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NCT05936996 | RECRUITING | Femoral Arteriotomy Closure

Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes
Sponsor:

Essential Medical, Inc.

Brief Summary:

This is an observational study designed to evaluate the safety and clinical outcomes of the MANTA® Vascular Closure Device (VCD) (the MANTA® Device) in TAVR procedures. The study will enroll participants who are undergoing a TAVR procedure. The purpose of this study is to examine and collect data on outcomes of contemporary MANTA® large bore closure in standard of care (SOC) TAVR procedures with on-label use of the MANTA® device including appropriate patient selection and proper vascular access.

Condition or disease

Femoral Arteriotomy Closure

Intervention/treatment

MANTA Vascular Closure Device

Detailed Description:

In the U.S. and Canada, the MANTA® Vascular Closure Device is indicated for closure of femoral arterial access sites while reducing time to hemostasis following the use of 10-20F devices or sheaths (12-25F OD) in endovascular catheterization procedures. In Israel, the 14F MANTA® is indicated for closure of femoral arterial access sites following the use of 10-14F devices or sheaths (maximum OD/profile of 18F), and the 18F MANTA® device is indicated for closure of femoral arterial access sites following the use of 15-18F devices or sheaths (maximum OD/profile of 25F). The purpose of the study is to examine and collect data on outcomes of contemporary MANTA® large bore closure in standard of care (SOC) TAVR procedures with on-label use of the MANTA® device including appropriate patient selection and proper vascular access.

Study Type : OBSERVATIONAL
Estimated Enrollment : 250 participants
Official Title : Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes
Actual Study Start Date : 2023-11-15
Estimated Primary Completion Date : 2025-07-31
Estimated Study Completion Date : 2025-07-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes

Location Details

NCT05936996

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

Baptist Health Medical Center-Jacksonville

Jacksonville, Florida, United States, 32207

RECRUITING

United States, Florida

Orlando Health, Inc

Orlando, Florida, United States, 32806

RECRUITING

United States, Road cancer

Henry Ford Health

Detroit, Road cancer, United States, 48202

RECRUITING

United States, New York

University at Buffalo

Buffalo, New York, United States, 14203

RECRUITING

United States, New York

North Shore University Hospital

Manhasset, New York, United States, 11030

RECRUITING

United States, New York

Mount Sinai Hospital

New York, New York, United States, 10029

NOT YET RECRUITING

United States, New York

Montefiore Medical Center

New York, New York, United States, 10467

RECRUITING

United States, Tennessee

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

RECRUITING

United States, Texas

Baylor Scott & White - Round Rock

Round Rock, Texas, United States, 78665

RECRUITING

Canada, Quebec

Montreal Heart Institute

Montreal, Quebec, Canada, H1T 1C8