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ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve

RECRUITING

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).

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Study details:

This is a prospective, single arm, multicenter study. Subjects with bicuspid aortic valve morphology will be enrolled in a separate registry.

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Eligibility criteria

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

Inclusion criteria

Severe, calcific AS

Native aortic annulus size suitable for SAPIEN X4 THV

NYHA functional class ≥ II

The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion criteria

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

Aortic valve is unicuspid, bicuspid or non-calcified

Pre-existing mechanical or bioprosthetic valve in any position

Severe aortic regurgitation (> 3+)

Severe mitral regurgitation (> 3+) or ≥ moderate mitral stenosis

Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months

Left ventricular ejection fraction < 20%

Cardiac imaging evidence of intracardiac mass, thrombus or vegetation

Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant PVL after THV implantation

Increased risk of coronary artery obstruction after THV implantation

Myocardial infarction within 30 days prior to the study procedure

Hypertrophic cardiomyopathy with subvalvular obstruction

Subjects with planned concomitant ablation for atrial fibrillation

Complex coronary artery disease (CAD) that cannot be optimally treated by percutaneous coronary intervention (PCI)

Any surgical or transcatheter procedure within 30 days prior to the study procedure (unless part of planned strategy for treatment of CAD). Implantation of a permanent pacemaker or implantable cardioverter defibrillator (ICD) is not considered an exclusion.

Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure (unless part of planned strategy for treatment of CAD)

Endocarditis within 180 days prior to the study procedure

Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure

Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure

Renal insufficiency and/or renal replacement therapy

Leukopenia, anemia, thrombocytopenia

Inability to tolerate or condition precluding treatment with antithrombotic therapy

Hypercoagulable state or other condition that increases risk of thrombosis

Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication

Subject refuses blood products

BMI > 50 kg/m2

Estimated life expectancy < 24 months

Female who is pregnant or lactating

Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments

Participating in another investigational drug or device study that has not reached its primary endpoint

Subject considered to be part of a vulnerable population

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Eligibility

Age eligible for study : 0 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-06-20

Primary completion: 2025-06-01

Study completion finish: 2034-12-01

Study type

TREATMENT

Phase

Trial ID

NCT05172960

Intervention or treatment

DEVICE: SAPIEN X4 THV

Conditions

• Aortic Stenosis, Severe

Image related to Aortic Stenosis, Severe

Condition: Aortic Stenosis, Severe
DEVICE: SAPIEN X4 THV
Adelaide, South Australia, Australia and more
Sponsor: Edwards Lifesciences

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

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
St. Andrews War Memorial Hospital
Spring Hill, Queensland, Australia
The Royal Melbourne Hospital
Parkville, Not Specified, 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 - Main Cohort Subjects will undergo transcatheter aortic valve replacement (TAVR)	DEVICE: SAPIEN X4 THV Implantation of the SAPIEN X4 valve
EXPERIMENTAL: TAVR - Bicuspid Registry Subjects with bicuspid aortic valve morphology will undergo TAVR	DEVICE: SAPIEN X4 THV Implantation of the SAPIEN X4 valve

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Non-hierarchical composite of death and stroke	The number of patients that died or had a stroke	1 year

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Favorable outcome per VARC-3: Composite of 1) alive, 2) Kansas City Cardiomyopathy Questionnaire (KCCQ) score ≥ 60, and 3) KCCQ score decrease ≤10 points from baseline	The number of patients that met all of these criteria. The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.	1 year
Paravalvular leak	Paravalvular leak will be categorized as None, Trace, Mild, Mild-Moderate, Moderate, Moderate-Severe, or Severe	30 days
New permanent pacemaker implantation	The number of patients with this event	30 days

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve