Comparison Between Manta and Prostar Closure Devices

Use of the Closure Device in Patient With Percutaneous Transfemoral Aortic Valve Replacement

Use of the closure device in patient with percutaneous transfemoral aortic valve replacement

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Transfemoral aortic valve replacement

Detailed Description

The advent of endovascular, transcatheter aortic valve replacement (TAVR), and mechanical circulatory support has offered new, minimally invasive therapeutic options that are rapidly becoming standard of care. These percutaneous transfemoral interventions require large-bore catheters and have created challenges for femoral arterial access management. Current approaches include surgical cut-down with arterial puncture under direct vision, and suture-based "pre-closure." Surgical cut-down is associated with longer procedural time, increased patient discomfort, deeper anesthesia, risk of wound complications including infection, and slower ambulation. The pre-closure technique overcomes many of the disadvantages of surgical cut-down but can be technically demanding, time consuming, and associated with a significant failure rate. Recent randomized TAVR trials have reported major vascular complications in 6% to 8% . Furthermore, a study on the 2 suture-based closure techniques for management of TAVR access reported a 20% vascular complication rate despite being used by experienced operators . Currently, the majority of access site complications result from failed arteriotomy closure . The percutaneous MANTA Vascular Closure Device (VCD) (Essential Medical Inc., Malvern, Pennsylvania) is a novel collagen-based technology dedicated to closure of largebore arteriotomies . The MANTA VCD underwent prospective multicenter evaluation for Conformitä Europäenne (CE) mark approval in the first detailed report of outcomes achieved with a dedicated large-bore vascular closure device Contrary to the aforementioned TAVR procedures, mechanical circulatory support therapy can be extended up to several days on the intensive care ward. Data on such delayed closure with is lacking. This registry is therefore aimed to document the initial experiences of delayed closure of a femoral large bore access with vascular closure devices in patients with an TAVR device.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Aachen, NRW, Germany, 52074
      • Universitätsklinikum Aachen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with planned treatment of aortic valve replacement will be asked to participate in the observational study

Description

Inclusion Criteria:

• Patient scheduled for treatment with the TAVR device 2. Decision to use the Manta or the Prostar closure device on a clinical base by the treating physician 3. Signed informed consent

Exclusion Criteria:

• Male or female aged < 18 2. Pregnant and lactating females 3. Patient has been committed to an institution by legal or regulatory order

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pro Star; patient received Pro Star Device	Device: Transfemoral aortic valve replacement; aortic valve replacement
MANTA; Patient received MANTA Device	Device: Transfemoral aortic valve replacement; aortic valve replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety endpoints during index hospitalisation	Major vascular complications,	2018 - 2020
Safety endpoints during index hospitalisation ( bleeding)	life-threatining-, major bleeding	2018-2020
Safety endpoints during index hospitalisation ( death )	death	2018-2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy endpoints during index hospitalisation - (hemotasis)	hemotasis in angiogram	2018-2020
efficacy endpoints during index hospitalisation ( device failure)	device failure	2018-2020
efficacy endpoints during index hospitalisation ( bail-out )	need for stent-graft	2018-2020

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
preperation time	preperation time for closure	2018-2020

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Principal Investigator: Jörg Schröder, Universitätsklinikum Aachen Medizinische Klinik 1; Principal Investigator: Michael Lehrke, Universitätsklinikum Aachen Medizinische Klinik 1

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2020
• Primary Completion (Actual): March 30, 2021
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: December 15, 2022
• First Posted (Estimate): December 22, 2022

Study Record Updates

• Last Update Posted (Estimate): December 22, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Closure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: RWTH AachenU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Study results will be published in an appropriate scientific journal. The Ethics Committee will be informed about the study results.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No