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

Not Applicable

Completed

• Conditions: Aortic Valve Stenosis
• Interventions: Device: MANTA vascular closure device; Device: Suture based vascular closure device

• Registration Number: NCT03811119
• Lead Sponsor: Erasmus Medical Center

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

Study Timeline

• Study Start: 2018-10-30
• Study First Submitted: 2019-01-17
• Study First Submitted QC: 2019-01-18
• Study First Posted: 2019-01-22
• Primary Completion: 2020-02-01
• Study Completion: 2020-04-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-24
• Last Update Posted: 2021-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MANTA vascular closure device	MANTA vascular closure device	Arteriotomy closure with a collagen-based vascular closure device (MANTA™)
Suture based vascular closure device	Suture based vascular closure device	Arteriotomy closure with 2 or more suture-based vascular closure devices (ProGlide)

Primary Outcome Measures

Name	Time	Method
Composite rate of major- and minor vascular complications according to VARC-2	Between transcatheter aortic valve implantation and 30 days follow-up	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

Name	Time	Method
Number of Participants with a Major Vascular Complication according to VARC-2	Between transcatheter aortic valve implantation and 30 days follow-up	total number of participants major vascular complications
Number of Participants with a Minor Vascular Complication according to VARC-2	Between transcatheter aortic valve implantation and 30 days follow-up	total number of participants minor vascular complications
Time to hemostasis	During the TAVI procedure	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
Length of hospital stay	Up to a maximum of 30 days after the TAVI procedure	The total length of hospital stay in days will be compared between the two treatment arms
All-cause death rate	Between transcatheter aortic valve implantation and 30 days follow-up	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	Between transcatheter aortic valve implantation and 30 days follow-up	total number of participants with major/life-threatening bleedings
Need for transfusions for access site related bleeding/complications	Between transcatheter aortic valve implantation and 30 days follow-up	Total number of transfusions of RBC because of site-related bleeding
Number of Participants with vascular closure device failure	Between transcatheter aortic valve implantation and 30 days follow-up	Failure of a closure device to achieve haemostasis at the arteriotomy site leading to alternative treatment (other than manual compression or adjunctive endovascular ballooning)
Total procedure time	During the TAVI procedure	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	Between transcatheter aortic valve implantation and 30 days follow-up	Clinically relevant bleeding defined as BARC 2, 3 and 5

Trial Locations

Locations (1)

Erasmus University Medical Center Rotterdam; 🇳🇱 Rotterdam, Netherlands