NCT07069673ClinicalTrials.gov

Abbott Cephea Mitral Valve Disease Registry

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.

Contatta questo studio

In breve

Osservazionale1000 partecipanti ricercati24 centri1 paese

Categorie

Cardiovascolare87%Gastroenterologia ed epatologia13%

Registrato in 1 registro

ClinicalTrials.govNCT07069673Apri questa scheda su ClinicalTrials.govSincronizzato 2 settimane fa

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Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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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.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

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.

Methodological rigourEXPLORATORY

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

ScaleLARGE

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

Investigator standingUNKNOWN

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.

Sintesi

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.

Patologie

Mitral Regurgitation
Mitral Stenosis
Mitral Valve Disease
Mitral Valve (MV) Regurgitation
Mitral Annulus Calcification
Mitral Valve Replacement
Transcatheter Valve Replacement

Idoneità

Idoneità
Sesso	Tutti
Età	18 Years – Nessun massimo
Volontari sani	No
Metodo di campionamento	NON_PROBABILITY_SAMPLE

Popolazione dello studio

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.

Idoneità come riportata nel registro

Inclusion Criteria: 1. Symptomatic mitral valve disease resulting in mitral regurgitation and/or severe mitral valve stenosis. 2. New York Heart Association (NYHA) Functional Class II, III, or ambulatory IV. 3. In the judgement of the Site Heart Team, transcatheter therapy is deemed to be more appropriate than conventional mitral valve surgery, TMVR is more likely to provide an optimal result than TEER, and the subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, and heart failure. 4. Age 18 years or older at time of consent. 5. The subject agrees to the study requirements, permits all follow-up data entry, and has provided written informed consent. Exclusion Criteria: 1. Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function. 2. Subject is undergoing dialysis or experiencing chronic renal failure 3. Subject has chronic lung disease requiring continuous home oxygen therapy or chronic outpatient oral steroid use 4. Subjects with comorbidities that are likely to result in a life expectancy of less than 12 months. 5. Pregnant or nursing subjects and those who plan pregnancy during the follow-up period.

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Disegno dello studio
Tipo di studio	Osservazionale
Fase	Non indicato nella scheda del registro
Assegnazione	Non indicato nella scheda del registro
Modello di intervento	Non indicato nella scheda del registro
Finalità principale	Non indicato nella scheda del registro
Mascheramento	Non indicato nella scheda del registro
Arruolamento	1000 partecipanti ricercati

Sponsor e collaboratori

Abbott Medical Devices Sponsor

Bracci e interventi

Potential transcatheter mitral valve replacement (TMVR) candidates
Patients with symptomatic mitral valve disease who may be candidates for transcatheter mitral valve replacement.

Esiti misurati

Esito primario
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
Orizzonte temporale From enrollment to 2 years of follow-up

Date

Date
Data di inizio	13 agosto 2025 (effettiva)
Conclusione primaria	1 dicembre 2028 (stimata)
Conclusione	1 dicembre 2028 (stimata)
Prima pubblicazione	17 luglio 2025 (effettiva)
Ultimo aggiornamento	10 settembre 2026
Risultati pubblicati	Non indicato nella scheda del registro
Stato verificato l'ultima volta	giugno 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

24 centri stanno reclutando

United States

United States
Struttura	Città	Stato o regione	Stato
Piedmont Heart Institute	Atlanta	Georgia	In reclutamento
Emory University Hospital	Atlanta	Georgia	In reclutamento
University Hospital - Univ. of Alabama at Birmingham (UAB)	Birmingham	Alabama	In reclutamento
Medical University of South Carolina	Charleston	South Carolina	In reclutamento
Atrium Health - Carolinas Medical Center	Charlotte	North Carolina	In reclutamento
Northwestern Memorial Hospital	Chicago	Illinois	In reclutamento
The Cleveland Clinic Foundation	Cleveland	Ohio	In reclutamento
Houston Methodist	Houston	Texas	In reclutamento
UTHealth Memorial Hermann	Houston	Texas	In reclutamento
Ascension St. Vincent	Indianapolis	Indiana	In reclutamento
Minneapolis Heart Institute	Minneapolis	Minnesota	In reclutamento
Providence St. Patrick Hospital	Missoula	Montana	In reclutamento
Intermountain Medical Center	Murray	Utah	In reclutamento
Ascension Saint Thomas	Nashville	Tennessee	In reclutamento
Vanderbilt Heart & Vascular Institute	Nashville	Tennessee	In reclutamento
TriStar Centennial Medical Center	Nashville	Tennessee	In reclutamento
Sentara Norfolk General Hospital	Norfolk	Virginia	In reclutamento
Banner-University Medical Center Phoenix	Phoenix	Arizona	In reclutamento
Phoenix Cardiovascular Research Group	Phoenix	Arizona	In reclutamento
Allegheny General Hospital - ASRI	Pittsburgh	Pennsylvania	In reclutamento
St. Francis Hospital	Roslyn	New York	In reclutamento
Montefiore Medical Center - Moses Campus	The Bronx	New York	In reclutamento
Los Robles Regional Medical Center	Thousand Oaks	California	In reclutamento
Ascension Via Christi Hospitals Wichita	Wichita	Kansas	In reclutamento

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

10 settembre 2026
Centro aggiunto
1 site added (24 total)
2324

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07069673