Canadian Left Atrial Appendage Closure Study (CLASS)

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: Unknown
• Conditions: Non-Valvular Atrial Fibrillation; Left Atrial Appendage
• Intervention / Treatment: Device: Ultrasept LAA Closure System

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: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: 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: Emilie Pelletier Beaumont, M. Sc.; Phone Number: 3929 418-656-8711; Email: emilie.pelletier-beaumont@criucpq.ulaval.ca
    • Principal Investigator: Josep Rodes-Cabau

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Stroke, pericardial effusion, device embolization and device thrombosis	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	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

• Sponsor: Cardia Inc.
• Investigators: 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

Study Major Dates

• Study Start (Actual): February 15, 2017
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): August 15, 2018

Study Registration Dates

• First Submitted: April 17, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (Actual): April 28, 2017

Study Record Updates

• Last Update Posted (Actual): April 28, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Percutaneous Occlusion
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID 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