Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000921088
Ethics application status
Approved
Date submitted
21/10/2010
Date registered
29/10/2010
Date last updated
29/10/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
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
Scientific title
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.
Secondary ID [1] 252425 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-valvular atrial fibrillation in anticoagulation indicated and contraindicated patient and the effect of implantation of a left atrial appendage closure system. 257932 0
Condition category
Condition code
Cardiovascular 258102 258102 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 256987 0
Treatment: Devices
Comparator / control treatment
There is no comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258963 0
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:
1. device embolization-assessed by imaging studies;
2. cardiac injury-assessed by clinical history and/or imaging studies;
3. re-intervention, and/or device-related surgery- need based on clinical assessment;
4. 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-assessed by clinical assessment, laboratory and imaging studies.
Timepoint [1] 258963 0
45 days
Primary outcome [2] 258964 0
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. The endpoint will be specified as closure at 180 days unless all of the patients are noted to be closed at the 45 day timepoint.
Timepoint [2] 258964 0
180 days and/or 45 days
Secondary outcome [1] 265144 0
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. All of these safety events are determined by a clinical assessment and assessed further, if necessary, by imaging and laboratory assessment.
Timepoint [1] 265144 0
180 days and one year
Secondary outcome [2] 265145 0
The secondary efficacy endpoints are:
1. Procedural success, defined as successful delivery, deployment, and release of the Coherex Left Atrial Appendage Occlusion System into the LAA, and includes successful recapture and retrieval, if necessary.
2. The incidence of LAA occlusion as measured by echocardiographic color flow Doppler jets less than 3mm by TEE at the end of the procedure.
Timepoint [2] 265145 0
The end of the interventional procedure.

Eligibility
Key inclusion criteria
1. At least 18 years of age.
2. Diagnosis of paroxysmal, persistent, or permanent non-valvular atrial fibrillation.
3. 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.
4. Eligible for cessation of anticoagulation therapy if the LAA is sealed (i.e., the patient has no other condition requiring anticoagulation therapy).
5. Calculated CHADS score = 1.
6. Willingness to participate in the required follow-up visits and tests.
7. Willingness of patient or legal representative to provide written informed consent.
8. 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known contraindication and/or allergy to aspirin, clopidogrel, IV contrast, or nickel.
2. Extensive congenital cardiac anomalies, which can only be adequately repaired by cardiac surgery.
3. 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 cases have been completed.
4. New York Heart Association Class IV Congestive Heart Failure, defined as patients with severe physical limitations and symptoms even while at rest.
5. Myocardial infarction within the past three months.
6. Sepsis within one month prior to implantation or any systemic infection that cannot be successfully treated prior to device placement.
7. Presence of an atrial septal defect, atrial septal repair, or atrial septal closure device.
8. Female subjects who may be pregnant or are planning on becoming pregnant in the next year.
9. Cardioversion or ablation procedure planned in conjunction with or within 30 days after placement of the Coherex Left Atrial Appendage Occlusion System.
10. Cardiac transplant or mechanical valve.
11. Symptomatic carotid artery disease.
12. Any medical disorder or psychiatric illness that would interfere with successful completion of the study as determined by the investigator.
13. Conditions other than atrial fibrillation requiring long-term warfarin therapy.
14. Resting heart rate > 110 beats per minute (bpm).
15. A single episode of transient atrial fibrillation.
16. 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]).
17. 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.)
18. Any condition that would reduce life expectancy to less than two years from the date of the index procedure.

Echocardiographic criteria for exclusion:
1. Left ventricular ejection fraction (LVEF) < 30%.
2. Mitral valve stenosis < 1.5 cm2 or any stenosis consistent with rheumatic valvular disease.
3. Pericardial effusion > 5 mm pre-procedure.
4. Evidence of intracardiac thrombus visualized on TEE.
5. Presence of a patent foramen ovale (PFO) that demonstrates a large shunt and/or atrial septal aneurysm with > 10 mm excursion.
6. Cardiac tumor.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All candidates for LAA closure by percutaneous methods should be screened for study eligibility. A member of the research team should consult the patient’s private physician for permission to approach the patient. If the physician agrees, a member of the research team should inform the patient about the study’s purpose and should obtain written informed consent. Patients who meet the clinical inclusion/exclusion criteria will be evaluated by TEE to determine if all echocardiographic inclusion/exclusion criteria are met. Screening will not be considered complete until a patient has been determined to have an LAA with appropriate anatomy and size for placement of the Coherex Left Atrial Appendage Occlusion System.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3135 0
Sydney, Melborne, Adelaide, Perth, Brisbane
Recruitment outside Australia
Country [1] 2813 0
Germany
State/province [1] 2813 0
Frankfurt
Country [2] 2814 0
Denmark
State/province [2] 2814 0
Copenhagen
Country [3] 2815 0
New Zealand
State/province [3] 2815 0
Auckland
Country [4] 2816 0
Italy
State/province [4] 2816 0
Meercogliano

Funding & Sponsors
Funding source category [1] 257440 0
Commercial sector/Industry
Name [1] 257440 0
Coherex Medical Inc.
Country [1] 257440 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Coherex Medical Inc.
Address
3598 W. 1820 S.
Salt Lake City, Utah 84104
Country
United States of America
Secondary sponsor category [1] 257151 0
None
Name [1] 257151 0
Address [1] 257151 0
Country [1] 257151 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259923 0
Health and Disability Ethics Comm--Northern X Regional EC
Ethics committee address [1] 259923 0
Ministry of Health
3rd Floor, Unisys Building
650 Great South Road, Penrose
Private Bag 92 522
Wellesley Street, Auckland, New Zealand
Ethics committee country [1] 259923 0
New Zealand
Date submitted for ethics approval [1] 259923 0
10/08/2010
Approval date [1] 259923 0
08/09/2010
Ethics approval number [1] 259923 0
NTX/10/08/079

Summary
Brief 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.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 31507 0
Address 31507 0
Country 31507 0
Phone 31507 0
Fax 31507 0
Email 31507 0
Contact person for public queries
Name 14754 0
Randall K. Jones MD
Address 14754 0
3598 W. 1820 S.
Salt Lake City, UT 84104
Country 14754 0
United States of America
Phone 14754 0
+1-801-433-9900
Fax 14754 0
+1-801-433-9901
Email 14754 0
[email protected]
Contact person for scientific queries
Name 5682 0
Randall k. Jones MD
Address 5682 0
3598 W. 1820 S.
Salt Lake City, UT 84104
Country 5682 0
United States of America
Phone 5682 0
+1-801-433-9900
Fax 5682 0
+1-801-433-9901
Email 5682 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.