Aortic Valve Disease
Conditions
Brief summary
The goal of this study is to determine the safety and performance of a new guidewire and pacing system called the Fusion System in treating patients undergoing transcatheter aortic valve replacement (TAVR) or similar procedures. The main questions it aims to answer are: Is the Fusion System safe? Is the Fusion System's clinical performance acceptable? Participants will asked to sign a study consent and report any adverse events experienced until they are discharged from hospital (or a maximum of 2 days following their procedure).
Interventions
DEVICEAortic valve repair/replacement
TAVR or valvuloplasty using the Fusion System for delivery of the treatment system and for temporary rapid pacing
Sponsors
Solo Pace, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Scheduled for a THV or BAV procedure in accordance with standard institutional protocols requiring temporary pacing. 2. Willing and able to comply with the follow-up evaluations 3. Been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)
Exclusion criteria
1. Undergoing an emergent procedure 2. An ST elevation myocardial infarction (STEMI) within 7 days of procedure 3. Had cardiac arrest within 7 days of procedure requiring CPR or defibrillation 4. An indication to require mechanical cardiac support (MCS) post-procedure 5. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical circulatory support within 30 days prior to index procedure 6. Active endocarditis within 30 days prior to index procedure 7. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation 8. Severe aortic annular or sub annular calcium per operator evaluation. 9. Bicuspid aortic valve stenosis WITH severe raphe calcium per operator evaluation. 10. Had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 90 days of index procedure 11. Severe peripheral vascular disease that would preclude safe placement of an introducer sheath 12. A planned alternative (i.e., non-femoral) access site 13. A comorbidity that would preclude index procedure or use of the Solo Pace Fusion System 14. A known, untreated neurological, psychological, psychiatric or other disorder that would interfere with trial endpoints or with cooperation with the requirements of the trial 15. Participating in another investigational drug or device study 16. Pregnant, lactating, or plan to become pregnant during the study (women of child-bearing potential must have a pregnancy test).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transcatheter heart valve device migration/embolization or inability to complete BAV procedure. | Intraprocedure | Incidence of failure of the Solo Pace Fusion System to provide adequate pacing leading to transcatheter heart valve device migration/embolization or the inability to complete the BAV procedure |
| Successful deployment of THV or BAV system over the Fusion Guidewire | Intraprocedure | The Primary Performance Endpoint for the study consists of the following criteria (note: both criteria must be met): * Successful delivery to the intended position and successful deployment of a commercially available THV or BAV delivery system over the Fusion Guidewire * Successful pacing during THV or BAV deployment in unipolar configuration using the Fusion System |
Outcome results
None listed