Clinical trial NCT05662748: Comparison Between Manta and Prostar Closure Devices
Official title: Use of the Closure Device in Patient With Percutaneous Transfemoral Aortic Valve Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Keywords: Closure
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with planned treatment of aortic valve replacement will be asked to participate in the observational study

Brief summary: Use of the closure device in patient with percutaneous 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety endpoints during index hospitalisation
timeFrame: 2018 - 2020
measure: Safety endpoints during index hospitalisation ( bleeding)
timeFrame: 2018-2020
measure: Safety endpoints during index hospitalisation ( death )
timeFrame: 2018-2020
Secondary outcomes:
measure: efficacy endpoints during index hospitalisation - (hemotasis)
timeFrame: 2018-2020
measure: efficacy endpoints during index hospitalisation ( device failure)
timeFrame: 2018-2020
measure: efficacy endpoints during index hospitalisation ( bail-out )
timeFrame: 2018-2020
Other outcomes:
measure: preperation time
timeFrame: 2018-2020
Locations:
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
state: NRW
Study officials:
affiliation: Universitätsklinikum Aachen Medizinische Klinik 1
name: Jörg Schröder
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinikum Aachen Medizinische Klinik 1
name: Michael Lehrke
role: PRINCIPAL_INVESTIGATOR
References: