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PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR

RECRUITING

This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

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Study details:

This is a prospective, randomized, controlled, multicenter study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 / SAPIEN 3 Ultra /SAPIEN 3 Ultra RESILIA THV or Clinical Surveillance.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

65 years of age or older at time of randomization

Moderate aortic stenosis

Subject has symptoms or evidence of cardiac damage/dysfunction

The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.

Exclusion criteria

Native aortic annulus size unsuitable for the THV

Anatomical characteristics that would preclude safe transfemoral placement of the introducer sheath or safe passage of the delivery system

Aortic valve is unicuspid or non-calcified

Bicuspid aortic valve with an aneurysmal ascending aorta > 4.5 cm or severe raphe/leaflet calcification

Pre-existing mechanical or bioprosthetic aortic valve

Severe aortic regurgitation

Prior balloon aortic valvuloplasty to treat severe AS

LVEF < 20%

Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVR

Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation

Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR

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Eligibility

Age eligible for study : 65 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2021-10-12

Primary completion: 2029-06-01

Study completion finish: 2037-06-01

Study type

TREATMENT

Phase

Trial ID

NCT04889872

Intervention or treatment

DEVICE: SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA

Conditions

• Aortic Stenosis, Calcific
• Aortic Valve Stenosis

Image related to Aortic Stenosis, Calcific

Condition: Aortic Stenosis, Calcific, Aortic Valve Stenosis
DEVICE: SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA
Adelaide, South Australia, Australia and more
Sponsor: Edwards Lifesciences

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Find a site

Closest Location:

Royal Adelaide Hospital

Research sites nearby

Select from list below to view details:

Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Monash Health
Clayton, Victoria, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: TAVR Transcatheter Aortic Valve Replacement (TAVR)	DEVICE: SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Patients will be implanted with a SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA heart valve
NO_INTERVENTION: CS Clinical Surveillance (CS)	Not specified

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Primary Effectiveness Endpoint	Non-hierarchical composite of death, and heart failure hospitalization or event	2 years
Primary Safety Endpoint	Non-hierarchical composite of death, stroke, life threatening or fatal bleeding, acute kidney injury stage 4, hospitalization due to device- or procedure-related complication, and valve dysfunction requiring reintervention	30 days

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Death, stroke, or unplanned cardiovascular hospitalization	The number of patients that had this event	2 years
Death, unplanned cardiovascular hospitalization, or decrease of > 10 points in Kansas City Cardiomyopathy Questionnaire (KCCQ)	The number of patients that met all these criteria	2 years
Unplanned cardiovascular hospitalization	The number of patients that had this event	2 years
Left ventricle (LV) mass index	Echocardiographic measurement of the size of the left ventricle	2 years
Stroke volume index	Echocardiographic measurement of the volume of blood pumped out of the left ventricle during contraction.	2 years
Diastolic dysfunction ≥ Grade 2	Echocardiographic measurement of the stiffness of the left ventricle.	2 years
N-Terminal Pro B-type Natriuretic Peptide (NT-ProBNP)	NT-ProBNP is a hormone that measures heart failure. Levels goes up when heart failure develops or gets worse, and levels goes down when heart failure is stable.	2 years
KCCQ overall score	Change from baseline in KCCQ. The KCCQ is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.	2 years
Reduction in LVEF ≥ 5% from baseline AND LVEF < 60%	The number of patients that meet these criteria	2 years
New onset atrial fibrillation	The number of patients that develop this condition	2 years

Frequently Asked Questions

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References

Clinical Trials Gov: PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR