Canadian Left Atrial Appendage Closure Study

NCT03133806 | Unknown

• 1 other identifier: CLIN-2026
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Left Atrial Appendage; Non-Valvular Atrial Fibrillation

Keywords

Percutaneous Occlusion

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (1)

Ultrasept LAA Closure System

EXPERIMENTAL

Interventional percutaneous transcatheter device.

Device: Ultrasept LAA Closure System

Interventions

Ultrasept LAA Closure System DEVICE

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.

Also known as: Ultrasept, Ultrasept LAA Closure Device

Ultrasept LAA Closure System

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Cardia Inc.: lead

Study Sites (1)

Quebec Heart & Lung Institute Laval University

Québec, G1V 4G5, Canada

RECRUITING

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vice President of Operations

CONTACT

651-691-4100; cardia@cardia.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a multicenter, prospective, single arm design.

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 28, 2017
• Study Start: February 15, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 15, 2018
• Last Updated: April 28, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)