Comparison Between Manta and Prostar Closure Devices

Aortic Valve Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05662748
• Other study ID #: RWTH AachenU
• Status: Completed
• Start date: January 20, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: December 2022
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• Transfemoral aortic valve replacement
aortic valve replacement

Locations

Country	Name	City	State
Germany	Universitätsklinikum Aachen	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	preperation time	preperation time for closure	2018-2020
Primary	Safety endpoints during index hospitalisation	Major vascular complications,	2018 - 2020
Primary	Safety endpoints during index hospitalisation ( bleeding)	life-threatining-, major bleeding	2018-2020
Primary	Safety endpoints during index hospitalisation ( death )	death	2018-2020
Secondary	efficacy endpoints during index hospitalisation - (hemotasis)	hemotasis in angiogram	2018-2020
Secondary	efficacy endpoints during index hospitalisation ( device failure)	device failure	2018-2020
Secondary	efficacy endpoints during index hospitalisation ( bail-out )	need for stent-graft	2018-2020