Aortic Valve DiseaseSOLO-TAVRNCT07090811
Streamlined One-wire Logistics Optimize Transcatheter Aortic Valve Replacement
A study testing Aortic valve repair/replacement in people with Aortic Valve Disease, run by Solo Pace, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Aortic Valve Disease
- What is being tested?
- Aortic valve repair/replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 16Show fewer
- 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
- Pregnant, lactating, or plan to become pregnant during the study (women of child-bearing potential must have a pregnancy test).
About this study
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
- Being tested
- Aortic valve repair/replacement
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic valve repair/replacementDevice
TAVR or valvuloplasty using the Fusion System for delivery of the treatment system and for temporary rapid pacing
| Study group | Role | What they receive |
|---|---|---|
| Fusion System | Experimental | Not described Receives: Device: Aortic valve repair/replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Intraprocedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study startSep 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Solo Pace, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090811
- Sponsor's protocol ID
- 100288
- Acronym
- SOLO-TAVR
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Streamlined One-wire Logistics Optimize Transcatheter Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT07090811
- Acronym / sponsor ID
- SOLO-TAVR / 100288
- Conditions
- Aortic Valve Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Solo Pace, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fusion System | Experimental | Device: Aortic valve repair/replacement |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aortic valve repair/replacementTAVR or valvuloplasty using the Fusion System for delivery of the treatment system and for temporary rapid pacing | Device | Fusion System |
Primary outcome
Transcatheter heart valve device migration/embolization or inability to complete BAV procedure.
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
Related trials for Aortic Valve Disease
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Not yet recruitingPhase 4
Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)
Aortic Stenosis, Severe Aortic Stenosis
Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Aortic valve repair/replacement in people with Aortic Valve Disease, run by Solo Pace, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcatheter heart valve device migration/embolization or inability to complete BAV procedure. (time frame: Intraprocedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.