COMPLETED

Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes

Quick Facts

Study Start:2023-11-15
Study Completion:2025-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05936996

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Age ≥21 years
  1. * Unable or unwilling to give informed consent or unwilling to complete follow-up assessments.

Contacts and Locations

Study Locations (Sites)

Baptist Health Medical Center-Jacksonville
Jacksonville, Florida, 32207
United States
Orlando Health, Inc
Orlando, Florida, 32806
United States
Henry Ford Health
Detroit, Michigan, 48202
United States
University at Buffalo
Buffalo, New York, 14203
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Mount Sinai Hospital
New York, New York, 10029
United States
Montefiore Medical Center
New York, New York, 10467
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Baylor Scott & White - Round Rock
Round Rock, Texas, 78665
United States

Collaborators and Investigators

Sponsor: Essential Medical, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-15
Study Completion Date2025-10-30

Study Record Updates

Study Start Date2023-11-15
Study Completion Date2025-10-30

Terms related to this study

Keywords Provided by Researchers

  • MANTA
  • Arterial Closure Device
  • Large Bore Closure Device

Additional Relevant MeSH Terms

  • Femoral Arteriotomy Closure