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Not yet recruiting NCT07090811

Streamlined One-wire Logistics Optimize Transcatheter Aortic Valve Replacement

No phase Interventional Aortic Valve Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aortic valve repair/replacement.
Who it may be relevant to
Registry conditions: Aortic Valve Disease. Basic parameters: 21 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Device Aortic valve repair/replacement
    TAVR or valvuloplasty using the Fusion System for delivery of the treatment system and for temporary rapid pacing

Primary outcome measures

  • Transcatheter heart valve device migration/embolization or inability to complete BAV procedure. [Time frame: Intraprocedure]
  • Successful deployment of THV or BAV system over the Fusion Guidewire [Time frame: Intraprocedure]

Eligibility criteria

Inclusion criteria

  • 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)

Exclusion criteria

  • 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
  • Pregnant, lactating, or plan to become pregnant during the study (women of child-bearing potential must have a pregnancy test).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07090811 · 100288

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗