Atrial Arrhythmia, Atrial Fibrillation, Atrial Septal Defect, Left Atrial Appendage Closure
Conditions
Brief summary
The objective of the study is to evaluate the performance of the VERAFEYE System in subjects entitled to undergo a standard of care ablation or closure procedure. Results from this study will be used to guide development and refinement the VERAFEYE System. The study is not designed to collect data for product approval and as such does not have a safety or efficacy endpoint.
Interventions
DEVICEVERAFEYE System
The VERAFEYE System will be used during standard of care, catheter-based treatments for atrial flutter or atrial fibrillation; or left atrial appendage/atrial septal defect closure procedures.
Sponsors
LUMA Vision Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Subject is 18 to 80 years of age at the time of consent * Subject is scheduled to undergo a standard of care, de-novo catheter-ablation procedure to treat typical AFL or AF; or left atrial appendage (LAA)/ atrial septal defect (ASD) closure procedure * Subject is able to understand and willing to provide written informed consent Key
Exclusion criteria
* Any of the following within 6 months prior to enrolment: * Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotomy * Thromboembolic event (stroke), transient ischemic attack (TIA) or neurological disturbances * Myocardial infarction * Any surgical or percutaneous cardiac procedure including coronary intervention and cardiac ablation * Dilated or hypertropic cardiomyopathy * Any planned surgical or endovascular intervention within 30 days before or after the ablation, or LAA/ASD closure procedure. * Any of the following cardiac conditions: * New York Heart Association (NYHA) class IV * Left ventricular ejection fraction (LVEF) \< 30% * Implanted with a cardiac rhythm management device (pacemaker, CRT, ICD, loop recorder) * Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation * Active coronary ischemia, significant valvular heart disease, or hemodynamically significant congenital cardiac abnormality * Body mass index (BMI) \> 40 kg/m2 * Body weight \< 50kg * Pregnant women or women who plan to become pregnant during the course of their participation in the study (women should either be of non- childbearing potential at the time of enrolment (as documented in the medical file) or have a negative pregnancy test within the previous 7 days prior to the ablation, or LAA/ASD closure procedure) * Life expectancy less than 12 months * Subjects who are currently enrolled in another study * Subjects with a thrombus or pericardial effusion detected in the LA/LAA during standard of care imaging
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician Feedback on VERAFEYE System | During the procedure (up to two hours) | The objective of the study is to collect physician feedback by means of a questionnaire on the VERAFEYE System. Results from this study may be used to guide development and refinement of the VERAFEYE System. |
Countries
Ireland
Participant flow
Recruitment details
Of 18 enrolled participants, 17 underwent catheter ablation procedure with VERAFEYE System.
Pre-assignment details
1 of 18 enrolled subjects was classified as an intent subject (no VERAFEYE Imaging Catheter inserted into the body).
Baseline characteristics
| Characteristic | — |
|---|---|
| 12-lead ECG at Baseline Atrial Fibrillation | 7 Participants |
| 12-lead ECG at Baseline Atrial Fibrillation AND Atrial Flutter | 1 Participants |
| 12-lead ECG at Baseline Atrial Flutter | 2 Participants |
| 12-lead ECG at Baseline Sinus Rhythm | 7 Participants |
| Age, Continuous | 66.2 years STANDARD_DEVIATION 7.3 |
| Diastolic BP | 85.6 mmHg STANDARD_DEVIATION 13.8 |
| Height | 176.9 cm STANDARD_DEVIATION 11.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment Ireland | 17 participants |
| Resting Heart Rate | 75.8 bpm STANDARD_DEVIATION 18.7 |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 14 Participants |
| Systolic BP | 135.4 mmHg STANDARD_DEVIATION 21.1 |
| Weight | 91.2 kg STANDARD_DEVIATION 15.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
None listed