Canadian Left Atrial Appendage Closure Study (CLASS)

April 25, 2017 updated by: Cardia Inc.

CLASS Canadian Left Atrial Appendage Closure Study

The purpose of the study is to demonstrate the safety and the rate of closure of the Ultrasept Left Atrial Appendage (LAA) Closure System for the percutaneous occlusion of the left atrial appendage in patients with non-valvular atrial fibrillation.

Study Overview

Status

Status

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

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

The CLASS study is a multicenter, prospective, single arm trial designed to demonstrate the feasibility and short term efficacy of the Ultrasept Left Atrial Appendage Closure Device. Patients who present or are referred for participation in the study will be evaluated against the inclusion and exclusion criteria. Those meeting the criteria will be given the opportunity to participate. All patients will have protocol-required evaluations at each scheduled follow-up.

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 (Anticipated)

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.
30

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Vice President of Operations
  • Phone Number: 651-691-4100
  • Email: cardia@cardia.com

Study Locations

  • Canada
      • Quebec, Canada, G1V 4G5
        • Recruiting
        • Quebec Heart & Lung Institute Laval University
        • Contact:
        • Principal Investigator:
          • Josep Rodes-Cabau

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject has a documented history of paroxysmal, persistent or permanent non-valvular atrial fibrillation.
  • Subject is able to provide informed consent for the procedure.
  • Subject is able to be followed for the duration of the study.
  • Patient is able to take aspirin and Clopidogrel. Expected duration of dual antiplatelet therapy of 45 days.
  • Patient is not able to tolerate or adhere to the requirements of long term anticoagulation therapy.
  • Subject has a CHADS score >/= 1.

Exclusion Criteria:

  • The patient is known to have an extensive congenital cardiac anomaly which can only be adequately repaired by way of cardiac surgery.
  • The patient's size (i.e., too small for TEE probe, catheter size, etc.) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization.
  • LAA anatomical exclusion (depth <16mm and/or diameter <11mm).
  • Patients with recent myocardial infarction, unstable angina, or decompensated congestive heart failure. (Recent is defined as within 180 days of implant date).
  • Patients with any type of serious infection less than one month prior to procedure.
  • Patient has demonstrated intracardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi).
  • Patient is participating in another investigational drug or device study.
  • Subject has an implanted atrial septal defect (ASD) device or patent foramen ovale (PFO) device.
  • Subject had surgical ASD or PFO repair.
  • Subject has a moderate to severe aortic or mitral valve stenosis or regurgitation as assessed by the investigator.
  • Subject has a planned ablation procedure for atrial fibrillation within 60 days after the Ultrasept LAA closure device implant.
  • Subject has a New York Heart Association (NYHA) grade 4.
  • Patient has a left ventricular ejection fraction of 20% or less.
  • Patient has a life expectancy of less than one year.
  • Subject has had a recent major cardiac surgical procedure (recent is defined as within 180 days of implant date).
  • Subject is pregnant, breastfeeding, or desires to become pregnant during their first 180 days post-implant.
  • Subject has a medical disorder that would interfere with completion or evaluation of clinical study results (for e.g. uncontrolled hypertension, uncontrolled diabetes, renal failure, in situ inferior vena cava filter).
  • Patient has an allergy to Nickel.

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: N/A
  • Interventional Model: Single Group 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.
Experimental: Ultrasept LAA Closure System
Interventional percutaneous transcatheter device.
Device: Ultrasept LAA Closure System
The Ultrasept Left Atrial Appendage Closure System Device is a percutaneous transcatheter device intended to prevent thrombus embolization from the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation.
Other Names:
  • Ultrasept, Ultrasept LAA Closure Device

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
Stroke, pericardial effusion, device embolization and device thrombosis
Time Frame: This endpoint will be evaluated at 45 days post-implant.
The safety endpoints are serious device or procedure-related Adverse Events (SAE) experienced with the Ultrasept Left Atrial Appendage Closure System such as stroke, pericardial effusion requiring treatment, device embolization and device thrombosis.
This endpoint will be evaluated at 45 days post-implant.
Peri-device leak rate
Time Frame: This endpoint will be evaluated at 45 days post-implant.
The efficacy endpoint is completed LAA closure (residual leak < 3 mm) as demonstrated by transesophageal echocardiogram (TEE).
This endpoint will be evaluated at 45 days post-implant.

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.
Cardia Inc.

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: Reda Ibrahim, MD, Montreal Heart Institute
  • Principal Investigator: Jean-Bernard Masson, MD FRCPC, Centre hospitalier de l'Université de Montréal (CHUM)
  • Principal Investigator: Josep Rodés-Cabau, MD, Quebec Heart & Lung Institute Laval University

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.
February 15, 2017

Primary Completion (Anticipated)

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.
August 1, 2018

Study Completion (Anticipated)

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 15, 2018

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).
April 17, 2017

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.
April 25, 2017

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.
April 28, 2017

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.
April 28, 2017

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.
April 25, 2017

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.
April 1, 2017

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.
  • CLIN-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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