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New treatment option for Symptomatic Functional MR 3 or Greater
Official title AMEND TS Early Feasibility Study
ClinicalTrials.gov ID: NCT06951672
What this study is testing
- What it's testing
- Valcare Medical AMEND Trans-Septal System is a mitral valve repair annuloplasty ring implanted in a trans-catheter method intended for correction of mitral regurgitation. It is designed to be used as standalone therapy or in combination with other repair treatments.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- Patient age \>21
- The patient will benefit from isolated mitral valve annuloplasty for mitral regurgitation without the need for concomitant cardiovascular surgical...
- Symptomatic functional MR≥3+
- NYHA functional capacity ≥2
- LV Ejection Fraction \> 30%, LVEDD \< 68 mm
You likely can't join if
- The patient has mitral incompetence where an annuloplasty ring will not contribute to its repair
- Cardiac or non-cardiac major or progressive disease, which in the investigator's discretion produces an unacceptable increased risk to the patient.
- Life expectancy of less than 12 months
- The subject is non-operable and is not eligible for TEER, to allow bailout
- Heavily calcified mitral annulus or leaflets
- Previous or active endocarditis.
See the full eligibility criteria
- Patient age \>21
- The patient will benefit from isolated mitral valve annuloplasty for mitral regurgitation without the need for concomitant cardiovascular surgical procedures such as coronary artery bypass or another valve...
- Symptomatic functional MR≥3+
- NYHA functional capacity ≥2
- LV Ejection Fraction \> 30%, LVEDD \< 68 mm
- The subject meets the anatomical eligibility criteria for available implant size(s)
- The subject is at high risk for mitral valve surgery as assessed by the center's heart team for mitral procedures.
- The subject has been stable and on a stable pharmacological regimen for heart failure for at least 1 month prior to inclusion
- Femoral vein access and transseptal device access is determined to be feasible by the implanting investigator
- The patient is willing to comply with study procedures and is available to return to the implant center for follow-up visits
- Informed consent documentation signed and dated confirming that the patient has been adequately informed of all aspects related to his/her participation in the clinical study and is willing to participate.
- The patient has mitral incompetence where an annuloplasty ring will not contribute to its repair
- Cardiac or non-cardiac major or progressive disease, which in the investigator's discretion produces an unacceptable increased risk to the patient.
- Life expectancy of less than 12 months
- The subject is non-operable and is not eligible for TEER, to allow bailout
- Heavily calcified mitral annulus or leaflets
- Previous or active endocarditis.
- Active infection
- A previously implanted prosthetic aortic valve or mitral intervention
- Cardiovascular intervention within 30 days prior to study procedure
- GFR \<30 ml/min
- The patient has had an ischemic coronary event within 30 days prior to study procedure
- The patient has clinically significant coronary artery disease requiring re- vascularization
- The subject is contraindicated to general anesthesia
- The subject is unable to take anti-platelet or anti-coagulant medications
- A known allergy to nickel
- Severe allergy to contrast media
- Significant right ventricle dysfunction
- Left atrial thrombus
- A cerebral vascular event (CVA or TIA) within the past 12 months
- A mitral valve anatomy which may preclude proper AMEND™ treatment
- Pulmonary systolic hypertension (estimated SPAP \> 70 mmHg at rest), determined by echocardiography
- Pregnant (for women in the reproductive age, blood HCG test result positive) or lactating patient
- Drug or alcohol abuse
- Participation in concomitant research studies of investigational products
- Any planned cardiac surgery or interventions within the next 7 months
- Implant or revision of any rhythm management device (cardiac resynchronization therapy (CRT) or cardiac resynchronization therapy device (CRT-D)) or implantable cardioverter defibrillator within the prior month
- Hypotension (systolic pressure \<90 mm Hg) or requirement for inotropic support or mechanical hemodynamic support
- Status 1 heart transplantation or prior orthotopic heart transplantation
- people in whom transesophageal echocardiography is contraindicated or high risk
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- La Jolla, California, United States
- Atlanta, Georgia, United States
- Indianapolis, Indiana, United States
- New York, New York, United States
- The Bronx, New York, United States
- Portland, Oregon, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Murray, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; La Jolla, California, United States; Atlanta, Georgia, United States; Indianapolis, Indiana, United States; New York, New York, United States; The Bronx, New York, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.