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Comparison Between Manta and Prostar Closure Devices

NCT ID: NCT05662748

Last Updated: 2022-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-20

Study Completion Date

2021-03-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Aortic Valve Stenosis

Keywords

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Closure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Pro Star

patient received Pro Star Device

Transfemoral aortic valve replacement

Intervention Type DEVICE

aortic valve replacement

MANTA

Patient received MANTA Device

Transfemoral aortic valve replacement

Intervention Type DEVICE

aortic valve replacement

Interventions

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Transfemoral aortic valve replacement

aortic valve replacement

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

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Jörg Schröder

PD Dr. med Jörg Schröder

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jörg Schröder

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Aachen Medizinische Klinik 1

Michael Lehrke

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Aachen Medizinische Klinik 1

Locations

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Universitätsklinikum Aachen

Aachen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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RWTH AachenU

Identifier Type: -

Identifier Source: org_study_id