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Transcatheter Heart Valve

TAVR for Aortic Stenosis (PROGRESS Trial)

N/A

Waitlist Available

Led By Raj Makkar, MD

Research Sponsored by Edwards Lifesciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderate aortic stenosis

65 years of age or older at time of randomization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

PROGRESS Trial Summary

This trial is testing a new heart valve to see if it is safe and effective for people with aortic stenosis.

Who is the study for?

This trial is for people aged 65 or older with moderate, calcific aortic stenosis who may have symptoms or signs of heart damage. They must understand the study and agree to participate. It's not for those with mechanical heart valves, severe valve leakage, very weak hearts (LVEF < 20%), certain types of aortic valves, high risk of artery blockage after TAVR, previous treatments for severe AS, unsuitable heart anatomy for the procedure, or evidence of intracardiac mass.Check my eligibility

What is being tested?

The PROGRESS trial tests the safety and effectiveness of Edwards SAPIEN Transcatheter Heart Valve systems in treating moderate aortic stenosis. Participants will receive one of these valve systems through a less invasive method compared to traditional surgery.See study design

What are the potential side effects?

Possible side effects include risks associated with heart valve replacement such as bleeding complications, blood vessel complications at the site where devices are inserted (groin), irregular heartbeat rhythms that might require a permanent pacemaker implantation, stroke risk during and after the procedure.

PROGRESS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with moderate aortic stenosis.

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I am 65 years old or older.

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I have heart problems or damage.

PROGRESS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Effectiveness Endpoint

Primary Safety Endpoint

Secondary outcome measures

Death, stroke, or unplanned cardiovascular hospitalization

Death, unplanned cardiovascular hospitalization, or decrease of > 10 points in Kansas City Cardiomyopathy Questionnaire (KCCQ)

Diastolic dysfunction ≥ Grade 2

+7 more

PROGRESS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TAVRExperimental Treatment1 Intervention

Transcatheter Aortic Valve Replacement (TAVR)

Group II: CSActive Control1 Intervention

Clinical Surveillance (CS)

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor

180 Previous Clinical Trials

60,280 Total Patients Enrolled

61 Trials studying Aortic Valve Stenosis

30,491 Patients Enrolled for Aortic Valve Stenosis

Raj Makkar, MDPrincipal InvestigatorCedars-Sinai Medical Center, Los Angeles, CA, USA

3 Previous Clinical Trials

3,027 Total Patients Enrolled

Jeroen J Bax, MD, PhDPrincipal InvestigatorLeiden University Medical Center, Leiden, The Netherlands

Media Library

Edwards SAPIEN 3/ SAPIEN 3 Ultra (Transcatheter Heart Valve) Clinical Trial Eligibility Overview. Trial Name: NCT04889872 — N/A

Aortic Valve Stenosis Research Study Groups: TAVR, CS

Aortic Valve Stenosis Clinical Trial 2023: Edwards SAPIEN 3/ SAPIEN 3 Ultra Highlights & Side Effects. Trial Name: NCT04889872 — N/A

Edwards SAPIEN 3/ SAPIEN 3 Ultra (Transcatheter Heart Valve) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04889872 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are enrolled in the study at present?

"Affirmative. Clinicaltrials.gov contains evidence confirming that the clinical trial is actively enrolling participants, with its original posting date of October 12th 2021 and latest update on November 17th 2022. There are 50 sites recruiting a total of 750 patients for this research study."

Answered by AI

What is the ultimate outcome being sought from this trial?

"According to the sponsor, Edwards Lifesciences, this two year study aims to measure a composite of death, stroke and unplanned cardiovascular hospitalization. Secondary outcomes that will be observed include mortality rate, decrease in Kansas City Cardiomyopathy Questionnaire score, stroke volume index and frequency of unplanned cardiac admissions."

Answered by AI

Is this research currently looking for participants?

"That is correct. According to the clinicaltrials.gov data, this research trial began recruiting on October 12th 2021 and was recently updated November 17th 2022. It seeks 750 participants at 50 different sites around the country."

Answered by AI

Are there numerous locations conducting this experiment?

"This study is currently recruiting from a variety of locations, such as New york University Langone Medical Center in New York City, Sentara Norfolk General Hospital in Norfolk and Eisenhower Desert Cardiology Center located in Rancho Mirage. Additionally there are 50 other sites that have been selected for this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04889872.

All > Aortic Stenosis