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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-30

Study Completion Date

2020-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison Between Manta and Prostar Closure Devices

NCT05662748

Aortic Valve Stenosis

COMPLETED

Short-term Clinical Follow-up of the Vascular Closure Device MANTATM in Minimally Invasive Cardiac Surgery

NCT04802200

Femoral Artery Injury Aortic Valve Insufficiency

COMPLETED

Clinical Evaluation of MDT-2111 in Subjects With Symptomatic Severe Aortic Stenosis

NCT01437098

Aortic Valve Stenosis

COMPLETED NA

Clinical Evaluation of MDT-2111 in Subjects With Small Aortic Annuli and Symptomatic Severe Aortic Stenosis

NCT01634269

Aortic Valve Stenosis

COMPLETED NA

Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation.

NCT04009434

Aortic Stenosis Mitral Regurgitation

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

see summary

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aortic Valve Stenosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open label randomized trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MANTA vascular closure device

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

Group Type ACTIVE_COMPARATOR

MANTA vascular closure device

Intervention Type DEVICE

Collagen based vascular closure device

Suture based vascular closure device

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

Group Type ACTIVE_COMPARATOR

Suture based vascular closure device

Intervention Type DEVICE

Suture based vascular closure device (ProGlide)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MANTA vascular closure device

Collagen based vascular closure device

Intervention Type DEVICE

Suture based vascular closure device

Suture based vascular closure device (ProGlide)

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No