Left Atrial AppendageCLASSNCT03133806
Canadian Left Atrial Appendage Closure Study
A study testing Ultrasept LAA Closure System in people with Left Atrial Appendage and Non-Valvular Atrial Fibrillation, run by Cardia Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Left Atrial Appendage, Non-Valvular Atrial Fibrillation
- What is being tested?
- Ultrasept LAA Closure System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 15 Feb 2017to 15 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Quebec Heart & Lung Institute Laval University
Québec, G1V 4G5
Emilie Pelletier Beaumont, M. Sc., 418-656-8711 ext. 3929, emilie.pelletier-beaumont@criucpq.ulaval.ca
Josep Rodés-Cabau
About this study
Official title: 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.
Read the 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.
- Being tested
- Ultrasept LAA Closure System
- Keywords
- Percutaneous Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasept LAA Closure SystemDevice
Also called Ultrasept, Ultrasept LAA Closure 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.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasept LAA Closure System | Experimental | Interventional percutaneous transcatheter device. Receives: Device: Ultrasept LAA Closure System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: This endpoint will be evaluated at 45 days post-implant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start15 Feb 2017
- Primary completionAug 2018 (estimated)
- Study completion15 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Atrial AppendageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is a multicenter, prospective, single arm design.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardia Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Reda Ibrahim, MD, Principal investigator, Montreal Heart InstituteJean-Bernard Masson, MD FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)Josep Rodés-Cabau, MD, Principal investigator, Quebec Heart & Lung Institute Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133806
- Sponsor's protocol ID
- CLIN-2026
- Acronym
- CLASS
- Status last verified
- Apr 2017
- First submitted
- 17 Apr 2017
- Last updated
- 28 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLASS Canadian Left Atrial Appendage Closure Study
- ClinicalTrials.gov ID
- NCT03133806
- Acronym / sponsor ID
- CLASS / CLIN-2026
- Keywords
- Percutaneous Occlusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cardia Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- 15 Aug 2018 (estimated)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is a multicenter, prospective, single arm design.
| Arm | Type | Receives |
|---|---|---|
| Ultrasept LAA Closure System | Experimental | Device: Ultrasept LAA Closure SystemInterventional percutaneous transcatheter device. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasept LAA Closure SystemAlso: Ultrasept, Ultrasept LAA Closure DeviceThe 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. | Device | Ultrasept LAA Closure System |
Primary outcome
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.
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reda Ibrahim, MD principal investigator
Montreal Heart Institute
Jean-Bernard Masson, MD FRCPC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
Josep Rodés-Cabau, MD principal investigator
Quebec Heart & Lung Institute Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasept LAA Closure System in people with Left Atrial Appendage and Non-Valvular Atrial Fibrillation, run by Cardia Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vice President of Operations (651-691-4100, cardia@cardia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke, pericardial effusion, device embolization and device thrombosis (time frame: This endpoint will be evaluated at 45 days post-implant.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2017.