The SOLACE-AU Clinical Trial

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2018-08-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of the study is to observe the safety, efficacy and cost effectiveness of the Edwards SAPIEN XT valve for the treatment of severe calcific degenerative aortic stenosis.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05172960

Aortic Stenosis, Severe

ACTIVE_NOT_RECRUITING NA

SOURCE XT REGISTRY

NCT01238497

Severe Aortic Stenosis

COMPLETED

ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

NCT05172973

Aortic Valve Insufficiency Aortic Valve Stenosis

RECRUITING NA

ACURATE Prime XL Human Feasibility Study

NCT05224245

Aortic Stenosis

COMPLETED NA

PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve

NCT03225001

Aortic Stenosis Cardiomyopathy, Hypertrophic

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a multi-centre, prospective, consecutively enrolled, non-randomized clinical trial. The comparatator group will consist of subjects undergoing surgical aortic valve replacement in Cohort A of the PARTNER II Trial \[NCT01314313\].

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Severe, Symptomatic Aortic Stenosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Test

SAPIEN XT™ valve with the NovaFlex and NovaFlex+ delivery systems.

Group Type EXPERIMENTAL

TAVR Implantation of the Transcatheter Aortic Valve Prosthesis

Intervention Type DEVICE

Operable subjects

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TAVR Implantation of the Transcatheter Aortic Valve Prosthesis

Operable subjects

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Implantation of the Transcatheter Aortic Valve Prosthesis

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age \> 70 years
* STS Score \> 4
* Heart team agrees on eligibility including assessment that TAVR or AVR is appropriate

Exclusion Criteria

* Age \<70 years
* Evidence of an acute myocardial infarction ≤ 30 days
* Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified
* Stroke or transient ischemic attack (TIA) within 6 months of the procedure

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No