Recruiting

Left Atrial Appendage ClosureCanadian Left Atrial Appendage Closure Study

Sponsor:

Cardia Inc.

Code:

NCT03133806

Conditions

Left Atrial Appendage

Non-Valvular Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Ultrasept LAA Closure System

Study Details

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

Study ID

NCT03133806

Start date

Feb 15, 2017

Status verified date

Apr, 2017

Completion date

Aug 15, 2018

Anticipated

Primary completion date

Aug, 2018

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ultrasept LAA Closure System

Interventional percutaneous transcatheter device.

Interventions

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.

Primary outcome measure

Stroke, pericardial effusion, device embolization and device thrombosis [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Vice President of Operations

651-691-4100 cardia@cardia.com

Locations

Quebec Heart & Lung Institute Laval University

Recruiting

Quebec, Canada, G1V 4G5

Contacts

Emilie Pelletier Beaumont, M. Sc.

418-656-8711 emilie.pelletier-beaumont@criucpq.ulaval.ca

Principal Investigator:

Josep Rodés-Cabau

More Information

Sponsor

Cardia Inc.

Last update posted

Apr 28, 2017

Last verified

Apr, 2017

Keywords

Percutaneous Occlusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cardia Inc. on 2017-04-28.