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Transcatheter Heart Valve

TAVR for Aortic Valve Stenosis(PROGRESS Trial)

Baptist Health Research Center, Jacksonville, FL
Targeting 2 different conditionsSAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIAN/ARecruitingLed by Raj Makkar, MDResearch Sponsored by Edwards Lifesciences

PROGRESS Trial Summary

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

Eligible Conditions
  • Aortic Valve Stenosis
  • Calcific Aortic Stenosis

PROGRESS Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You are 65 years old or older when the study starts.
You have moderate aortic stenosis.
You have signs of heart damage or problems with how your heart works.

PROGRESS Trial Timeline

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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)

Find a Location

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor
174 Previous Clinical Trials
58,888 Total Patients Enrolled
60 Trials studying Aortic Valve Stenosis
30,115 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
Philippe Généreux, MDPrincipal InvestigatorMorristown Medical Center, Morristown, NJ, USA
4 Previous Clinical Trials
3,360 Total Patients Enrolled
1 Trials studying Aortic Valve Stenosis
901 Patients Enrolled for Aortic Valve Stenosis

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, 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 Cardiologys 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
~500 spots leftby Jun 2029