Trial Outcomes & Findings for WAVECREST Post Market Clinical Follow-Up (PMCF) Study (NCT NCT03204695)
NCT ID: NCT03204695
Last Updated: 2024-04-23
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
From baseline up to 45 days
Results posted on
2024-04-23
Participant Flow
Participant milestones
| Measure |
Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System
In eligible participants, Coherex WaveCrest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a transseptal puncture into the LAA.
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|---|---|
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Overall Study
STARTED
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27
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Overall Study
Treated: Intent-to-treat (ITT) Analysis Set
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24
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Overall Study
COMPLETED
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23
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Overall Study
NOT COMPLETED
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4
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Reasons for withdrawal
| Measure |
Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System
In eligible participants, Coherex WaveCrest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a transseptal puncture into the LAA.
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Overall Study
Death
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1
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Overall Study
Participant was treated with another device
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1
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Overall Study
Physician Decision
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2
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Baseline Characteristics
WAVECREST Post Market Clinical Follow-Up (PMCF) Study
Baseline characteristics by cohort
| Measure |
Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System
n=24 Participants
In eligible participants, Coherex WaveCrest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a transseptal puncture into the LAA.
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|---|---|
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Age, Continuous
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75.8 Years
STANDARD_DEVIATION 7.9 • n=5 Participants
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Sex: Female, Male
Female
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8 Participants
n=5 Participants
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Sex: Female, Male
Male
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16 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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23 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: From baseline up to 45 daysPopulation: The intent-to-treat (ITT) analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein.
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.
Outcome measures
| Measure |
Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System
n=24 Participants
In eligible participants, Coherex WaveCrest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a transseptal puncture into the LAA.
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Number of Participants With All-cause Mortality, Pericardial Effusion Requiring Intervention, Device Embolization (Major), Device Thrombus and Ischemic Stroke (Composite Primary Safety Endpoint)
All-cause mortality
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2 Participants
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Number of Participants With All-cause Mortality, Pericardial Effusion Requiring Intervention, Device Embolization (Major), Device Thrombus and Ischemic Stroke (Composite Primary Safety Endpoint)
Pericardial effusion requiring intervention
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2 Participants
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Number of Participants With All-cause Mortality, Pericardial Effusion Requiring Intervention, Device Embolization (Major), Device Thrombus and Ischemic Stroke (Composite Primary Safety Endpoint)
Device embolization (major)
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1 Participants
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Number of Participants With All-cause Mortality, Pericardial Effusion Requiring Intervention, Device Embolization (Major), Device Thrombus and Ischemic Stroke (Composite Primary Safety Endpoint)
Device thrombus
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0 Participants
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Number of Participants With All-cause Mortality, Pericardial Effusion Requiring Intervention, Device Embolization (Major), Device Thrombus and Ischemic Stroke (Composite Primary Safety Endpoint)
Ischemic stroke
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0 Participants
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SECONDARY outcome
Timeframe: From baseline up to 45 daysPopulation: The ITT analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein.
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.
Outcome measures
| Measure |
Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System
n=24 Participants
In eligible participants, Coherex WaveCrest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a transseptal puncture into the LAA.
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|---|---|
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Percentage of Participants Who Achieved Device Success
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83.3 Percentage of Participants
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SECONDARY outcome
Timeframe: From baseline up to 45 daysPopulation: The ITT analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein.
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.
Outcome measures
| Measure |
Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System
n=24 Participants
In eligible participants, Coherex WaveCrest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a transseptal puncture into the LAA.
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|---|---|
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Percentage of Participants Who Achieved Technical Success
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79.2 Percentage of Participants
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SECONDARY outcome
Timeframe: From baseline up to 45 daysPopulation: The ITT analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein.
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.
Outcome measures
| Measure |
Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System
n=24 Participants
In eligible participants, Coherex WaveCrest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a transseptal puncture into the LAA.
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|---|---|
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Percentage of Participants Who Achieved Procedural Success
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75.0 Percentage of Participants
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Adverse Events
Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System
Serious events: 6 serious events
Other events: 6 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System
n=24 participants at risk
In eligible participants, Coherex WaveCrest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a transseptal puncture into the LAA.
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Cardiac disorders
Acute myocardial infarction
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4.2%
1/24 • Number of events 1 • From baseline up to 45 days
The intent-to-treat (ITT) analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
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Cardiac disorders
Cardiac aneurysm
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4.2%
1/24 • Number of events 1 • From baseline up to 45 days
The intent-to-treat (ITT) analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
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Cardiac disorders
Cardiac failure
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4.2%
1/24 • Number of events 1 • From baseline up to 45 days
The intent-to-treat (ITT) analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
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Cardiac disorders
Cardiac tamponade
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8.3%
2/24 • Number of events 2 • From baseline up to 45 days
The intent-to-treat (ITT) analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
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Cardiac disorders
Mitral valve incompetence
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4.2%
1/24 • Number of events 1 • From baseline up to 45 days
The intent-to-treat (ITT) analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
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General disorders
Device embolization
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4.2%
1/24 • Number of events 1 • From baseline up to 45 days
The intent-to-treat (ITT) analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
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General disorders
Multiple organ dysfunction syndrome
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4.2%
1/24 • Number of events 1 • From baseline up to 45 days
The intent-to-treat (ITT) analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
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Infections and infestations
Candida infection
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4.2%
1/24 • Number of events 1 • From baseline up to 45 days
The intent-to-treat (ITT) analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
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Infections and infestations
Pneumococcal sepsis
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4.2%
1/24 • Number of events 1 • From baseline up to 45 days
The intent-to-treat (ITT) analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
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Infections and infestations
Septic shock
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4.2%
1/24 • Number of events 1 • From baseline up to 45 days
The intent-to-treat (ITT) analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
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Injury, poisoning and procedural complications
Arterial injury
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4.2%
1/24 • Number of events 1 • From baseline up to 45 days
The intent-to-treat (ITT) analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
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Injury, poisoning and procedural complications
Femoral neck fracture
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4.2%
1/24 • Number of events 1 • From baseline up to 45 days
The intent-to-treat (ITT) analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
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Nervous system disorders
Seizure
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4.2%
1/24 • Number of events 1 • From baseline up to 45 days
The intent-to-treat (ITT) analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
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Renal and urinary disorders
Acute kidney injury
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4.2%
1/24 • Number of events 1 • From baseline up to 45 days
The intent-to-treat (ITT) analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
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Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
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4.2%
1/24 • Number of events 1 • From baseline up to 45 days
The intent-to-treat (ITT) analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
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Respiratory, thoracic and mediastinal disorders
Epistaxis
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4.2%
1/24 • Number of events 1 • From baseline up to 45 days
The intent-to-treat (ITT) analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
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Other adverse events
| Measure |
Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System
n=24 participants at risk
In eligible participants, Coherex WaveCrest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a transseptal puncture into the LAA.
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|---|---|
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Respiratory, thoracic and mediastinal disorders
Epistaxis
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8.3%
2/24 • Number of events 2 • From baseline up to 45 days
The intent-to-treat (ITT) analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
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Infections and infestations
Influenza
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4.2%
1/24 • Number of events 1 • From baseline up to 45 days
The intent-to-treat (ITT) analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
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Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
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4.2%
1/24 • Number of events 1 • From baseline up to 45 days
The intent-to-treat (ITT) analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
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Vascular disorders
Hypertension
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4.2%
1/24 • Number of events 1 • From baseline up to 45 days
The intent-to-treat (ITT) analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
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Renal and urinary disorders
Haematuria
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4.2%
1/24 • Number of events 1 • From baseline up to 45 days
The intent-to-treat (ITT) analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
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Infections and infestations
Erysipelas
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4.2%
1/24 • Number of events 1 • From baseline up to 45 days
The intent-to-treat (ITT) analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
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Additional Information
Senior Director Clinical Research
Coherex Medical, Inc.
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Results of this clinical study may be submitted for publication without regard for whether the trial results are positive or negative. Sponsor will be responsible for oversight of the publication process and will have oversight of publications of results of the trial, the Physician Advisory Committee may advise.
- Publication restrictions are in place
Restriction type: OTHER