Streamlined One-wire Logistics Optimize Transcatheter Aortic Valve Replacement (SOLO-TAVR)

Solo Pace, Inc.

Status: Not yet enrolling

Conditions: Aortic Valve Disease

Treatments: Device: Aortic valve repair/replacement

Study type: Interventional

Funder types: Industry

Identifiers

NCT07090811

100288

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Fusion System

Experimental group

Treatment:

Device: Aortic valve repair/replacement