Streamlined One-wire Logistics Optimize Transcatheter Aortic Valve Replacement
ConditionAortic Valve Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-85
SponsorSolo Pace, Inc.
About this trial
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).
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Aortic valve repair/replacement
Treatment groups
20 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov