Manta™ Versus Suture-based Closure After Transcatheter Aortic Valve Implantation Trial

Aortic Valve Stenosis Clinical Trial

— MASH-TAVI  

Official title:

MANTA™ Versus Suture-based Closure After Transcatheter Aortic Valve Implantation Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03811119
• Other study ID #: MASH TAVI 06-09-2018
• Status: Completed
• Phase: N/A
• Start date: October 30, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: March 2021
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate whether the collagen-based MANTA vascular closure device (VCD) is superior to suture-based VCDs in preventing vascular access site complications in patients undergoing transfemoral transcatheter aortic valve replacement.

Description:

see summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: April 30, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing elective transfemoral TAVI for severe aortic valve stenosis with any commercially-available transcatheter heart valve (THV)

• Common femoral artery diameter > 5.0mm (14 - 22F compatible)

Exclusion Criteria:

• Symptomatic leg ischaemia

• Previous thromboendarterectomy or plastic patch of the common femoral artery

• Previous implantation of a suture-based VCD less than 30 days before, or a plug-based VCD within 6 months

• Unilateral or bilateral lower extremity amputation

• Systemic infection or a local infection at or near the access site

• Allergy to the components any of both devices (i.e. bovine materials or any other device material, including collagen and/or collagen products, polyglycolic or polylactic acid, stainless steel or nickel)

• Active bleeding or bleeding diathesis including thrombocytopenia (platelet count <50,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease

• Patients in whom continuous oral anticoagulation therapy cannot be stopped for the peri-procedural period or patients with INR >1.8 at the time of the procedure

• Patient unable to be adequately anti-coagulated for the procedure

• Morbidly obese or cachectic (BMI >40 kg/m2 or <20 kg/m2)

• Anatomical and procedural contraindication for suture-based or Manta closure (lack of proper puncture site in the common femoral artery in terms of calcification, size, and atherosclerotic disease)

• Absence of computed tomographic data of the access site before the procedure

• Patient cannot adhere to or complete the investigational protocol for any reason including but not limited to geographical residence, psychiatric condition or life threatening disease

• Known pregnancy at time of randomization (in women of childbearing potential a negative pregnancy test is mandatory)

• Participating in trials in which the primary endpoint includes bleeding or vascular complications

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• MANTA vascular closure device
Collagen based vascular closure device
• Suture based vascular closure device
Suture based vascular closure device (ProGlide)

Locations

Country	Name	City	State
Netherlands	Erasmus University Medical Center Rotterdam	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite rate of major- and minor vascular complications according to VARC-2	The primary endpoint will consist of the composite of major- and minor vascular complications according to the Valve Academic Research Consortium (VARC)-2 at 30 days follow-up.	Between transcatheter aortic valve implantation and 30 days follow-up
Secondary	Number of Participants with a Major Vascular Complication according to VARC-2	total number of participants major vascular complications	Between transcatheter aortic valve implantation and 30 days follow-up
Secondary	Number of Participants with a Minor Vascular Complication according to VARC-2	total number of participants minor vascular complications	Between transcatheter aortic valve implantation and 30 days follow-up
Secondary	All-cause death rate	A distinction between cardiac-, non-cardiac vascular and non-cardiovascular death will be made	Between transcatheter aortic valve implantation and 30 days follow-up
Secondary	Number of Participants with a major- or life threatening bleeding according to VARC-2	total number of participants with major/life-threatening bleedings	Between transcatheter aortic valve implantation and 30 days follow-up
Secondary	Need for transfusions for access site related bleeding/complications	Total number of transfusions of RBC because of site-related bleeding	Between transcatheter aortic valve implantation and 30 days follow-up
Secondary	Number of Participants with vascular closure device failure	Failure of a closure device to achieve haemostasis at the arteriotomy site leading to alternative treatment (other than manual compression or adjunctive endovascular ballooning)	Between transcatheter aortic valve implantation and 30 days follow-up
Secondary	Time to hemostasis	After the use of a vascular closure device the time to hemostasis will be classified as immediate hemostasis, hemostasis after 5 minutes manual compression, hemostasis after 10 minutes manual compression, hemostasis after endovascular ballooning, hemostasis after endovascular intervention or hemostasis after surgical intervention	During the TAVI procedure
Secondary	Total procedure time	The total procedural time in minutes will be compared between the two treatment arms	During the TAVI procedure
Secondary	Number of Participants with a clinically relevant bleeding defined as BARC 2, 3 and 5	Clinically relevant bleeding defined as BARC 2, 3 and 5	Between transcatheter aortic valve implantation and 30 days follow-up
Secondary	Length of hospital stay	The total length of hospital stay in days will be compared between the two treatment arms	Up to a maximum of 30 days after the TAVI procedure