Portico TAVI Implant With Transfemoral Delivery System

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01493284
• Collaborator: (none)
• Enrollment: 222
• Locations: 14
• Arm: 1
• Duration (Months): 57
• Patients Per Site: 15.9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and the SJM TAVI Transfemoral Transcatheter delivery system in subjects with severe symptomatic aortic stenosis (AS).

Condition or Disease	Intervention/Treatment	Phase
Symptomatic Aortic Stenosis	Device: Transcatheter Aortic Valve Implantation	N/A

Detailed Description

Data will be collected at baseline, procedure, discharge, 30 days post implant, 3 months post implant, 6 months post implant, and 12 months post implant.

Study Design

• Study Type: Interventional
• Actual Enrollment: 222 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Assessment Of The St. Jude Medical Portico™ Transcatheter Aortic Valve Implant (TAVI) And The SJM TAVI Transfemoral Delivery System (Portico TF EU)
• Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Transfemoral Access Transfemoral Access for transcatheter aortic valve implant	Device: Transcatheter Aortic Valve Implantation; Placement of the SJM Portico aortic valve with a transfemoral delivery system

Outcome Measures

Primary Outcome Measures

1. All Cause Mortality [30 days]

   Number of participants that reported all cause mortality

Secondary Outcome Measures

1. Number of Select Cardiovascular Adverse Events [30 days]

   Number of participants with select cardiovascular adverse events

2. Participant NYHA Classification at Day 30 [day 30]

   The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256.

3. Number of Participants With Acute Device Success [7 days]

   Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system Correct position of the device in the proper anatomical location Intended performance of the prosthetic heart valve (Aortic Valve Area >1.2 cm2 and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, without moderate or severe prosthetic valve AR) Only one valve implanted in the proper anatomical location

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject has given written study Informed Consent for participation prior to procedure.

2. Subject is ≥ 18 years of age or legal age in host country.

3. Subject's aortic annulus diameter meets the range indicated in the Instructions for use as measured by echocardiogram (echo) or CT conducted within the past 90 days.

4. Subject has senile degenerative aortic stenosis with echocardiography (echo) derived mean gradient >40mmHg or jet velocity greater than 4.0 m/s or an initial valve area of <1.0 cm2 (or aortic valve area index ≤ 0.6 cm2/m2). (Baseline measurement taken by echo within 30 days of procedure).

5. Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II or greater.

6. Subject is deemed high operable risk and suitable for TAVI per the medical opinion of the Subject Selection Committee (See Section 3.1 for the definition of the Subject Selection Committee)

7. Subject's predicted operative mortality or serious, irreversible morbidity risk is <50% at 30 days.

8. In the opinion of the Subject Selection Committee and based upon angiographic measurements, the subject has suitable peripheral vessels and aorta to allow for access of the 18 French delivery system.

9. Subject has structurally normal cardiac anatomy.

10. Subject is willing and able to comply with all required follow-up evaluations.

Exclusion Criteria:

1. Subject has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months (≤180 days) of the index procedure.

2. Subject has carotid artery disease requiring intervention.

3. Subject has evidence of a myocardial infarction (MI) within the past 6 months (≤180 days) of the index procedure.

4. Subject has hypertrophic cardiomyopathy.

5. Subject has a native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.

6. Subject has mitral or tricuspid valvular regurgitation (>grade III) or moderate to severe mitral stenosis.

7. Subject has aortic root angulation >70 degrees (horizontal aorta).

8. Subject has a pre-existing prosthetic valve or prosthetic ring in any position.

9. Subject refuses blood transfusion or surgical valve replacement.

10. Subject has left ventricular ejection fraction (LVEF) < 20%.

11. The subject has documented, untreated coronary artery disease (CAD) requiring revascularization.

12. Subject has severe basal septal hypertrophy.

13. Subject has had a percutaneous interventional or other invasive cardiac or peripheral procedure ≤ 14 days of the index procedure.

14. Subject has a history of or has active endocarditis.

15. Subject has echocardiographic evidence of intracardiac mass, thrombus, or vegetation.

16. Subject has hemodynamic instability (requiring inotropic support or mechanical heart assistance).

17. Subject is in acute pulmonary edema or requiring intravenous diuretic therapy to stabilize heart failure.

18. Subject with significant pulmonary disease.

19. Subject has significant chronic steroid use.

20. Subject has a known hypersensitivity or contraindication to anticoagulant or antiplatelet medication.

21. Subject has renal insufficiency as evidenced by a serum creatinine > 3.0 mg/dL (265µmol/L) or end-stage renal disease requiring chronic dialysis.

22. Subject has morbid obesity defined as BMI ≥ 40.

23. Subject's iliac arteries have severe calcification, tortuosity (>two 90 degree bends), diameter <6mm, or subject has had an aorto-femoral bypass.

24. Subject has ongoing infection or sepsis.

25. Subject has blood dyscrasias (leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy).

26. Subject has a current autoimmune disease that, in the opinion of the Principal Investigator precludes the subject from study participation.

27. Subject has significant aortic disease, including:

• aortic abdominal aneurysm (AAA) ≥ 4cm

• thoracic aneurysm (defined as a maximal luminal diameter of 5 cm or greater)

• marked tortuosity

• significant aortic arch atheroma or narrowing of the abdominal or thoracic aorta

• severe tortuosity of the thoracic aorta.

1. Subject has a pre-existing endovascular stent graft in the supra- or infrarenal aorta or pre-existing stent grafts in the ileo-femoral arteries.

2. Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within the past 90 days prior to the index procedure.

3. Subject is currently participating in another investigational drug or device study.

4. Subject requires emergency surgery for any reason.

5. Subject has a life expectancy < 12 months.

6. Subject has other medical, social or psychological conditions that, in the opinion of the Subject Selection Committee, preclude the subject from study participation.

7. Subject is suffering from dementia or admitted to a chronic care facility which would fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits.

8. Subject has a known allergy to contrast media, nitinol alloys, porcine tissue, or bovine tissue.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Adelaide Royal Hospital	Adelaide		Australia
2	Rigshospitalet Copenhagen	Copenhagen		Denmark
3	Kerckhoff Klinik	Bad Nauheim		Germany
4	Heart Center Bernau	Bernau		Germany
5	Asklepios Klinik-St. Georg	Hamburg		Germany
6	Klinikum der Universität Jena	Jena		Germany
7	Klinik fur Herzhirurgie Karlruhe GmbH	Karlsruhe		Germany
8	Herzzentrum Leipzig	Leipzig		Germany
9	Medical Center Leeuwarden	Leeuwarden		Netherlands
10	Royal Victoria Hospital	Belfast	Northern Ireland	United Kingdom	BT12 6BA
11	Glenfield Hospital	Leicester		United Kingdom
12	Kings College	London		United Kingdom
13	St. Thomas' Hospital	London		United Kingdom
14	Derriford Hospital, Plymouth	Plymouth		United Kingdom

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Ganesh Manoharan, MD, Royal Victoria Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT01493284
• Other Study ID Numbers: 1105
• First Posted: Dec 15, 2011
• Last Update Posted: Feb 4, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Abbott Medical Devices: aortic stenosis; aortic valve stenosis; valvular heart disease; aortic valve replacement; transcatheter aortic valve implantation; TAVI
• Additional relevant MeSH terms: Aortic Valve Stenosis; Constriction, Pathologic

Study Results

Participant Flow

Arm/Group Title	Transfemoral
Arm/Group Description	Transfemoral access
Period Title: Overall Study
STARTED	222
COMPLETED	161
NOT COMPLETED	61

Baseline Characteristics

Arm/Group Title	Transfemoral
Arm/Group Description	Transfemoral access
Overall Participants	222
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	83.0 (4.6)
Sex: Female, Male (Count of Participants)
Female	165 74.3%
Male	57 25.7%
Region of Enrollment (Count of Participants)
Netherlands	15 6.8%
Denmark	3 1.4%
United Kingdom	48 21.6%
Australia	15 6.8%
Germany	141 63.5%
STS risk score of mortality (Percentage) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percentage]	5.8 (3.3)
NYHA class III/IV (Count of Participants)
Count of Participants [Participants]	175 78.8%
History of pulmonary hypertension (Count of Participants)
Count of Participants [Participants]	68 30.6%
Porcelain aorta (Count of Participants)
Count of Participants [Participants]	8 3.6%
History of atrial fibrillation (Count of Participants)
Count of Participants [Participants]	85 38.3%
Renal failure/insufficiency (Count of Participants)
Count of Participants [Participants]	73 32.9%

Outcome Measures

1. Primary Outcome

Title	All Cause Mortality
Description	Number of participants that reported all cause mortality
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Transfemoral
Arm/Group Description	Transfemoral access
Measure Participants	222
Count of Participants [Participants]	8 3.6%

2. Secondary Outcome

Title	Number of Select Cardiovascular Adverse Events
Description	Number of participants with select cardiovascular adverse events
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Transfemoral
Arm/Group Description	Transfemoral access
Measure Participants	222
Cardiovascular death	8 3.6%
Myocardial Infarction	7 3.2%
Stage 3 Acute kidney injury	3 1.4%
Disabling (major) stroke	7 3.2%
Non-disabling (minor) stroke	5 2.3%
Life threatening or disabling bleeding	8 3.6%

3. Secondary Outcome

Title	Participant NYHA Classification at Day 30
Description	The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256.
Time Frame	day 30

Outcome Measure Data

Analysis Population Description

Analysis for participants that completed visit and assessment

Arm/Group Title	Transfemoral
Arm/Group Description	Transfemoral access
Measure Participants	181
NYHA 1	52 23.4%
NYHA II	105 47.3%
NYHA III	22 9.9%
NYHA IV	2 0.9%

4. Secondary Outcome

Title	Number of Participants With Acute Device Success
Description	Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system Correct position of the device in the proper anatomical location Intended performance of the prosthetic heart valve (Aortic Valve Area >1.2 cm2 and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, without moderate or severe prosthetic valve AR) Only one valve implanted in the proper anatomical location
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

Successful vascular access, delivery and deployment of the device

Arm/Group Title	Transfemoral
Arm/Group Description	Transfemoral access
Measure Participants	222
Count of Participants [Participants]	216 97.3%

Adverse Events

Time Frame	1-year
Arm/Group Title	Transfemoral
Arm/Group Description	Transfemoral access
All Cause Mortality
	Transfemoral
	Affected / at Risk (%)	# Events
Total	29/222 (13.1%)
Serious Adverse Events
	Transfemoral
	Affected / at Risk (%)	# Events
Total	102/222 (45.9%)
Cardiac disorders
Cardiovascular Death	20/222 (9%)	20
Myocardial infarction	7/222 (3.2%)	7
Pacemaker implantation	33/222 (14.9%)	33
Heart failure	37/222 (16.7%)	47
Coronary obstruction	1/222 (0.5%)	1
General disorders
All-cause death	29/222 (13.1%)	29
Renal and urinary disorders
Stage 3 acute kidney injury	6/222 (2.7%)	6
Disabling stroke	12/222 (5.4%)	12
Stage 1 acute kidney injury	5/222 (2.3%)	5
Stage 2 acute kidney injury	2/222 (0.9%)	2
Non-disabling stroke	6/222 (2.7%)	6
Vascular disorders
Life-threatening or disabling bleeding	11/222 (5%)	11
Major vascular complications	19/222 (8.6%)	23
Other (Not Including Serious) Adverse Events
	Transfemoral
	Affected / at Risk (%)	# Events
Total	18/222 (8.1%)
Cardiac disorders
Hypertension	7/222 (3.2%)	7
Infections and infestations
Urinary tract infection	6/222 (2.7%)	6
Investigations
Hyponatremia	6/222 (2.7%)	6

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS 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.