FlexNav EU CE Mark Study

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03724812
• Collaborator: (none)
• Enrollment: 46
• Locations: 6
• Arm: 1
• Actual Duration (Months): 23.5
• Patients Per Site: 7.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic stenosis patients who are considered of high or extreme risk for surgical aortic valve replacement. Data from the study will be used to support CE Mark of the FlexNav™ Delivery System and Loading System in Europe.

Condition or Disease	Intervention/Treatment	Phase
Symptomatic Severe Aortic Stenosis	Device: Portico Valve and FlexNav™ Delivery System	N/A

Detailed Description

The FlexNav European Union (EU) study will be conducted as a prospective, multi-center, single-arm investigational study.

High or extreme risk patients with symptomatic, severe native aortic stenosis who are determined by an independent subject selection committee to meet eligibility criteria for Portico™ Transcatheter Aortic Heart Valve implantation via a transfemoral access approach will undergo a Portico valve implant using the next-generation FlexNav Delivery System.

Subject data will be collected at screening, baseline, pre-procedure, peri-procedure, post-procedure, discharge, 30 days, 6 months and 1-year from the index procedure.

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Devices under investigation in this clinical investigation include the FlexNav™ Delivery System(s) (18 F and 19 F) and FlexNav™ Loading System(s) (Small and Large), which are both approved for investigational use only. Other devices to be used in the clinical investigation include all four (4) market released Abbott Portico™ valve sizes (23mm, 25mm, 27mm and 29mm).Devices under investigation in this clinical investigation include the FlexNav™ Delivery System(s) (18 F and 19 F) and FlexNav™ Loading System(s) (Small and Large), which are both approved for investigational use only. Other devices to be used in the clinical investigation include all four (4) market released Abbott Portico™ valve sizes (23mm, 25mm, 27mm and 29mm).
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Assessment of the Abbott FlexNav™ Delivery System for Portico Transcatheter Aortic Valve Implantation in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis
• Actual Study Start Date: Feb 26, 2019
• Actual Primary Completion Date: Jan 14, 2020
• Actual Study Completion Date: Feb 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Portico valve and FlexNav™ Delivery System Portico valve implantation with the second-generation FlexNav Delivery system	Device: Portico Valve and FlexNav™ Delivery System; Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Portico valve and second-generation FlexNav Delivery system via a transfemoral access approach

Outcome Measures

Primary Outcome Measures

1. Major Vascular Complications [At 30 days post index procedure]

   Percentage of patients with a VARC-2 defined major vascular complication event

Other Outcome Measures

1. Non-hierarchical Composite Safety Endpoint [30 days from the index procedure.]

   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

2. All-Cause Mortality [30 days from the index procedure]

   Percentage of patients with VARC 2 defined all-cause mortality

3. Disabling Stroke [30 days from index procedure]

   Percentage of patients with a VARC-2 defined disabling stroke event

4. Life-threatening Bleeding Requiring Blood Transfusion [30 days from the index procedure]

   Percentage of patients with a VARC-2 defined life-threatening bleeding event requiring blood transfusion

5. Major Bleeding Event [30 days from index procedure]

   Percentage of patients with VARC 2 defined major bleeding event

6. Acute Kidney Injury [30 days from index procedure]

   Percentage of patients with a VARC 2 defined acute kidney injury event

7. Minor Vascular Complication [30 days from index procedure]

   Percentage of patients with a VARC-2 defined minor vascular complication

8. New Permanent Pacemaker Implant [30 days from index procedure]

   Percentage of patients requiring a new permanent pacemaker. Excludes patients with a pre-existing permanent pacemaker at baseline

9. Severity of Paravalvular Leak [30 days from index procedure]

   Echocardiographic core-laboratory derived severity of paravalvular leak

10. NYHA Functional Classification [30 days from index procedure]

    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)

11. Kansas City Cardiomyopathy Questionnaire Quality of Life (QOL) Score [30 days from index procedure]

    KCCQ Overall summary score (range 0-100 where a higher score indicates a better quality of life and physical function)

12. Technical Device Success [Over the duration of index procedure, an average of 60.6 minutes]

    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.

13. All-Cause Mortality or Disabling Stroke [One year (365 days) from index procedure]

    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

14. All-Cause Mortality [One year (365 days) from index procedure]

    Percentage of patients that died at one year from the index procedure censored for COVID-19 related endpoint events

15. Disabling Stroke [One Year (365 days) from index procedure]

    Percentage of patients with a disabling stroke at one year from index procedure censored for COVID-19 related endpoint events

16. Severity of Paravalvular Leak [One year from index procedure]

    Echocardiographic core-laboratory derived severity of paravalvular leak

17. NYHA Functional Classification [One year from index procedure]

    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)

18. Kansas City Cardiomyopathy Questionnaire Quality of Life (QOL) Score [One year from index procedure]

    KCCQ Overall summary score (range 0-100 where a higher score indicates a better quality of life and physical function)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Candidates for High Risk classification must meet all the following inclusion criteria:

1. Subjects must have co-morbidities such that the local heart team concur the predicted risk of operative mortality is ≥15% or a minimum Society of Thoracic Surgeons (STS) score of 8%.

1. A candidate who does not meet the STS score criteria of ≥ 8% may be included in the study if at least one surgeon in the local heart team concludes and documents the patient's predicted risk of operative mortality is ≥15%. The surgeon's assessment of operative comorbidities (including frailty indices) not captured by the STS score must be documented in the study case report form as well as in the patient medical record.

1. Subject is of legal age or older for consent in the host country.

2. Subject has senile degenerative aortic valve stenosis with echo-derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s or doppler velocity index (DVI) <0.25 and an initial aortic valve area (AVA) of ≤1.0 cm2 (indexed Effective Orifice Area (EOA) ≤ 0.6 cm2/m2). (Qualifying AVA baseline measurement must be within 60 days prior to informed consent).

3. Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II, III, or IV.

4. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.

5. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

6. Subject's aortic annulus is 19-27mm diameter as measured by computed tomography (CT) conducted within 12 months prior to informed consent. If a CT i contraindicated and/or not possible to be obtained for certain subjects, a 3D echo and non-contrast CT of chest and abdomen/pelvis may be accepted.

All candidates for Extreme Risk classification must meet # 2, 3, 4, 5, 6, 7 of the above criteria, and

1. After formal consultation with the local heart team (including at least one surgeon) it is agreed that medical factors preclude the subject from undergoing operation, based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. Specifically, the probability of death or serious, irreversible morbidity should exceed 50%. The local heart teams' consult notes shall specify the medical or anatomic factors leading to that conclusion and include a printout of the calculation of the STS score to additionally identify the risks in these patients.

Exclusion Criteria:

Candidates will be excluded if any of the following conditions are present:

1. Evidence of an acute myocardial infarction (defined as: ST Segment Elevation as evidenced on 12 Lead ECG) within 30 days prior to index procedure.

2. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is noncalcified as verified by echocardiography.

3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+).

4. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to index procedure.

5. Pre-existing prosthetic heart valve or other implant in any valve position, prosthetic ring, severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the LVOT, severe (greater than 3+) mitral insufficiency, or severe mitral stenosis with pulmonary compromise.

6. Blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb < 9 g/dL), thrombocytopenia (platelet count <50,000 cells/mm³).

7. History of bleeding diathesis or coagulopathy.

8. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.

9. Untreated clinically significant coronary artery disease requiring revascularization.

10. Hemodynamic instability requiring inotropic support or mechanical heart assistance.

11. Need for emergency surgery for any reason.

12. Hypertrophic cardiomyopathy with or without obstruction (HOCM).

13. Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% as measured by resting echocardiogram.

14. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.

15. Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure.

16. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media which cannot be adequately premedicated.

17. Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA).

18. Renal insufficiency (creatinine > 3.0 mg/dL) and/or end stage renal disease requiring chronic dialysis.

19. Life expectancy < 12 months from the time of informed consent due to noncardiac co-morbid conditions.

20. Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend), aortic arch atheroma (especially if thick [> 5 mm], protruding or ulcerated) or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta.

21. Native aortic annulus size < 19 mm or > 27 mm per the baseline diagnostic imaging.

22. Aortic root angulation > 70°.

23. Currently participating in an investigational drug or device study.

24. Active bacterial endocarditis within 6 months prior to the index procedure.

25. Bulky calcified aortic valve leaflets in close proximity to coronary ostia.

26. Non-calcified aortic annulus.

27. Iliofemoral vessel characteristics that would preclude safe insertion of the FlexNav™ delivery system with or without an arterial introducer sheath such as severe obstructive calcification, or severe tortuosity.

28. In the judgment of the investigator, a condition that could limit a patient's ability or willingness to participate in the study, comply with study required testing and/or follow- up visits or that could impact scientific integrity of the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rigshospitalet	Copenhagen		Denmark	2100
2	Policlinico San Donato	San Donato Milanese	Lombard	Italy	20097
3	Kantonsspital St. Gallen	St. Gallen		Switzerland	9007
4	Universitaets Spital Zuerich	Zürich		Switzerland	8091
5	Morriston Hospital - ABM University Health Board	Morriston	Swansea	United Kingdom	SA6 6NL
6	Royal Victoria Hospital	Belfast		United Kingdom	BT12 6BA

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Francesco Bedogni, MD, Policlinico San Donato

Study Documents (Full-Text)

• Study Protocol - Oct 23, 2018
• Statistical Analysis Plan - Nov 18, 2020

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT03724812
• Other Study ID Numbers: ABT-CIP-10260
• First Posted: Oct 30, 2018
• Last Update Posted: Nov 24, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Abbott Medical Devices: Aortic Stenosis; FlexNav™ Delivery System; Portico Delivery System; Transcatheter Aortic Valve Replacement; Heart Valve Disease; High surgical risk
• Additional relevant MeSH terms: Aortic Valve Stenosis; Constriction, Pathologic

Study Results

Participant Flow

Recruitment Details	Patients were enrolled between 26 February 2019 and 10 December 2019

Arm/Group Title	Portico Valve and FlexNav™ Delivery System
Arm/Group Description	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
Period Title: Overall Study
STARTED	46
Discharge	46
30 Day Follow-Up	45
6 Month Follow-Up	42
12-Month Follow-Up	42
COMPLETED	42
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Portico Valve and FlexNav™ Delivery System
Arm/Group Description	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 Participants	46
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	0 0%
>=65 years	46 100%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	85.4 (4.9)
Sex: Female, Male (Count of Participants)
Female	33 71.7%
Male	13 28.3%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Denmark	3 6.5%
Italy	17 37%
United Kingdom	22 47.8%
Switzerland	4 8.7%

Outcome Measures

1. Primary Outcome

Title	Major Vascular Complications
Description	Percentage of patients with a VARC-2 defined major vascular complication event
Time Frame	At 30 days post index procedure

Outcome Measure Data

Analysis Population Description

Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects)

Arm/Group Title	Portico Valve and FlexNav™ Delivery System
Arm/Group Description	Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
Measure Participants	46
Number (95% Confidence Interval) [percentage of participants]	4.3 9.3%

2. Other Pre-specified Outcome

Title	Non-hierarchical Composite Safety Endpoint
Description	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
Time Frame	30 days from the index procedure.

Outcome Measure Data

Analysis Population Description

Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects)

Arm/Group Title	Portico Valve and FlexNav™ Delivery System
Arm/Group Description	Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
Measure Participants	46
Number (95% Confidence Interval) [percentage of subjects]	6.5

3. Other Pre-specified Outcome

Title	All-Cause Mortality
Description	Percentage of patients with VARC 2 defined all-cause mortality
Time Frame	30 days from the index procedure

Outcome Measure Data

Analysis Population Description

Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects)

Arm/Group Title	Portico Valve and FlexNav™ Delivery System
Arm/Group Description	Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
Measure Participants	46
Number (95% Confidence Interval) [percentage of participants]	0 0%

4. Other Pre-specified Outcome

Title	Disabling Stroke
Description	Percentage of patients with a VARC-2 defined disabling stroke event
Time Frame	30 days from index procedure

Outcome Measure Data

Analysis Population Description

Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects)

Arm/Group Title	Portico Valve and FlexNav™ Delivery System
Arm/Group Description	Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
Measure Participants	46
Number (95% Confidence Interval) [percentage of participants]	0 0%

5. Other Pre-specified Outcome

Title	Life-threatening Bleeding Requiring Blood Transfusion
Description	Percentage of patients with a VARC-2 defined life-threatening bleeding event requiring blood transfusion
Time Frame	30 days from the index procedure

Outcome Measure Data

Analysis Population Description

Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects)

Arm/Group Title	Portico Valve and FlexNav™ Delivery System
Arm/Group Description	Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
Measure Participants	46
Number (95% Confidence Interval) [percentage of participants]	4.3 9.3%

6. Other Pre-specified Outcome

Title	Major Bleeding Event
Description	Percentage of patients with VARC 2 defined major bleeding event
Time Frame	30 days from index procedure

Outcome Measure Data

Analysis Population Description

Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects)

Arm/Group Title	Portico Valve and FlexNav™ Delivery System
Arm/Group Description	Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
Measure Participants	46
Number (95% Confidence Interval) [percentage of participants]	4.3 9.3%

7. Other Pre-specified Outcome

Title	Acute Kidney Injury
Description	Percentage of patients with a VARC 2 defined acute kidney injury event
Time Frame	30 days from index procedure

Outcome Measure Data

Analysis Population Description

Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects)

Arm/Group Title	Portico Valve and FlexNav™ Delivery System
Arm/Group Description	Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
Measure Participants	46
Number (95% Confidence Interval) [percentage of participants]	0 0%

8. Other Pre-specified Outcome

Title	Minor Vascular Complication
Description	Percentage of patients with a VARC-2 defined minor vascular complication
Time Frame	30 days from index procedure

Outcome Measure Data

Analysis Population Description

Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects)

Arm/Group Title	Portico Valve and FlexNav™ Delivery System
Arm/Group Description	Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
Measure Participants	46
Number (95% Confidence Interval) [percentage of participants]	15.2 33%

9. Other Pre-specified Outcome

Title	New Permanent Pacemaker Implant
Description	Percentage of patients requiring a new permanent pacemaker. Excludes patients with a pre-existing permanent pacemaker at baseline
Time Frame	30 days from index procedure

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Portico Valve and FlexNav™ Delivery System
Arm/Group Description	Subjects without a permanent pacemaker at baseline that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
Measure Participants	42
Number (95% Confidence Interval) [percentage of participants]	14.3 31.1%

10. Other Pre-specified Outcome

Title	Severity of Paravalvular Leak
Description	Echocardiographic core-laboratory derived severity of paravalvular leak
Time Frame	30 days from index procedure

Outcome Measure Data

Analysis Population Description

Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects) with an analyzable echocardiogram at 30 days

Arm/Group Title	Portico Valve and FlexNav™ Delivery System
Arm/Group Description	Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
Measure Participants	43
None/Trace/Trivial PVL	53.5
Mild PVL	46.5
Moderate PVL	0
Severe PVL	0

11. Other Pre-specified Outcome

Title	NYHA Functional Classification
Description	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)
Time Frame	30 days from index procedure

Outcome Measure Data

Analysis Population Description

Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects). Information was not available for one subject.

Arm/Group Title	Portico Valve and FlexNav™ Delivery System
Arm/Group Description	Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
Measure Participants	45
NYHA I	48.9 106.3%
NYHA II	48.9 106.3%
NYHA III	2.2 4.8%
NYHA IV	0 0%

12. Other Pre-specified Outcome

Title	Kansas City Cardiomyopathy Questionnaire Quality of Life (QOL) Score
Description	KCCQ Overall summary score (range 0-100 where a higher score indicates a better quality of life and physical function)
Time Frame	30 days from index procedure

Outcome Measure Data

Analysis Population Description

Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects). Information was not available for 2 subjects.

Arm/Group Title	Portico Valve and FlexNav™ Delivery System
Arm/Group Description	Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
Measure Participants	44
Mean (Standard Deviation) [score on a scale]	66.46 (20.86)

13. Other Pre-specified Outcome

Title	Technical Device Success
Description	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.
Time Frame	Over the duration of index procedure, an average of 60.6 minutes

Outcome Measure Data

Analysis Population Description

Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects)

Arm/Group Title	Portico Valve and FlexNav™ Delivery System
Arm/Group Description	Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
Measure Participants	46
Number [percentage of participants]	100 217.4%

14. Other Pre-specified Outcome

Title	All-Cause Mortality or Disabling Stroke
Description	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
Time Frame	One year (365 days) from index procedure

Outcome Measure Data

Analysis Population Description

sensitivity analyses censoring subject's first COVID-19 related endpoint event

Arm/Group Title	Portico Valve and FlexNav™ Delivery System
Arm/Group Description	Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
Measure Participants	46
Mean (95% Confidence Interval) [percentage of participants]	2.2 4.8%

15. Other Pre-specified Outcome

Title	All-Cause Mortality
Description	Percentage of patients that died at one year from the index procedure censored for COVID-19 related endpoint events
Time Frame	One year (365 days) from index procedure

Outcome Measure Data

Analysis Population Description

sensitivity analyses censoring subject's first COVID-19 related endpoint event

Arm/Group Title	Portico Valve and FlexNav™ Delivery System
Arm/Group Description	Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
Measure Participants	46
Mean (95% Confidence Interval) [percentage of participants]	2.2 4.8%

16. Other Pre-specified Outcome

Title	Disabling Stroke
Description	Percentage of patients with a disabling stroke at one year from index procedure censored for COVID-19 related endpoint events
Time Frame	One Year (365 days) from index procedure

Outcome Measure Data

Analysis Population Description

sensitivity analyses censoring subject's first COVID-19 related endpoint event

Arm/Group Title	Portico Valve and FlexNav™ Delivery System
Arm/Group Description	Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
Measure Participants	46
Mean (95% Confidence Interval) [percentage of participants]	0 0%

17. Other Pre-specified Outcome

Title	Severity of Paravalvular Leak
Description	Echocardiographic core-laboratory derived severity of paravalvular leak
Time Frame	One year from index procedure

Outcome Measure Data

Analysis Population Description

Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects) with an analyzable echocardiogram at 30 days

Arm/Group Title	Portico Valve and FlexNav™ Delivery System
Arm/Group Description	Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
Measure Participants	36
None/Trace/Trivial PVL	72.2
Mild PVL	27.8
Moderate PVL	0.0
Severe PVL	0.0

18. Other Pre-specified Outcome

Title	NYHA Functional Classification
Description	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)
Time Frame	One year from index procedure

Outcome Measure Data

Analysis Population Description

Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects). Information was not available for one subject.

Arm/Group Title	Portico Valve and FlexNav™ Delivery System
Arm/Group Description	Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
Measure Participants	40
NYHA I	57.5 125%
NYHA II	40.0 87%
NYHA III	2.5 5.4%
NYHA IV	0.0 0%

19. Other Pre-specified Outcome

Title	Kansas City Cardiomyopathy Questionnaire Quality of Life (QOL) Score
Description	KCCQ Overall summary score (range 0-100 where a higher score indicates a better quality of life and physical function)
Time Frame	One year from index procedure

Outcome Measure Data

Analysis Population Description

Analysis population included all subjects in whom a Portico valve implant was attempted (enrolled subjects). Information was not available for 2 subjects.

Arm/Group Title	Portico Valve and FlexNav™ Delivery System
Arm/Group Description	Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
Measure Participants	40
Mean (Standard Deviation) [score on a scale]	71.11 (16.71)

Adverse Events

Time Frame	Site-reported adverse events related to the investigational study device within 1 year follow-up
Arm/Group Title	Portico Valve and FlexNav™ Delivery System
Arm/Group Description	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
	Portico Valve and FlexNav™ Delivery System
	Affected / at Risk (%)	# Events
Total	2/46 (4.3%)
Serious Adverse Events
	Portico Valve and FlexNav™ Delivery System
	Affected / at Risk (%)	# Events
Total	21/46 (45.7%)
Blood and lymphatic system disorders
Anemia	2/46 (4.3%)	2
Cardiac disorders
Arrhythmias	3/46 (6.5%)	4
Endocarditis	1/46 (2.2%)	2
Cardiac Arrest	1/46 (2.2%)	1
Pericardial Effusion	1/46 (2.2%)	1
Pericardial Tamponade	1/46 (2.2%)	1
Heart Block	5/46 (10.9%)	5
Heart Failure	5/46 (10.9%)	6
Coronary Artery Disease	1/46 (2.2%)	1
Gastrointestinal disorders
Pancreatitis	1/46 (2.2%)	1
General disorders
General	10/46 (21.7%)	12
Bleeding	1/46 (2.2%)	1
Infections and infestations
Bacterial Infection	2/46 (4.3%)	3
Injury, poisoning and procedural complications
Vascular Access Site Complications	2/46 (4.3%)	2
Musculoskeletal and connective tissue disorders
Fracture	2/46 (4.3%)	2
General-Musculoskeletal Symptoms	1/46 (2.2%)	1
Nervous system disorders
Stroke	2/46 (4.3%)	2
Syncope	1/46 (2.2%)	3
Seizure/Convulsions/Epilepsy	1/46 (2.2%)	1
Renal and urinary disorders
Urinary Tract Infection	1/46 (2.2%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnea	2/46 (4.3%)	2
Pneumonia	2/46 (4.3%)	2
Other (Not Including Serious) Adverse Events
	Portico Valve and FlexNav™ Delivery System
	Affected / at Risk (%)	# Events
Total	19/46 (41.3%)
Blood and lymphatic system disorders
Anemias	5/46 (10.9%)	5
Bleeding	1/46 (2.2%)	1
Hematoma	2/46 (4.3%)	2
Thrombocytopenia	1/46 (2.2%)	1
Cardiac disorders
Arrhythmias	4/46 (8.7%)	4
Arterial Hypertension	1/46 (2.2%)	1
Heart Block	10/46 (21.7%)	10
Endocrine disorders
Thyroid Disorders	1/46 (2.2%)	1
General disorders
Allergy	1/46 (2.2%)	1
Other	7/46 (15.2%)	10
Dental Disorders	1/46 (2.2%)	1
Product Issues
Aortic Valve Regurgitation/Aortic Valve Insufficiency/Valvular Regurgitation Aortic Valve	1/46 (2.2%)	1
Renal and urinary disorders
Edema	1/46 (2.2%)	1
Urinary Tract Infection	1/46 (2.2%)	1
Skin and subcutaneous tissue disorders
Rash	1/46 (2.2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.