NCT04820764ClinicalTrials.gov
EFS of the CardioMech MVRS
Early Feasibility Study of the CardioMech Mitral Valve Repair System (MVRS)
باختصار
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
تدخّليةمطلوب 25 مشاركاً12 موقعاًدولة واحدة
الفئات
مسجَّلة في سجل واحد
- ClinicalTrials.govNCT04820764فتح هذا السجل في ClinicalTrials.govتمت المزامنة قبل شهرين
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 2021-03-29; recorded start 2021-07-27
- 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: Participants are not randomly assignedAllocation is recorded as non-randomised
- Not stated: A comparison group is not stated in the registry recordThe record describes a single study arm
- Not stated: Open label (no blinding)Masking is recorded as none (open label)
- 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
- Not stated: No other studies from this sponsor are in this databaseCounted from the lead sponsor named in the record (CardioMech AS)
- Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
- The record lists 1 condition.
- 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
Open-label
- 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: 12 sites
- Data monitoring committee7/7
A data monitoring committee is in place
- Prospective registration5/5
Registered before the study start date
- Protocol / SAP posted0/5
No protocol or SAP posted to the registry
A pilot-scale study: 25 participants (target), run at 12 sites.
How this score is built
- Enrolment11/40
25 participants (target)
- Site count13/25
12 sites
- Country count0/15
Single country
- Planned duration10/10
Planned over about 123 months
- Sponsor scale0/10
CardioMech AS has led 1 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
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
الحالات
- Mitral Regurgitation
الأهلية
| الجنس | الجميع |
|---|---|
| الأعمار | 18 Years – لا حد أقصى |
| المتطوعون الأصحّاء | لا |
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 | تدخّلية |
|---|---|
| المرحلة | غير منطبق |
| التخصيص | غير منطبق |
| نموذج التدخّل | SINGLE_GROUP |
| الغرض الأساسي | DEVICE_FEASIBILITY |
| التعمية | NONE (0) |
| التجنيد | مطلوب 25 مشاركاً |
الجهة الراعية والمتعاونون
- CardioMech AS الجهة الراعية
الأذرع والتدخلات
- CardioMech Mitral Valve Repair System (MVRS)EXPERIMENTAL
التدخلات
- جهاز CardioMech MVRS
CardioMech MVRS
مقاييس النتائج
مقياس النتيجة الأولي
Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure
الإطار الزمني 30 days
مقياس النتيجة الأولي
Change in MR grade
الإطار الزمني 30 days
التواريخ
| تاريخ البدء | 27 يوليو 2021 (فعلي) |
|---|---|
| الإتمام الأولي | 1 سبتمبر 2026 (تقديري) |
| الإتمام | 1 سبتمبر 2031 (تقديري) |
| أول نشر | 29 مارس 2021 (فعلي) |
| آخر تحديث | 10 فبراير 2026 |
| النتائج منشورة | غير مذكور في سجل السجل |
| آخر تأكيد للحالة | يناير 2026 |
فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.
المواقع
10 مواقع قيد التجنيد
United States
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Atrium Health Sanger Heart and Vascular Institute | Charlotte | North Carolina | نشط، دون تجنيد |
| The Christ Hospital | Cincinnati | Ohio | قيد التجنيد |
| Cleveland Clinic | Cleveland | Ohio | قيد التجنيد |
| Northwestern University | Evanston | Illinois | قيد التجنيد |
| Intermountain Medical Center | Murray | Utah | قيد التجنيد |
| Ascension St. Thomas West | Nashville | Tennessee | قيد التجنيد |
| NYU Langone | New York | New York | قيد التجنيد |
| Baylor Scott & White, The Heart Hospital | Plano | Texas | قيد التجنيد |
| Mayo Clinic | Rochester | Minnesota | قيد التجنيد |
| CentraCare Heart & Vascular Center | Saint Cloud | Minnesota | قيد التجنيد |
| Cardiovascular Institute of Los Robles Health System | Thousand Oaks | California | نشط، دون تجنيد |
| Ascension St. Francis via Christi | Wichita | Kansas | قيد التجنيد |
مستندات الدراسة
لا تُرتبط أي مستندات في سجل السجل هذا.
التغيّرات عبر الزمن
لم تُسجَّل أي تغييرات منذ أن أدرجنا هذا السجل لأول مرة.
يُسجَّل تغيير في كل مرة تحدّث فيها الجهة الراعية سجل السجل. تظهر هنا الحالة والتواريخ والتجنيد والمواقع كلما تغيّرت.