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

Primary Purpose

Aortic Valve Stenosis

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
MANTA vascular closure device
Suture based vascular closure device
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Vascular Closure Devices, Transcatheter Aortic Valve Implantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Erasmus University Medical Center Rotterdam

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

MANTA vascular closure device

Suture based vascular closure device

Arm Description

Arteriotomy closure with a collagen-based vascular closure device (MANTA™)

Arteriotomy closure with 2 or more suture-based vascular closure devices (ProGlide)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants with a Major Vascular Complication according to VARC-2
total number of participants major vascular complications
Number of Participants with a Minor Vascular Complication according to VARC-2
total number of participants minor vascular complications
All-cause death rate
A distinction between cardiac-, non-cardiac vascular and non-cardiovascular death will be made
Number of Participants with a major- or life threatening bleeding according to VARC-2
total number of participants with major/life-threatening bleedings
Need for transfusions for access site related bleeding/complications
Total number of transfusions of RBC because of site-related bleeding
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)
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
Total procedure time
The total procedural time in minutes will be compared between the two treatment arms
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
Length of hospital stay
The total length of hospital stay in days will be compared between the two treatment arms

Full Information

First Posted
January 17, 2019
Last Updated
March 24, 2021
Sponsor
Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03811119
Brief Title
Manta™ Versus Suture-based Closure After Transcatheter Aortic Valve Implantation Trial
Acronym
MASH-TAVI
Official Title
MANTA™ Versus Suture-based Closure After Transcatheter Aortic Valve Implantation Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 30, 2018 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
see summary

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis
Keywords
Vascular Closure Devices, Transcatheter Aortic Valve Implantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open label randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MANTA vascular closure device
Arm Type
Active Comparator
Arm Description
Arteriotomy closure with a collagen-based vascular closure device (MANTA™)
Arm Title
Suture based vascular closure device
Arm Type
Active Comparator
Arm Description
Arteriotomy closure with 2 or more suture-based vascular closure devices (ProGlide)
Intervention Type
Device
Intervention Name(s)
MANTA vascular closure device
Intervention Description
Collagen based vascular closure device
Intervention Type
Device
Intervention Name(s)
Suture based vascular closure device
Intervention Description
Suture based vascular closure device (ProGlide)
Primary Outcome Measure Information:
Title
Composite rate of major- and minor vascular complications according to VARC-2
Description
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.
Time Frame
Between transcatheter aortic valve implantation and 30 days follow-up
Secondary Outcome Measure Information:
Title
Number of Participants with a Major Vascular Complication according to VARC-2
Description
total number of participants major vascular complications
Time Frame
Between transcatheter aortic valve implantation and 30 days follow-up
Title
Number of Participants with a Minor Vascular Complication according to VARC-2
Description
total number of participants minor vascular complications
Time Frame
Between transcatheter aortic valve implantation and 30 days follow-up
Title
All-cause death rate
Description
A distinction between cardiac-, non-cardiac vascular and non-cardiovascular death will be made
Time Frame
Between transcatheter aortic valve implantation and 30 days follow-up
Title
Number of Participants with a major- or life threatening bleeding according to VARC-2
Description
total number of participants with major/life-threatening bleedings
Time Frame
Between transcatheter aortic valve implantation and 30 days follow-up
Title
Need for transfusions for access site related bleeding/complications
Description
Total number of transfusions of RBC because of site-related bleeding
Time Frame
Between transcatheter aortic valve implantation and 30 days follow-up
Title
Number of Participants with vascular closure device failure
Description
Failure of a closure device to achieve haemostasis at the arteriotomy site leading to alternative treatment (other than manual compression or adjunctive endovascular ballooning)
Time Frame
Between transcatheter aortic valve implantation and 30 days follow-up
Title
Time to hemostasis
Description
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
Time Frame
During the TAVI procedure
Title
Total procedure time
Description
The total procedural time in minutes will be compared between the two treatment arms
Time Frame
During the TAVI procedure
Title
Number of Participants with a clinically relevant bleeding defined as BARC 2, 3 and 5
Description
Clinically relevant bleeding defined as BARC 2, 3 and 5
Time Frame
Between transcatheter aortic valve implantation and 30 days follow-up
Title
Length of hospital stay
Description
The total length of hospital stay in days will be compared between the two treatment arms
Time Frame
Up to a maximum of 30 days after the TAVI procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas M Van Mieghem, MD, PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasmus University Medical Center Rotterdam
City
Rotterdam
ZIP/Postal Code
3000 CA
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no sharing of individual data (no permission from participants. GDPR)

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

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