Health TrialsbyHealthPanel

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

ConditionAortic Stenosis, Severe
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorEdwards Lifesciences

About this trial

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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+)

Trial design

Design model

Single group

Treatments tested in this trial

  • SAPIEN X4 THV

    Device

    Implantation of the SAPIEN X4 valve

  • SAPIEN X4S

    Device

    Implantation of the SAPIEN X4S valve

Treatment groups

1,234 Participants
are divided into 3 treatment groups
Group A: TAVR - Main CohortExperimental treatment 1 intervention
Group B: TAVR - Bicuspid RegistryExperimental treatment 1 intervention
Group C: TAVR - X4S RegistryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Non-hierarchical composite of death and stroke

The number of patients that died or had a stroke

Time frame
1 year

Secondary outcomes

1

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.

Time frame
1 year
2

Paravalvular leak

Paravalvular leak will be categorized as None, Trace, Mild, Mild-Moderate, Moderate, Moderate-Severe, or Severe

Time frame
30 days
3

New permanent pacemaker implantation

The number of patients with this event

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Edwards Lifesciences

Lead sponsor

Source ClinicalTrials.gov
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