Optimize PRO Study
Public ClinicalTrials.gov record NCT04091048. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
Optimize PRO Transcatheter Aortic Valve Replacement Post Market Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to collect clinical evidence on valve performance and procedural outcomes associated with an "optimized" TAVR care pathway and post-TAVR conduction disturbance pathway while using the Evolut™ PRO and Evolut™ PRO+ devices. The purpose of the addendum is to collect post-market clinical evidence on valve performance and procedural outcomes associated with the Evolut FX Device.
Study identification
- NCT ID
- NCT04091048
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 1,127 participants
Conditions and interventions
Conditions
Interventions
Device
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 16, 2019 (Actual)
- Primary completion
- Dec 15, 2023 (Actual)
- Completion
- Nov 13, 2024 (Actual)
- Last update posted
- Jan 13, 2026
2019 – 2024
United States locations
- U.S. sites
- 37
- U.S. states
- 20
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham Hospital | Birmingham | Alabama | 35233 | — |
| California Pacific Medical Center - Sutter Health | San Francisco | California | 94109 | — |
| Hartford Hospital | Hartford | Connecticut | 06102 | — |
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | — |
| St. Vincent's Hospital / Cardiology Associates of Fairfield County, P.C. | Norwalk | Connecticut | 06851 | — |
| Morton Plant Hospital | Clearwater | Florida | 33756 | — |
| Emory University Hospital | Atlanta | Georgia | 30308 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| St. John's Hospital/Prarie Education and Research Cooperative | Springfield | Illinois | 62769 | — |
| Medstar Union Memorial Hospital | Baltimore | Maryland | 21218 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Ascension St. John Hospital | Detroit | Michigan | 48236 | — |
| Spectrum Health | Grand Rapids | Michigan | 49503 | — |
| Abbott Northwestern Hospital (Minneapolis Heart) | Minneapolis | Minnesota | 55407 | — |
| Providence St. Patrick Hospital | Missoula | Montana | 59802 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68105 | — |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | — |
| The Valley Hospital | Ridgewood | New Jersey | 07450 | — |
| Buffalo General Medical Center | Buffalo | New York | 14203 | — |
| The Mount Sinai Hospital | New York | New York | 10029 | — |
| New York Presbyterian - Columbia University Medical Center | New York | New York | 10032 | — |
| Vassar Brother's Medical Center | Poughkeepsie | New York | 12601 | — |
| St. Francis Hospital | Roslyn | New York | 11576 | — |
| Stony Brook University Hospital | Stony Brook | New York | 11794 | — |
| Ohio Health Research Institute | Columbus | Ohio | 43214 | — |
| Kettering Medical Center | Kettering | Ohio | 45429 | — |
| Lehigh Valley Hospital - Cedar Crest | Allentown | Pennsylvania | 18103 | — |
| UPMC Pinnacle Harrisburg | Harrisburg | Pennsylvania | 17101 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| UPMC Presbyterian | Pittsburgh | Pennsylvania | 15213 | — |
| York Hospital | York | Pennsylvania | 17403 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| The Heart Hospital - Baylor Plano | Plano | Texas | 75093 | — |
| Dixie Regional Medical Center Intermountain | St. George | Utah | 84770 | — |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | — |
| Charleston Medical Center | Charleston | West Virginia | 25304 | — |
| Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | 53125 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04091048, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 13, 2026 · Synced Nov 7, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04091048 live on ClinicalTrials.gov.