Evaluating the MANTA Vascular Closure Device outcomes in TAVR procedures
Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes
This study is testing how well the MANTA Vascular Closure Device works for closing the access points in the leg after people have a TAVR heart procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Essential Medical, Inc. Industry-sponsored |
| Locations | 10 sites (Jacksonville, Florida and 9 other locations) |
| Trial ID | NCT05936996 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and clinical outcomes of the MANTA® Vascular Closure Device during transcatheter aortic valve replacement (TAVR) procedures. Participants undergoing TAVR will be enrolled to collect data on the effectiveness of the MANTA® device in closing femoral arterial access sites. The study will focus on appropriate patient selection and proper vascular access to ensure optimal outcomes. Data will be gathered from multiple sites across the U.S. and Canada, providing a comprehensive evaluation of the device's performance in real-world settings.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older who meet the criteria for on-label use of the MANTA® VCD.
Not a fit: Patients who are unable or unwilling to provide informed consent or complete follow-up assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and efficiency of femoral arteriotomy closure in TAVR procedures.
How similar studies have performed: Other studies evaluating vascular closure devices have shown promising results, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Candidate meets criteria for on-label use of MANTA® VCD as specified in the country-specific MANTA® VCD Instructions for Use (IFU), per judgement of the investigator. * Age ≥21 years Exclusion Criteria: * Unable or unwilling to give informed consent or unwilling to complete follow-up assessments.
Where this trial is running
Jacksonville, Florida and 9 other locations
- Baptist Health Medical Center-Jacksonville — Jacksonville, Florida, United States (Recruiting)
- Orlando Health, Inc — Orlando, Florida, United States (Recruiting)
- Henry Ford Health — Detroit, Michigan, United States (Recruiting)
- University at Buffalo — Buffalo, New York, United States (Recruiting)
- North Shore University Hospital — Manhasset, New York, United States (Recruiting)
- Mount Sinai Hospital — New York City, New York, United States (Recruiting)
- Montefiore Medical Center — New York, New York, United States (Not_yet_recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- Baylor Scott & White - Round Rock — Round Rock, Texas, United States (Recruiting)
- Montreal Heart Institute — Montréal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Darra Bigelow
- Email: darra.bigelow@teleflex.com
- Phone: 610-331-7299
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.