← Back to Search

Prosthetic Valve

Cardiovalve for Mitral Valve Regurgitation (AHEAD Trial)

N/A
Waitlist Available
Research Sponsored by Boston Biomedical Associates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient deemed a high surgical risk per MVARC definition by the site's Heart Team (as a minimum, one MV cardiac surgeon and one interventional cardiologist, and a cardiac imaging expert)
Cardiac Index greater than 2.0
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days, 3 months, 6 months
Awards & highlights

AHEAD Trial Summary

This trial is testing a new device to stop mitral valve regurgitation. The device will be evaluated for safety and performance over 30 days and 5 years.

Who is the study for?
This trial is for adults aged 18-85 with severe symptomatic mitral valve regurgitation who are high surgical risks and have a cardiac index over 2.0. They must have been treated for heart failure for at least 30 days, not had previous mitral valve surgery, and can't be pregnant or in another study.Check my eligibility
What is being tested?
The Cardiovalve Transfemoral Mitral Valve System is being tested to see if it safely reduces mitral regurgitation. The trial will assess the device's performance after implantation through the leg vein (transfemorally) and track patients' health outcomes over five years.See study design
What are the potential side effects?
Potential side effects may include complications related to heart procedures such as bleeding, infection risk from the procedure, possible allergic reactions to materials in the device or medications used during implantation, and any impacts on kidney function.

AHEAD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My doctors consider me a high risk for heart surgery.
Select...
My heart pumps blood effectively.
Select...
My heart condition limits my physical activity but I can still take care of myself.
Select...
I have been on heart failure medication as per guidelines for over 30 days.
Select...
My heart valve problem is severe and causes symptoms.
Select...
I am between 18 and 85 years old.
Select...
My heart pumps well, with an LVEF of 30% or higher.

AHEAD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days, 3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cardiovalve Technical Success
Cardiovalve to be implanted without Major Device Related Adverse Events through 30 Days including
Secondary outcome measures
6-minute walk test (6MWT) distance
Change in LV end diastolic volume index (LVEDVI)
Change in LV end systolic volume index (LVESVI)
+4 more

AHEAD Trial Design

1Treatment groups
Experimental Treatment
Group I: Cardiovalve Transfemoral Mitral ValveExperimental Treatment1 Intervention
Replacement valve delivered through a transfemoral access and transseptal approach

Find a Location

Who is running the clinical trial?

Boston Biomedical AssociatesLead Sponsor
8 Previous Clinical Trials
350 Total Patients Enrolled
Cardiovalve Ltd.Industry Sponsor
5 Previous Clinical Trials
155 Total Patients Enrolled
Cardiovascular Research Foundation, New YorkOTHER
24 Previous Clinical Trials
26,732 Total Patients Enrolled

Media Library

Cardiovalve Transfemoral Mitral Valve System (Prosthetic Valve) Clinical Trial Eligibility Overview. Trial Name: NCT03813524 — N/A
Mitral Valve Regurgitation Research Study Groups: Cardiovalve Transfemoral Mitral Valve
Mitral Valve Regurgitation Clinical Trial 2023: Cardiovalve Transfemoral Mitral Valve System Highlights & Side Effects. Trial Name: NCT03813524 — N/A
Cardiovalve Transfemoral Mitral Valve System (Prosthetic Valve) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03813524 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant capacity of this trial?

"Affirmative. Clinicaltrials.gov corroborates that this investigation is currently recruiting patients, which was first posted on March 26th 2019 and recently revised on July 28th 2021. 15 individuals must be recruited from two distinct clinical sites."

Answered by AI

To whom does this clinical trial extend an invitation?

"This clinical trial is enrolling 15 individuals aged 18 to 84 who suffer from mitral valve insufficiency. Other requirements include a cardiac index greater than 2.0, an NYHA Functional Class between II-IVa, prior treatment with GDMT for heart failure in the preceding 30 days and being classified as high surgical risk by the Heart Team (minimum two MV cardiac surgeons, one interventional cardiologist, and one imaging expert)."

Answered by AI

Is the current trial inclusive of elderly individuals over 75 years old?

"The lower age limit for qualification into this trial is 18, while the upper bound cutoff sits at 84."

Answered by AI

Are there any opportunities still available for participants in this clinical examination?

"Indeed, according to clinicaltrials.gov, this medical research project is presently accepting applicants. It was first launched on March 26 2019 and has seen its last update on July 28 2021. There are 15 places open at 2 locations."

Answered by AI
~7 spots leftby Jun 2028