
|
|
Severity of Paravalvular Leak
Mild PVL
|
27.8 percentage of patients
|
|
Severity of Paravalvular Leak
Moderate PVL
|
0.0 percentage of patients
|
|
Severity of Paravalvular Leak
Severe PVL
|
0.0 percentage of patients
|
OTHER_PRE_SPECIFIED outcome
Timeframe: One year from index procedurePopulation: Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects). Information was not available for one subject.
Proportion of subjects with a NYHA Functional Class of I,II, III or IV (range I-IV where a lower score indicates less limitation in physical activity)
Outcome measures
| Measure |
Portico Valve and FlexNav™ Delivery System
n=40 Participants
Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
|
|---|---|
|
NYHA Functional Classification
NYHA I
|
57.5 percentage of participants
|
|
NYHA Functional Classification
NYHA II
|
40.0 percentage of participants
|
|
NYHA Functional Classification
NYHA III
|
2.5 percentage of participants
|
|
NYHA Functional Classification
NYHA IV
|
0.0 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: One year from index procedurePopulation: Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects). Information was not available for 2 subjects.
KCCQ Overall summary score (range 0-100 where a higher score indicates a better quality of life and physical function)
Outcome measures
| Measure |
Portico Valve and FlexNav™ Delivery System
n=40 Participants
Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
|
|---|---|
|
Kansas City Cardiomyopathy Questionnaire Quality of Life (QOL) Score
|
71.11 score on a scale
Standard Deviation 16.71
|
Adverse Events
Portico Valve and FlexNav™ Delivery System
Serious adverse events
| Measure |
Portico Valve and FlexNav™ Delivery System
n=46 participants at risk
Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
|
|---|---|
|
Cardiac disorders
Arrhythmias
|
6.5%
3/46 • Number of events 4 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Cardiac disorders
Endocarditis
|
2.2%
1/46 • Number of events 2 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Cardiac disorders
Cardiac Arrest
|
2.2%
1/46 • Number of events 1 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Cardiac disorders
Pericardial Effusion
|
2.2%
1/46 • Number of events 1 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Cardiac disorders
Pericardial Tamponade
|
2.2%
1/46 • Number of events 1 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Cardiac disorders
Heart Block
|
10.9%
5/46 • Number of events 5 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Cardiac disorders
Heart Failure
|
10.9%
5/46 • Number of events 6 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Blood and lymphatic system disorders
Anemia
|
4.3%
2/46 • Number of events 2 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Infections and infestations
Bacterial Infection
|
4.3%
2/46 • Number of events 3 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
General disorders
General
|
21.7%
10/46 • Number of events 12 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Nervous system disorders
Stroke
|
4.3%
2/46 • Number of events 2 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Injury, poisoning and procedural complications
Vascular Access Site Complications
|
4.3%
2/46 • Number of events 2 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Cardiac disorders
Coronary Artery Disease
|
2.2%
1/46 • Number of events 1 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Gastrointestinal disorders
Pancreatitis
|
2.2%
1/46 • Number of events 1 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Renal and urinary disorders
Urinary Tract Infection
|
2.2%
1/46 • Number of events 1 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
General disorders
Bleeding
|
2.2%
1/46 • Number of events 1 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
4.3%
2/46 • Number of events 2 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Musculoskeletal and connective tissue disorders
General-Musculoskeletal Symptoms
|
2.2%
1/46 • Number of events 1 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Nervous system disorders
Syncope
|
2.2%
1/46 • Number of events 3 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Nervous system disorders
Seizure/Convulsions/Epilepsy
|
2.2%
1/46 • Number of events 1 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.3%
2/46 • Number of events 2 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.3%
2/46 • Number of events 2 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
Other adverse events
| Measure |
Portico Valve and FlexNav™ Delivery System
n=46 participants at risk
Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
|
|---|---|
|
Cardiac disorders
Arrhythmias
|
8.7%
4/46 • Number of events 4 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Cardiac disorders
Arterial Hypertension
|
2.2%
1/46 • Number of events 1 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Cardiac disorders
Heart Block
|
21.7%
10/46 • Number of events 10 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.2%
1/46 • Number of events 1 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Blood and lymphatic system disorders
Anemias
|
10.9%
5/46 • Number of events 5 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Blood and lymphatic system disorders
Bleeding
|
2.2%
1/46 • Number of events 1 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Blood and lymphatic system disorders
Hematoma
|
4.3%
2/46 • Number of events 2 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.2%
1/46 • Number of events 1 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
General disorders
Allergy
|
2.2%
1/46 • Number of events 1 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
General disorders
Other
|
15.2%
7/46 • Number of events 10 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
General disorders
Dental Disorders
|
2.2%
1/46 • Number of events 1 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Endocrine disorders
Thyroid Disorders
|
2.2%
1/46 • Number of events 1 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Renal and urinary disorders
Edema
|
2.2%
1/46 • Number of events 1 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Renal and urinary disorders
Urinary Tract Infection
|
2.2%
1/46 • Number of events 1 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
|
Product Issues
Aortic Valve Regurgitation/Aortic Valve Insufficiency/Valvular Regurgitation Aortic Valve
|
2.2%
1/46 • Number of events 1 • Site-reported adverse events related to the investigational study device within 1 year follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place