Manta™ Versus Suture-based Closure After Transcatheter Aortic Valve Implantation Trial (MASH-TAVI)

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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: MANTA vascular closure device; Device: Suture based vascular closure device

Detailed Description

see summary

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Rotterdam, Netherlands, 3000 CA
    • Erasmus University Medical Center Rotterdam

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MANTA vascular closure device; Arteriotomy closure with a collagen-based vascular closure device (MANTA™)	Device: MANTA vascular closure device; Collagen based vascular closure device
Active Comparator: Suture based vascular closure device; Arteriotomy closure with 2 or more suture-based vascular closure devices (ProGlide)	Device: Suture based vascular closure device; Suture based vascular closure device (ProGlide)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
Total procedure time	The total procedural time in minutes will be compared between the two treatment arms	During the TAVI procedure
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
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

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Investigators: Principal Investigator: Nicolas M van Mieghem, MD, PhD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2018
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: January 18, 2019
• First Posted (Actual): January 22, 2019

Study Record Updates

• Last Update Posted (Actual): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 24, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Vascular Closure Devices; Transcatheter Aortic Valve Implantation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: MASH TAVI 06-09-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: no sharing of individual data (no permission from participants. GDPR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes