Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation (CHOICE-CLOSURE)

September 28, 2021 updated by: Leipzig Heart Institute GmbH
The aim of the study is to evaluate the clinical efficacy of 2 different vascular closure device (VCD) strategies during transfemoral transcatheter aortic valve implantation (TAVI). The study hypothesizes that the choice of one over the other VCD in patients undergoing transfemoral TAVI may demonstrate relevant differences in the rate of peri-procedural complications and effectiveness of vascular closure.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Use of a plug-based VCD in patients undergoing transfemoral TAVI as compared to a suture-based VCD.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
516

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany
        • Herzzentrum Leipzig

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with an indication for transfemoral TAVI as judged by the local heart team.
  2. Transfemoral access route and a commercially-available transcatheter aortic valve is selected by the local heart team.
  3. The patient is willing to provide written informed consent and comply with protocol- specified follow-up evaluations.

Exclusion Criteria:

  1. Vascular access site anatomy not suitable for percutaneous vascular closure.
  2. Vascular access site complications prior to the TAVI procedure.
  3. Known allergy or hypersensitivity to any VCD component.
  4. Unstable active bleeding/ bleeding diathesis or significant unmanageable anemia.
  5. Absence of computed tomographic data of the access site before the procedure.
  6. Systemic infection or a local infection at or near the access site.
  7. Life expectancy of less than 6 months due to non-cardiac conditions.
  8. Patient cannot adhere to or complete the investigational protocol for any reason.
  9. Pregnant or nursing subjects.
  10. Participation in any other interventional trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Manta
plug-based vascular closure
Device: Manta
plug-based vascular closure
Active Comparator: ProGlide
suture-based vascular closure
Device: ProGlide
suture-based vascular closure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition
Time Frame: up to 7 days
Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition
up to 7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of access-site or access-related vascular injury
Time Frame: 30 days
Rate of access-site or access-related vascular injury
30 days
Rate of major access-site or access-related vascular injury
Time Frame: up to 7 days and at 30 days
Rate of major access-site or access-related vascular injury
up to 7 days and at 30 days
Rate of minor access site or access-related vascular injury
Time Frame: up to 7 days and at 30 days
Rate of minor access site or access-related vascular injury
up to 7 days and at 30 days
Rate of access-site or access-related vascular injury, access-site or access-related bleeding and VCD failure according to VARC-2 criteria
Time Frame: up to 7 days and at 30 days)
Rate of access-site or access-related vascular injury, access-site or access-related bleeding and VCD failure according to VARC-2 criteria
up to 7 days and at 30 days)
all-cause death
Time Frame: up to 7 days and 30-day
all-cause death
up to 7 days and 30-day
death attributed to access-site or access-related complications
Time Frame: up to 7 days and 30-day
death attributed to access-site or access-related complications
up to 7 days and 30-day
Unplanned vascular surgery and / or use of endovascular stent or stent-graft or other endovascular interventions at the puncture site
Time Frame: up to 7 days
Unplanned vascular surgery and / or use of endovascular stent or stent-graft or other
up to 7 days
access-site or access-related disabling/life- threatening bleeding according to BARC
Time Frame: up to 7 days and 30-day
access-site or access-related disabling/life- threatening bleeding according to BARC
up to 7 days and 30-day
access-site or access-related major bleeding according to BARC
Time Frame: up to 7 days and 30-day
access-site or access-related major bleeding according to BARC
up to 7 days and 30-day
access-site or access-related minor bleeding according to BARC
Time Frame: up to 7 days and 30-day
access-site or access-related minor bleeding according to BARC
up to 7 days and 30-day
Need for blood transfusion for access-site or access-related bleeding or vascular complications
Time Frame: up to 7 days
Need for blood transfusion for access-site or access-related bleeding or vascular complications
up to 7 days
Total number of blood transfusions because of access-site or access-related bleeding
Time Frame: up to 7 days
Total number of blood transfusions because of access-site or access-related bleeding
up to 7 days
Rate of vascular closure device success, defined as the ability of a closure device strategy to obtain hemostasis
Time Frame: 24 hours
Rate of vascular closure device success, defined as the ability of a closure device strategy to obtain hemostasis
24 hours
Rate of vascular closure device failure, defined as failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment
Time Frame: 24 hours
Rate of vascular closure device failure, defined as failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment
24 hours
Length of postprocedural hospital stay
Time Frame: up to 7 days
Length of postprocedural hospital stay
up to 7 days
Time to hemostasis, defined as the time from VCD application to complete hemostasis
Time Frame: 24 hours
Time to hemostasis, defined as the time from VCD application to complete hemostasis
24 hours
Need and number of additional unplanned VCDs
Time Frame: 24 hours
Need and number of additional unplanned VCDs
24 hours
Percent diameter stenosis of vascular access vessel on post-procedural angiography
Time Frame: 24 hours
Percent diameter stenosis of vascular access vessel on post-procedural angiography
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Leipzig Heart Institute GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mohamed Abdel-Wahab, PD Dr., Herzzentrum Leipzig GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 26, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 7, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 4, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-0191

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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