NCT07069673ClinicalTrials.gov
Abbott Cephea Mitral Valve Disease Registry
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The objective of this registry is to gather clinical data on symptomatic patients with mitral valve disease, including patients with mitral regurgitation, mitral stenosis, and mixed mitral valve disease. Data collected from this registry are expected to improve our understanding…
Beobachtend1.000 Teilnehmende gesucht24 Studienzentren1 Land
Kategorien
In 1 Register registriert
- ClinicalTrials.govNCT07069673Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 2 Wochen
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How this study is set up
The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.
- Present: Registered before enrolment beganFirst posted 2025-07-17; recorded start 2025-08-13
- Present: Has a defined primary outcomeA primary outcome measure is listed in the record
- Present: The primary outcome states a time frameThe primary outcome measure records a time frame
- Not stated: Whether participants are randomly assigned is not stated in the registry recordNo allocation method is recorded
- Not stated: A comparison group is not stated in the registry recordThe record describes a single study arm
- Not stated: Whether the study is blinded is not stated in the registry recordNo masking information is recorded
- Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
- Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
- Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
- Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
- Present: Sponsor has 82 other studies in this databaseCounted from the lead sponsor named in the record (Abbott Medical Devices)
- Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
- The record lists 7 conditions.
- Lead sponsor type recorded as: industry.
Trial stature
Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.
An exploratory-stage design for a study of this type, judged from its ClinicalTrials.gov record.
How this score is built
- Randomised allocation0/20
Allocation not stated in the record
- Blinding0/20
Masking not stated in the record
- Control arm0/15
No comparator arm stated in the record
- Primary-outcome specificity10/10
Named primary outcome with a defined time frame
- Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
- Multi-centre8/8
Multi-centre: 23 sites
- Data monitoring committee0/7
No data monitoring committee stated
- Prospective registration5/5
Registered before the study start date
- Protocol / SAP posted0/5
No protocol or SAP posted to the registry
A large study: 1,000 participants (target), run at 24 sites.
How this score is built
- Enrolment30/40
1,000 participants (target)
- Site count16/25
23 sites
- Country count0/15
Single country
- Planned duration8/10
Planned over about 40 months
- Sponsor scale7/10
Abbott Medical Devices has led 83 trials in our corpus
We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.
How this score is built
- Investigator standing0/100
No investigator recorded in the registry for this trial
These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.
Zusammenfassung
The objective of this registry is to gather clinical data on symptomatic patients with mitral valve disease, including patients with mitral regurgitation, mitral stenosis, and mixed mitral valve disease. Data collected from this registry are expected to improve our understanding of the impact of correcting symptomatic mitral valve disease on clinical outcomes in patients that could be candidates for Transcatheter Mitral Valve Replacement and may also inform future regulatory or reimbursement submission strategies for the Cephea Mitral Valve System.
Erkrankungen
- Mitral Regurgitation
- Mitral Stenosis
- Mitral Valve Disease
- Mitral Valve (MV) Regurgitation
- Mitral Annulus Calcification
- Mitral Valve Replacement
- Transcatheter Valve Replacement
Eignung
| Geschlecht | Alle |
|---|---|
| Alter | 18 Years – Kein Höchstalter |
| Gesunde Freiwillige | Nein |
| Stichprobenverfahren | NON_PROBABILITY_SAMPLE |
Studienpopulation
This registry will enroll subjects over 18 years of age of all genders with symptomatic mitral valve disease including those with mitral regurgitation, mitral stenosis, and mixed mitral valve disease, who are candidates for transcatheter mitral valve replacement.
Eignung im Wortlaut des Registers
Eignung in einfachen Aussagen
Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.
Studiendesign
| Studientyp | Beobachtend |
|---|---|
| Phase | Im Registereintrag nicht angegeben |
| Zuteilung | Im Registereintrag nicht angegeben |
| Interventionsmodell | Im Registereintrag nicht angegeben |
| Primäres Ziel | Im Registereintrag nicht angegeben |
| Verblindung | Im Registereintrag nicht angegeben |
| Teilnahme | 1.000 Teilnehmende gesucht |
Sponsor und Mitwirkende
- Abbott Medical Devices Sponsor
Studienarme und Interventionen
- Potential transcatheter mitral valve replacement (TMVR) candidates
Patients with symptomatic mitral valve disease who may be candidates for transcatheter mitral valve replacement.
Endpunkte
Primärer Endpunkt
Primary Objective
The objective of the MVD Registry is to collect data on the progression of MVD patients considered for TMVR therapy to guide product development, regulatory submissions, and reimbursement planning
Zeitrahmen From enrollment to 2 years of follow-up
Daten
| Startdatum | 13. August 2025 (tatsächlich) |
|---|---|
| Primärer Abschluss | 1. Dezember 2028 (geschätzt) |
| Abschluss | 1. Dezember 2028 (geschätzt) |
| Erstveröffentlichung | 17. Juli 2025 (tatsächlich) |
| Zuletzt aktualisiert | 10. September 2026 |
| Ergebnisse veröffentlicht | Im Registereintrag nicht angegeben |
| Status zuletzt bestätigt | Juni 2026 |
Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.
Standorte
24 Studienzentren rekrutieren
United States
| Einrichtung | Stadt | Bundesland oder Region | Status |
|---|---|---|---|
| Piedmont Heart Institute | Atlanta | Georgia | Rekrutiert |
| Emory University Hospital | Atlanta | Georgia | Rekrutiert |
| University Hospital - Univ. of Alabama at Birmingham (UAB) | Birmingham | Alabama | Rekrutiert |
| Medical University of South Carolina | Charleston | South Carolina | Rekrutiert |
| Atrium Health - Carolinas Medical Center | Charlotte | North Carolina | Rekrutiert |
| Northwestern Memorial Hospital | Chicago | Illinois | Rekrutiert |
| The Cleveland Clinic Foundation | Cleveland | Ohio | Rekrutiert |
| Houston Methodist | Houston | Texas | Rekrutiert |
| UTHealth Memorial Hermann | Houston | Texas | Rekrutiert |
| Ascension St. Vincent | Indianapolis | Indiana | Rekrutiert |
| Minneapolis Heart Institute | Minneapolis | Minnesota | Rekrutiert |
| Providence St. Patrick Hospital | Missoula | Montana | Rekrutiert |
| Intermountain Medical Center | Murray | Utah | Rekrutiert |
| Ascension Saint Thomas | Nashville | Tennessee | Rekrutiert |
| Vanderbilt Heart & Vascular Institute | Nashville | Tennessee | Rekrutiert |
| TriStar Centennial Medical Center | Nashville | Tennessee | Rekrutiert |
| Sentara Norfolk General Hospital | Norfolk | Virginia | Rekrutiert |
| Banner-University Medical Center Phoenix | Phoenix | Arizona | Rekrutiert |
| Phoenix Cardiovascular Research Group | Phoenix | Arizona | Rekrutiert |
| Allegheny General Hospital - ASRI | Pittsburgh | Pennsylvania | Rekrutiert |
| St. Francis Hospital | Roslyn | New York | Rekrutiert |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | Rekrutiert |
| Los Robles Regional Medical Center | Thousand Oaks | California | Rekrutiert |
| Ascension Via Christi Hospitals Wichita | Wichita | Kansas | Rekrutiert |
Studiendokumente
In diesem Registereintrag sind keine Dokumente verlinkt.
Änderungen im Zeitverlauf
- 10. September 2026
Studienzentrum hinzugefügt
1 site added (24 total)
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