Streamlined One-wire Logistics Optimize Transcatheter Aortic Valve Replacement

NCT07090811 | Not Yet Recruiting FDA Device

• 1 other identifier: 100288
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Aortic Valve Disease

Outcome Measures

Primary Outcomes (2)

• Transcatheter heart valve device migration/embolization or inability to complete BAV procedure.

  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

  Intraprocedure

• Successful deployment of THV or BAV system over the Fusion Guidewire

  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

  Intraprocedure

Study Arms (1)

Fusion System

EXPERIMENTAL

Device: Aortic valve repair/replacement

Interventions

Aortic valve repair/replacement DEVICE

TAVR or valvuloplasty using the Fusion System for delivery of the treatment system and for temporary rapid pacing

Fusion System

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for a THV or BAV procedure in accordance with standard institutional protocols requiring temporary pacing.
• Willing and able to comply with the follow-up evaluations
• 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)

You may not qualify if:

• Undergoing an emergent procedure
• An ST elevation myocardial infarction (STEMI) within 7 days of procedure
• Had cardiac arrest within 7 days of procedure requiring CPR or defibrillation
• An indication to require mechanical cardiac support (MCS) post-procedure
• Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical circulatory support within 30 days prior to index procedure
• Active endocarditis within 30 days prior to index procedure
• Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
• Severe aortic annular or sub annular calcium per operator evaluation.
• Bicuspid aortic valve stenosis WITH severe raphe calcium per operator evaluation.
• Had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 90 days of index procedure
• Severe peripheral vascular disease that would preclude safe placement of an introducer sheath
• A planned alternative (i.e., non-femoral) access site
• A comorbidity that would preclude index procedure or use of the Solo Pace Fusion System
• A known, untreated neurological, psychological, psychiatric or other disorder that would interfere with trial endpoints or with cooperation with the requirements of the trial
• Participating in another investigational drug or device study

Sponsors & Collaborators

• Solo Pace, Inc.: lead

MeSH Terms

Conditions

Aortic Valve Disease

Interventions

Replantation

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 29, 2025
• Study Start: September 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-07