NCT07069673ClinicalTrials.gov
Abbott Cephea Mitral Valve Disease Registry
باختصار
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…
رصديةمطلوب 1,000 مشارك24 موقعاًدولة واحدة
الفئات
مسجَّلة في سجل واحد
- ClinicalTrials.govNCT07069673فتح هذا السجل في ClinicalTrials.govتمت المزامنة قبل أسبوعين
يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.
تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.
هل أنت مهتم بهذه الدراسة؟
تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.
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.
ملخص
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.
الحالات
- Mitral Regurgitation
- Mitral Stenosis
- Mitral Valve Disease
- Mitral Valve (MV) Regurgitation
- Mitral Annulus Calcification
- Mitral Valve Replacement
- Transcatheter Valve Replacement
الأهلية
| الجنس | الجميع |
|---|---|
| الأعمار | 18 Years – لا حد أقصى |
| المتطوعون الأصحّاء | لا |
| طريقة أخذ العينات | NON_PROBABILITY_SAMPLE |
مجتمع الدراسة
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.
الأهلية كما كُتبت في السجل
الأهلية في عبارات بسيطة
لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.
تصميم الدراسة
| نوع الدراسة | رصدية |
|---|---|
| المرحلة | غير مذكور في سجل السجل |
| التخصيص | غير مذكور في سجل السجل |
| نموذج التدخّل | غير مذكور في سجل السجل |
| الغرض الأساسي | غير مذكور في سجل السجل |
| التعمية | غير مذكور في سجل السجل |
| التجنيد | مطلوب 1,000 مشارك |
الجهة الراعية والمتعاونون
- Abbott Medical Devices الجهة الراعية
الأذرع والتدخلات
- Potential transcatheter mitral valve replacement (TMVR) candidates
Patients with symptomatic mitral valve disease who may be candidates for transcatheter mitral valve replacement.
مقاييس النتائج
مقياس النتيجة الأولي
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
الإطار الزمني From enrollment to 2 years of follow-up
التواريخ
| تاريخ البدء | 13 أغسطس 2025 (فعلي) |
|---|---|
| الإتمام الأولي | 1 ديسمبر 2028 (تقديري) |
| الإتمام | 1 ديسمبر 2028 (تقديري) |
| أول نشر | 17 يوليو 2025 (فعلي) |
| آخر تحديث | 10 سبتمبر 2026 |
| النتائج منشورة | غير مذكور في سجل السجل |
| آخر تأكيد للحالة | يونيو 2026 |
فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.
المواقع
24 موقعاً قيد التجنيد
United States
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Piedmont Heart Institute | Atlanta | Georgia | قيد التجنيد |
| Emory University Hospital | Atlanta | Georgia | قيد التجنيد |
| University Hospital - Univ. of Alabama at Birmingham (UAB) | Birmingham | Alabama | قيد التجنيد |
| Medical University of South Carolina | Charleston | South Carolina | قيد التجنيد |
| Atrium Health - Carolinas Medical Center | Charlotte | North Carolina | قيد التجنيد |
| Northwestern Memorial Hospital | Chicago | Illinois | قيد التجنيد |
| The Cleveland Clinic Foundation | Cleveland | Ohio | قيد التجنيد |
| Houston Methodist | Houston | Texas | قيد التجنيد |
| UTHealth Memorial Hermann | Houston | Texas | قيد التجنيد |
| Ascension St. Vincent | Indianapolis | Indiana | قيد التجنيد |
| Minneapolis Heart Institute | Minneapolis | Minnesota | قيد التجنيد |
| Providence St. Patrick Hospital | Missoula | Montana | قيد التجنيد |
| Intermountain Medical Center | Murray | Utah | قيد التجنيد |
| Ascension Saint Thomas | Nashville | Tennessee | قيد التجنيد |
| Vanderbilt Heart & Vascular Institute | Nashville | Tennessee | قيد التجنيد |
| TriStar Centennial Medical Center | Nashville | Tennessee | قيد التجنيد |
| Sentara Norfolk General Hospital | Norfolk | Virginia | قيد التجنيد |
| Banner-University Medical Center Phoenix | Phoenix | Arizona | قيد التجنيد |
| Phoenix Cardiovascular Research Group | Phoenix | Arizona | قيد التجنيد |
| Allegheny General Hospital - ASRI | Pittsburgh | Pennsylvania | قيد التجنيد |
| St. Francis Hospital | Roslyn | New York | قيد التجنيد |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | قيد التجنيد |
| Los Robles Regional Medical Center | Thousand Oaks | California | قيد التجنيد |
| Ascension Via Christi Hospitals Wichita | Wichita | Kansas | قيد التجنيد |
مستندات الدراسة
لا تُرتبط أي مستندات في سجل السجل هذا.
التغيّرات عبر الزمن
- 10 سبتمبر 2026
أُضيف موقع
1 site added (24 total)
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