Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes (ACCESS MANTA)

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.

Study Overview

• Status: Recruiting
• Conditions: Femoral Arteriotomy Closure
• Intervention / Treatment: Device: 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
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Farah Jarjous; Phone Number: +1.734.309.1312; Email: farah.jarjous@teleflex.com
• Study Contact Backup: Name: Darra Bigelow; Phone Number: +1.610.331.7299; Email: darra.bigelow@teleflex.com

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Recruiting
      • Baptist Health Medical Center-Jacksonville
      • Principal Investigator: Siddharth Wayangankar, MD
      • Contact: Doran Cassidy
      • Sub-Investigator: Ruby Satpathy, MD
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Health
      • Sub-Investigator: Brian O'Neill, MD
      • Contact: Danielle Holmes
      • Principal Investigator: Pedro Villablanca, MD
      • Sub-Investigator: Pedro Engel Gonzalez, MD
  • New York
    • Buffalo, New York, United States, 14203
      • Not yet recruiting
      • University at Buffalo
      • Principal Investigator: Vijay Iyer, MD
      • Contact: Kennedy Whitley
      • Sub-Investigator: Christopher Manion, MD
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai Hospital
      • Contact: Armandi Smith
      • Principal Investigator: Sahil Khera, MD
      • Sub-Investigator: George Dangas, MD
      • Sub-Investigator: Gilbert Tang, MD
  • Texas
    • Round Rock, Texas, United States, 78665
      • Recruiting
      • Baylor Scott & White - Round Rock
      • Contact: Theresa Quezada
      • Principal Investigator: Angel Caldera, MD
      • Sub-Investigator: Jose Contreras Condado, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Qualifying subjects undergoing TAVR using the MANTA® VCD for large bore closure.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of VARC-3 Major & Minor Vascular complications		within 30 days of TAVR procedure
Time to Hemostasis	The elapsed time between MANTA® deployment and first observed and confirmed arterial hemostasis	During the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional interventions: Required at large bore access site to address complications	The percentage of subjects with additional interventions required at large bore access site to address bleeding or other large bore access site complications (e.g., bare or covered stent or surgical repair), within 30 days following the procedure	within 30 days following the procedure
Technical Success:	The percentage of subjects in whom closure is obtained with the MANTA® VCD without the use of unplanned endovascular or surgical intervention	During the procedure
Treatment Success:	The percentage of subjects in whom the time to Hemostasis ≤10 minutes and have no Large Bore Access Related Major VARC-3 complications within 30 days.	within 30 days of TAVR procedure
Ambulation Success:	The percentage of a previously ambulatory subjects (until day of TAVI) who are able to ambulate for at least 20 feet/6 meters without re-bleeding.	During procedure admission

Collaborators and Investigators

• Sponsor: Essential Medical, Inc.
• Collaborators: Essential Medical LLC a subsidiary of Teleflex, Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: June 16, 2023
• First Submitted That Met QC Criteria: June 29, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: MANTA; Arterial Closure Device; Large Bore Closure Device
• Other Study ID Numbers: ST-3659

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data obtained will be used, without mentioning Subject PHI, to assess the results of the research, and the data could be used in the future with regard to this study or other studies. The data can be passed on to the health authorities for the purposes of registering the medical device.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes