Trial Outcomes & Findings for Portico TAVI Implant With Transfemoral Delivery System (NCT NCT01493284)

NCT ID: NCT01493284

Last Updated: 2019-02-04

Results Overview

Number of participants that reported all cause mortality

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 222 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2019-02-04

Participant Flow

Participant milestones

Measure	Transfemoral Transfemoral access
Overall Study STARTED	222
Overall Study COMPLETED	161
Overall Study NOT COMPLETED	61

Reasons for withdrawal

Measure	Transfemoral Transfemoral access
Overall Study Death	29
Overall Study Withdrawal by Subject	32

Baseline Characteristics

Portico TAVI Implant With Transfemoral Delivery System

Baseline characteristics by cohort

Measure	Transfemoral n=222 Participants Transfemoral access
Age, Continuous	83.0 years STANDARD_DEVIATION 4.6 • n=5 Participants
Sex: Female, Male Female	165 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants
Region of Enrollment Netherlands	15 Participants n=5 Participants
Region of Enrollment Denmark	3 Participants n=5 Participants
Region of Enrollment United Kingdom	48 Participants n=5 Participants
Region of Enrollment Australia	15 Participants n=5 Participants
Region of Enrollment Germany	141 Participants n=5 Participants
STS risk score of mortality	5.8 Percentage STANDARD_DEVIATION 3.3 • n=5 Participants
NYHA class III/IV	175 Participants n=5 Participants
History of pulmonary hypertension	68 Participants n=5 Participants
Porcelain aorta	8 Participants n=5 Participants
History of atrial fibrillation	85 Participants n=5 Participants
Renal failure/insufficiency	73 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Number of participants that reported all cause mortality

Outcome measures

Measure	Transfemoral n=222 Participants Transfemoral access
All Cause Mortality	8 Participants

SECONDARY outcome

Timeframe: 30 days

Number of participants with select cardiovascular adverse events

Outcome measures

Measure	Transfemoral n=222 Participants Transfemoral access
Number of Select Cardiovascular Adverse Events Cardiovascular death	8 participants
Number of Select Cardiovascular Adverse Events Myocardial Infarction	7 participants
Number of Select Cardiovascular Adverse Events Stage 3 Acute kidney injury	3 participants
Number of Select Cardiovascular Adverse Events Disabling (major) stroke	7 participants
Number of Select Cardiovascular Adverse Events Non-disabling (minor) stroke	5 participants
Number of Select Cardiovascular Adverse Events Life threatening or disabling bleeding	8 participants

SECONDARY outcome

Timeframe: day 30

Population: Analysis for participants that completed visit and assessment

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.

Outcome measures

Measure	Transfemoral n=181 Participants Transfemoral access
Participant NYHA Classification at Day 30 NYHA 1	52 Participants
Participant NYHA Classification at Day 30 NYHA II	105 Participants
Participant NYHA Classification at Day 30 NYHA III	22 Participants
Participant NYHA Classification at Day 30 NYHA IV	2 Participants

SECONDARY outcome

Timeframe: 7 days

Population: Successful vascular access, delivery and deployment of the device

1. Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system

2. Correct position of the device in the proper anatomical location

3. 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)

4. Only one valve implanted in the proper anatomical location

Outcome measures

Measure	Transfemoral n=222 Participants Transfemoral access
Number of Participants With Acute Device Success	216 Participants

Adverse Events

Transfemoral

Serious events: 102 serious events

Other events: 18 other events

Deaths: 29 deaths

Serious adverse events

Measure	Transfemoral n=222 participants at risk Transfemoral access
General disorders All-cause death	13.1% 29/222 • Number of events 29 • 1-year
Cardiac disorders Cardiovascular Death	9.0% 20/222 • Number of events 20 • 1-year
Cardiac disorders Myocardial infarction	3.2% 7/222 • Number of events 7 • 1-year
Renal and urinary disorders Stage 3 acute kidney injury	2.7% 6/222 • Number of events 6 • 1-year
Vascular disorders Life-threatening or disabling bleeding	5.0% 11/222 • Number of events 11 • 1-year
Renal and urinary disorders Disabling stroke	5.4% 12/222 • Number of events 12 • 1-year
Vascular disorders Major vascular complications	8.6% 19/222 • Number of events 23 • 1-year
Renal and urinary disorders Stage 1 acute kidney injury	2.3% 5/222 • Number of events 5 • 1-year
Renal and urinary disorders Stage 2 acute kidney injury	0.90% 2/222 • Number of events 2 • 1-year
Renal and urinary disorders Non-disabling stroke	2.7% 6/222 • Number of events 6 • 1-year
Cardiac disorders Pacemaker implantation	14.9% 33/222 • Number of events 33 • 1-year
Cardiac disorders Heart failure	16.7% 37/222 • Number of events 47 • 1-year
Cardiac disorders Coronary obstruction	0.45% 1/222 • Number of events 1 • 1-year

Other adverse events

Measure	Transfemoral n=222 participants at risk Transfemoral access
Cardiac disorders Hypertension	3.2% 7/222 • Number of events 7 • 1-year
Investigations Hyponatremia	2.7% 6/222 • Number of events 6 • 1-year
Infections and infestations Urinary tract infection	2.7% 6/222 • Number of events 6 • 1-year

Additional Information

Sr Clinical Scientist

St Jude Medical

Phone: 4159179696

Email: alicia.kimber@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place