Streamlined One-wire Logistics Optimize Transcatheter Aortic Valve Replacement

NCT ID: NCT07090811

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-04-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fusion System

Group Type: EXPERIMENTAL

Aortic valve repair/replacement

Intervention Type: DEVICE

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

Interventions

Aortic valve repair/replacement

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

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Solo Pace, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

100288

Identifier Type: -

Identifier Source: org_study_id