Non-valvular Paroxysmal, Persistent, or Permanent Atrial FibrillationNCT02239887
Coherex WAVECREST I Left Atrial Appendage Occlusion Study
An observational study of Non-valvular Paroxysmal, Persistent, or Permanent Atrial Fibrillation and LAA Anatomy Amenable to Treatment by Percutaneous Technique, run by Coherex Medical.
Trial summary
Purpose To establish the safety and efficacy of the Coherex WaveCrest Left Atrial Appendage Occlusion System for left atrial appendage (LAA) closure during treatment of non-valvular atrial fibrillation in patients who are at increased risk for embolic stroke and have an ongoing indication for oral anticoagulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-valvular Paroxysmal, Persistent, or Permanent Atrial Fibrillation, LAA Anatomy Amenable to Treatment by Percutaneous Technique, Anticoagulation Indication for Potential Thrombus Formation in the Left Atrium
- What is being tested?
- WaveCrest LAA occlusion device
- Type of treatment
- Medical device
- How many people
- 155 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Nov 2014
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population for this study is the subset of patients who have non-valvular paroxysmal, persistent, or permanent atrial fibrillation; LAA anatomy amenable to treatment by percutaneous techniques; and an anticoagulation indication for potential thrombus formation in the left atrium. Patients with an absolute or relative contraindication to anticoagulants will also be included.
Who may be able to join
None listed.
Who cannot join
- 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.
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- 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.
About this study
Purpose To establish the safety and efficacy of the Coherex WaveCrest Left Atrial Appendage Occlusion System for left atrial appendage (LAA) closure during treatment of non-valvular atrial fibrillation in patients who are at increased risk for embolic stroke and have an ongoing indication for oral anticoagulation.
Read the 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.
- Conditions
- Non-valvular Paroxysmal, Persistent, or Permanent Atrial Fibrillation, LAA Anatomy Amenable to Treatment by Percutaneous Technique, Anticoagulation Indication for Potential Thrombus Formation in the Left Atrium
- Being tested
- WaveCrest LAA occlusion device
- Keywords
- LAA occlusion, Non-valvular Atrial Fibrillation, Percutaneous, Oral Anticoagulation, Occluder, WAVECREST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaveCrest LAA occlusion deviceDevice
Left Atrial Appendage Occlusion
| Study group | Role | What they receive |
|---|---|---|
| WaveCrest LAA occlusion device | Left Atrial Occlusion Receives: Device: WaveCrest LAA occlusion device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 45 Days post procedure
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.
Measured: 45 and/or 180 days post procedure
Secondary outcomes (2)
Secondary Safety Endpoint
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.
Measured: 180 days and one year post-procedure
Secondary Efficacy Endpoints
- Procedural success, defined as successful delivery, deployment, and release of the Coherex WaveCrest Left Atrial Appendage Occlusion System into the LAA, and includes successful recapture and retrieval, if necessary.
- The incidence of LAA occlusion as measured by echocardiographic color flow Doppler jets less than 3mm by TEE at the end of the procedure.
Measured: intra operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study startOct 2010
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-valvular Paroxysmal, Persistent, or Permanent Atrial FibrillationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coherex Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239887
- Sponsor's protocol ID
- IP005
- Status last verified
- Jan 2015
- First submitted
- 11 Sep 2014
- Last updated
- 15 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coherex WAVECREST I Left Atrial Appendage Occlusion Study
- ClinicalTrials.gov ID
- NCT02239887
- Acronym / sponsor ID
- IP005
- Conditions
- Non-valvular Paroxysmal, Persistent, or Permanent Atrial Fibrillation, LAA Anatomy Amenable to Treatment by Percutaneous Technique, Anticoagulation Indication for Potential Thrombus Formation in the Left Atrium
- Keywords
- LAA occlusion, Non-valvular Atrial Fibrillation, Percutaneous, Oral Anticoagulation, Occluder, WAVECREST
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Coherex MedicalIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 15 Sep 2014 (estimated)
- 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.
Purpose To establish the safety and efficacy of the Coherex WaveCrest Left Atrial Appendage Occlusion System for left atrial appendage (LAA) closure during treatment of non-valvular atrial fibrillation in patients who are at increased risk for embolic stroke and have an ongoing indication for oral anticoagulation.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WaveCrest LAA occlusion device | – | Device: WaveCrest LAA occlusion deviceLeft Atrial Occlusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population for this study is the subset of patients who have non-valvular paroxysmal, persistent, or permanent atrial fibrillation; LAA anatomy amenable to treatment by percutaneous techniques; and an anticoagulation indication for potential thrombus formation in the left atrium. Patients with an absolute or relative contraindication to anticoagulants will also be included.
Key inclusion criteria (0 listed)
Key exclusion criteria (25 listed)
- 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.
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 |
|---|---|---|
| WaveCrest LAA occlusion deviceLeft Atrial Appendage Occlusion | Device | WaveCrest LAA occlusion device |
Primary outcome
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.
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.
2 secondary outcomes
Secondary Safety Endpoint
Time frame: 180 days and one year post-procedure
Secondary Efficacy Endpoints
Time frame: intra operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-valvular Paroxysmal, Persistent, or Permanent Atrial Fibrillation and LAA Anatomy Amenable to Treatment by Percutaneous Technique, run by Coherex Medical.
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 0 inclusion and 25 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: finished, as of the sponsor's last update on 15 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: 45 Days post procedure). 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 15 Jan 2015.