Non-valvular Atrial FibrillationNCT03204695
WAVECREST Post Market Clinical Follow-Up (PMCF) Study
A study testing Percutaneous LAA Closure and Anticoagulation or Clopidogrel in people with Non-valvular Atrial Fibrillation, run by Coherex Medical at 1 site in Belgium.
Trial summary
The WAVECREST PMCF Study is a prospective, non-randomized, multicenter study to confirm safety and performance of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System in the current medical practice setting in patients with non-valvular atrial fibrillation who are at increased risk for stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-valvular Atrial Fibrillation
- What is being tested?
- Percutaneous LAA Closure and Anticoagulation or Clopidogrel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteBelgium
- Study dates
- 29 May 2017to 14 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Non-valvular paroxysmal, persistent, or permanent atrial fibrillation
- 18 years of age or older
- LAA anatomy amenable to treatment by percutaneous techniques
- Risk factors for potential thrombus formation in the LAA
- Willing to participate in the required follow-up visits and tests
- Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Ethics Committee or Institutional Review Board at the study site
Who cannot join
- Known contraindication to percutaneous transseptal intervention
- Left atrial appendage anatomy or size that will not allow appropriate implantation of the WaveCrest Implant
- Intracardiac thrombus or other cardiac abnormality visualized prior to implant that would significantly impact procedural safety
- Mitral valve stenosis < 1.5 cm2 or any stenosis consistent with rheumatic valvular disease or history of mitral valve replacement or repair
- Known contraindication and/or allergy to nickel
- Known active bacterial infection (i.e., sepsis, endocarditis)
- Any known medical condition or overall health of the subject that could adversely affect procedural safety or potentially prevent the patient from completing all study required visits and tests.
- Pregnant or breastfeeding women due to the risk of exposure to x-rays and medications associated with the implant procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multicenter, Non-randomized, Post-market Clinical Follow-up Study to Confirm Safety and Performance of the Coherex WaveCrest® Left Atrial Appendage Occlusion System in Patients With Non-valvular Atrial Fibrillation
The WAVECREST PMCF Study is a prospective, non-randomized, multicenter study to confirm safety and performance of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System in the current medical practice setting in patients with non-valvular atrial fibrillation who are at increased risk for stroke. Up to 65 subjects may be enrolled at up to 15 study sites in Europe. Patients will be followed through 45 days post-procedure.
Read the detailed description
The Coherex WaveCrest® Left Atrial Appendage Occlusion System is designed to permanently occlude the Left Atrial Appendage (LAA).
- Conditions
- Non-valvular Atrial Fibrillation
- Being tested
- Percutaneous LAA Closure, Anticoagulation or Clopidogrel
- Keywords
- Non-valvular atrial fibrillation, Atrial Fibrillation, Stroke, Left Atrial Appendage (LAA), LAA Closure, LAA Occlusion, WaveCrest
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous LAA ClosureDevice
LAA Closure with the WaveCrest LAA Occlusion System (study device)
Anticoagulation or ClopidogrelDrug
Subjects either continue on anticoagulation or receive clopidogrel
| Study group | Role | What they receive |
|---|---|---|
| WaveCrest® | Experimental | Implant of WaveCrest® Left Atrial Appendage Occlusion System Receives: Device: Percutaneous LAA Closure; Drug: Anticoagulation or Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With All-cause Mortality, Pericardial Effusion Requiring Intervention, Device Embolization (Major), Device Thrombus and Ischemic Stroke (Composite Primary Safety Endpoint)
The primary safety outcome was the composite of death from any cause (all-cause mortality), pericardial effusion requiring intervention, device embolization (major), device thrombus and ischemic stroke up to 45 days. The analysis was based on Sponsor Assessment of Adverse Events data. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
Measured: From baseline up to 45 days
Secondary outcomes (3)
Percentage of Participants Who Achieved Device Success
Percentage of participants who achieved device success were reported. Device success was defined as the percentage of participants who had the device deployed and implanted in the correct position. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
Measured: From baseline up to 45 days
Percentage of Participants Who Achieved Technical Success
Percentage of participants who achieved technical success were reported. Technical success was defined as the percentage of participants who experienced successful placement and release of the occluder in the LAA with LAA closure (defined as no leak greater than [>]5 millimeters [mm] on color Doppler transesophageal echocardiogram [TEE]) and who were discharged from the cardiac catheterization laboratory without the occurrence of device-related complications. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
Measured: From baseline up to 45 days
Percentage of Participants Who Achieved Procedural Success
Percentage of participants who achieved procedural success were reported. Procedural success was defined as the percentage of participants who experienced successful placement and release of the occluder in the LAA with LAA closure (defined as no leak >5 mm on color Doppler TEE) and who were discharged from the cardiac catheterization laboratory without device-related complications and without procedure-related complications other than minor device embolization (defined as device embolization that can be resolved by percutaneous technique without surgical intervention or damage to surrounding cardiovascular structures). Baseline was defined as the last available measurement on or before the date of the implantation procedure.
Measured: From baseline up to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start29 May 2017
- Primary completion14 Jun 2018
- Study completion14 Jun 2018
Why it stopped: Study closed due to device design modifications.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-valvular 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coherex Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tom De Potter, MD, Principal investigator, OLV Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204695
- Sponsor's protocol ID
- CHX_IP015
- Status last verified
- Mar 2024
- First submitted
- 16 Jun 2017
- Last updated
- 23 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Site-specific clinical study results may be published by Investigators in compliance with the Investigator Agreement and/or site agreement, as applicable.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Non-randomized, Post-market Clinical Follow-up Study to Confirm Safety and Performance of the Coherex WaveCrest® Left Atrial Appendage Occlusion System in Patients With Non-valvular Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03204695
- Acronym / sponsor ID
- CHX_IP015
- Conditions
- Non-valvular Atrial Fibrillation
- Keywords
- Non-valvular atrial fibrillation, Atrial Fibrillation, Stroke, Left Atrial Appendage (LAA), LAA Closure, LAA Occlusion, WaveCrest
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed due to device design modifications.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Coherex MedicalIndustry (pharma, biotech, devices)
- Study start
- 29 May 2017 (actual)
- Primary completion
- 14 Jun 2018 (actual)
- Study completion
- 14 Jun 2018 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Posted 23 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The WAVECREST PMCF Study is a prospective, non-randomized, multicenter study to confirm safety and performance of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System in the current medical practice setting in patients with non-valvular atrial fibrillation who are at increased risk for stroke. Up to 65 subjects may be enrolled at up to 15 study sites in Europe. Patients will be followed through 45 days post-procedure.
Detailed description
The Coherex WaveCrest® Left Atrial Appendage Occlusion System is designed to permanently occlude the Left Atrial Appendage (LAA).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WaveCrest® | Experimental | Device: Percutaneous LAA Closure, Drug: Anticoagulation or ClopidogrelImplant of WaveCrest® Left Atrial Appendage Occlusion System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Non-valvular paroxysmal, persistent, or permanent atrial fibrillation
- 18 years of age or older
- LAA anatomy amenable to treatment by percutaneous techniques
- Risk factors for potential thrombus formation in the LAA
- Willing to participate in the required follow-up visits and tests
Key exclusion criteria (8 listed)
- Known contraindication to percutaneous transseptal intervention
- Left atrial appendage anatomy or size that will not allow appropriate implantation of the WaveCrest Implant
- Intracardiac thrombus or other cardiac abnormality visualized prior to implant that would significantly impact procedural safety
- Mitral valve stenosis < 1.5 cm2 or any stenosis consistent with rheumatic valvular disease or history of mitral valve replacement or repair
- Known contraindication and/or allergy to nickel
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 |
|---|---|---|
| Percutaneous LAA ClosureLAA Closure with the WaveCrest LAA Occlusion System (study device) | Device | WaveCrest® |
| Anticoagulation or ClopidogrelSubjects either continue on anticoagulation or receive clopidogrel | Drug | WaveCrest® |
Primary outcome
Number of Participants With All-cause Mortality, Pericardial Effusion Requiring Intervention, Device Embolization (Major), Device Thrombus and Ischemic Stroke (Composite Primary Safety Endpoint)
Time frame: From baseline up to 45 days
The primary safety outcome was the composite of death from any cause (all-cause mortality), pericardial effusion requiring intervention, device embolization (major), device thrombus and ischemic stroke up to 45 days. The analysis was based on Sponsor Assessment of Adverse Events data. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
3 secondary outcomes
Percentage of Participants Who Achieved Device Success
Time frame: From baseline up to 45 days
Percentage of Participants Who Achieved Technical Success
Time frame: From baseline up to 45 days
Percentage of Participants Who Achieved Procedural Success
Time frame: From baseline up to 45 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Site-specific clinical study results may be published by Investigators in compliance with the Investigator Agreement and/or site agreement, as applicable.
Related trials for Non-valvular Atrial Fibrillation
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WATCHMAN FLX Pro European Registry
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Non Valvular Atrial Fibrillation
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.
Tom De Potter, MD principal investigator
OLV Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous LAA Closure and Anticoagulation or Clopidogrel in people with Non-valvular Atrial Fibrillation, run by Coherex Medical at 1 site in Belgium.
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 8 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: stopped early, as of the sponsor's last update on 23 Apr 2024. 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 Belgium. 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?
Yes. Results are posted in the registry (first posted 23 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With All-cause Mortality, Pericardial Effusion Requiring Intervention, Device Embolization (Major), Device Thrombus and Ischemic Stroke (Composite Primary Safety Endpoint) (time frame: From baseline up to 45 days). 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 23 Apr 2024.