- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02239887
Coherex WAVECREST I Left Atrial Appendage Occlusion Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary Safety Endpoint The primary safety endpoint is the incidence of major adverse events up to 45 days post-procedure. Major adverse events are defined as life-threatening incidents as determined by the Clinical Events Committee (CEC) and include events such as device embolization; cardiac injury, re-intervention, and/or device-related surgery; bleeding events such as pericardial effusion requiring drainage, cranial bleeding due to any source, gastrointestinal bleeding; or any other event related to the device or the procedure, which requires treatment.
Primary Efficacy Endpoint The primary efficacy endpoint is the incidence of LAA occlusion at 45 and/or 180 days (+ten days) post-procedure. LAA occlusion will be assessed by transesophageal echocardiography (TEE) color flow Doppler and will be defined as absence of flow in the LAA or color flow Doppler jets less than 3mm.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:Candidates for this study must meet ALL of the following criteria
- At least 18 years of age.
- Diagnosis of paroxysmal, persistent, or permanent non-valvular atrial fibrillation.
- Indicated for long-term anticoagulation therapy including patients on anticoagulants and patients with a contraindication to anticoagulation. The first 30 patients must have a contraindication to anticoagulation.
- Eligible for cessation of anticoagulation therapy if the LAA is sealed (i.e., the patient has no other condition requiring anticoagulation therapy).
- Calculated CHADS score ≥ 1.
- Willingness to participate in the required follow-up visits and tests.
- Willingness of patient or legal representative to provide written informed consent.
- Female subjects of child-bearing potential must have a negative serum pregnancy test within 7 days prior to the index procedure, and must be willing to use reliable contraception methods for one year post-procedure.
Exclusion Criteria:
- Known contraindication and/or allergy to aspirin, clopidogrel, IV contrast, or nickel.
- Extensive congenital cardiac anomalies, which can only be adequately repaired by cardiac surgery.
- Stroke or transient ischemic attack (TIA), as diagnosed by a neurologist, within the past 30 days. Patients with a history of stroke or TIA will not be allowed to enroll until 30 days post stroke or TIA have been completed.
- New York Heart Association Class IV Congestive Heart Failure, defined as patients with severe physical limitations and symptoms even while at rest.
- Myocardial infarction within the past three months.
- Sepsis within one month prior to implantation or any systemic infection that cannot be successfully treated prior to device placement.
- Presence of an atrial septal defect, atrial septal repair, or atrial septal closure device.
- Female subjects who may be pregnant or are planning on becoming pregnant in the next year.
- Cardioversion or ablation procedure planned in conjunction with or within 30 days after placement of the Coherex WaveCrest Left Atrial Appendage Occlusion System.
- Cardiac transplant or mechanical valve.
- Symptomatic carotid artery disease.
- Any medical disorder or psychiatric illness that would interfere with successful completion of the study as determined by the investigator.
- Conditions other than atrial fibrillation requiring long-term warfarin therapy.
- Resting heart rate > 110 beats per minute (bpm).
- A single episode of transient atrial fibrillation.
- Thrombocytopenia (<50,000 platelets/mm3), thrombocythemia (>700,000 platelets/mm³), leucopenia (white blood cell count < 3,000 cells/mm³), or anemia (hemoglobin concentration < 10 gram per deciliter [g/dl]).
- Currently participating in an investigational drug or another device trial that has not completed the primary endpoint or that clinically interferes with the current trial endpoints. (Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.)
- Any condition that would reduce life expectancy to less than two years from the date of the index procedure.
Echocardiographic criteria for exclusion:
- Left ventricular ejection fraction (LVEF) < 30%.
- Mitral valve stenosis < 1.5 cm2 or any stenosis consistent with rheumatic valvular disease.
- Pericardial effusion > 5 mm pre-procedure.
- Evidence of intracardiac thrombus visualized on TEE.
- Presence of a patent foramen ovale (PFO) that demonstrates a large shunt and/or atrial septal aneurysm with > 10 mm excursion.
- Cardiac tumor.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
WaveCrest LAA occlusion device
Left Atrial Occlusion
|
Left Atrial Appendage Occlusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Safety Endpoint
Time Frame: 45 Days post procedure
|
The primary safety endpoint is the incidence of major adverse events up to 45 days post-procedure.
Major adverse events are defined as life-threatening incidents as determined by the Clinical Events Committee (CEC) and include events such as device embolization; cardiac injury, re-intervention, and/or device-related surgery; bleeding events such as pericardial effusion requiring drainage, cranial bleeding due to any source, gastrointestinal bleeding; or any other event related to the device or the procedure, which requires treatment.
|
45 Days post procedure
|
Primary Efficacy Endpoint
Time Frame: 45 and/or 180 days post procedure
|
The primary efficacy endpoint is the incidence of LAA occlusion at 45 and/or 180 days (+ten days) post-procedure.
LAA occlusion will be assessed by transesophageal echocardiography (TEE) color flow Doppler and will be defined as absence of flow in the LAA or color flow Doppler jets less than 3mm.
|
45 and/or 180 days post procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary Safety Endpoint
Time Frame: 180 days and one year post-procedure
|
The secondary safety endpoint is the incidence of serious adverse events at 180 days and one year post-procedure.
Serious adverse events are defined as any events that result in death, are life-threatening, require in-patient hospitalization or prolongation of existing hospitalization, or result in permanent or significant disability/incapacity.
|
180 days and one year post-procedure
|
Secondary Efficacy Endpoints
Time Frame: intra operative
|
|
intra operative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IP005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non-valvular Paroxysmal, Persistent, or Permanent Atrial Fibrillation
-
Prof. Dr. med. Ingo EitelRecruitingNon-valvular Atrial Fibrillation (NVAF): Paroxysmal, Persistent, PermanentGermany
-
AstraZenecaCompletedPersistent or Permanent Non-valvular Atrial FibrillationSweden, Poland, Russian Federation, United Kingdom, Norway, Denmark
-
Maastricht University Medical CenterNot yet recruitingAtrial Fibrillation | Pacemaker DDD | Paroxysmal Atrial Fibrillation | Persistent Atrial Fibrillation | Permanent Atrial Fibrillation
-
Ablacon, Inc.RecruitingAtrial Fibrillation | Arrhythmias, Cardiac | Arrhythmia | Atrial Flutter | Atrial Fibrillation, Persistent | Atrial Tachycardia | Atrial Arrhythmia | Atrial Fibrillation Paroxysmal | Atrial Fibrillation, Paroxysmal or PersistentUnited States, Belgium, Netherlands, Czechia
-
AstraZenecaCompletedPersistent or Permanent Nonvalvular Atrial Fibrillation
-
Vivek ReddyEnrolling by invitationAtrial Fibrillation and Flutter | Atrial Flutter Typical | Atrial Fibrillation, Paroxysmal or PersistentUnited States
-
Ratika ParkashNova Scotia Health Research FundNot yet recruitingAtrial Fibrillation, Paroxysmal or Persistent
-
University Hospital OstravaRecruiting
-
Beijing Anzhen HospitalJohnson & Johnson; Heart Health Research CenterNot yet recruitingParoxysmal Atrial Fibrillation | Persistent Atrial Fibrillation
-
Maastricht UniversityRadboud University Medical Center; Maastricht University Medical CenterRecruitingAtrial Fibrillation | Atrial Fibrillation, Persistent | Atrial Fibrillation ParoxysmalNetherlands
Clinical Trials on WaveCrest LAA occlusion device
-
Coherex MedicalBiosense Webster, Inc.TerminatedStrokeUnited States, Australia
-
Medtronic CardiovascularTerminatedLeft Atrial Appendage OcclusionUnited States
-
Boston Scientific CorporationWithdrawn
-
AuriGen Medical LtdRecruiting
-
Royal Brompton & Harefield NHS Foundation TrustUnknownPersistent Atrial FibrillationUnited Kingdom
-
Cardia Inc.UnknownNon-Valvular Atrial Fibrillation | Left Atrial AppendageCanada
-
Occlutech International ABCompleted
-
Abbott Medical DevicesRecruitingStroke | Atrial Fibrillation | BleedingUnited States, Australia, Netherlands, Denmark, Spain, Poland, France, Hong Kong, Switzerland, Germany, Japan, Czechia, Canada, Italy, United Kingdom, Lithuania
-
William A. Faubion, M.D.Recruiting