RecruitingACTRN12610000921088

Coherex WaveCrest Left Atrial Appendage Occlusion Study A multi-center study to evaluate the safety and efficacy of the Coherex WaveCrest Left Atrial Appendage Occlusion System

A Feasibility study of 200 patients with non-valvular atrial fibrillation and an ongoing indication for anticoagulation to prevent embolic stroke that will have left atrial appendage closure with the Coherex Left Atril Appendage Occlusion System to evaluate the safety and efficacy of the device in preventing embolic stroke.


Sponsor

Coherex Medical Inc.

Enrollment

200 participants

Start Date

Oct 20, 2010

Study Type

Interventional

Conditions

Summary

The primary study objective is to verify that under normal conditions of use the Coherex Left Atrial Appendage Occlusion System is a safe and effective LAA occlusion device. This investigation will be accomplished by: 1) implanting the device in patients with non-valvular paroxysmal, persistent, or permanent atrial fibrillation when anticoagulation is indicated for potential thrombus formation in the left atrium; 2) assessing LAA occlusion; and 3) monitoring adverse events at 45 days and/or up to one year post procedure. The study will also be designed to demonstrate the safety of the Coherex Left Atrial Appendage Occlusion System by assessing: 1) ease of successful device insertion; 2) positioning accuracy; 3) placement stability; and 4) post-procedure adverse events. To achieve this objective, data will be collected before, during, and after the procedure.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a device called the Coherex WaveCrest that is designed to plug (occlude) a small pouch in the heart called the left atrial appendage. In people with atrial fibrillation (an irregular heartbeat), blood clots can form in this pouch and cause strokes. The device is an alternative to blood-thinning medications for people who cannot take them safely. Researchers will check that the device is safe and effective at sealing the appendage. You may be eligible if: - You are 18 years of age or older - You have been diagnosed with non-valvular atrial fibrillation (paroxysmal, persistent, or permanent) - You need long-term blood thinning treatment, OR you cannot safely take blood thinners - You do not have another condition that requires long-term blood thinners - Your CHADS stroke risk score equals 1 - You are willing to attend all required follow-up visits You may NOT be eligible if: - You have had a stroke or TIA (mini-stroke) in the past 30 days - You had a heart attack in the past 3 months - You have severe heart failure (Class IV) - You have a blood clot or cardiac tumor in the heart - You have a mechanical heart valve or have had a heart transplant - You are pregnant or planning to become pregnant - Your resting heart rate is above 110 beats per minute Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

The Coherex Left Atrial Appendage Occlusion System is a permanent implant to close the orifice of the left atrial appendage and will be placed during a one hour percutaneous transcatheter intervention

The Coherex Left Atrial Appendage Occlusion System is a permanent implant to close the orifice of the left atrial appendage and will be placed during a one hour percutaneous transcatheter intervention. Post procedurte patients will be monitored for adverse events and in particular the occurance of thrombolic events originating from the left heart for a minimum of one year.


Locations(4)

Frankfurt, Germany

Copenhagen, Denmark

Auckland, New Zealand

Meercogliano, Italy

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12610000921088