Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Alfred
About this trial
The goal of this clinical trial is to discover if routine 'double tap' balloon post-dilation improves valve expansion and clinical outcomes in adults undergoing Transcatheter Aortic Valve Implantation (TAVI) with the SAPIEN balloon-expandable TAVI prosthesis.
The primary hypothesis is that routine 'double tap' balloon post-dilation improves TAVI valve expansion. The secondary hypothesis is that routine 'double tap' balloon post-dilation improves TAVI valve haemodynamic performance.
Participants will be randomised to balloon-expandable TAVI either with or without routine 'double tap' balloon post-dilation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Severe aortic stenosis undergoing trans-femoral TAVI using the SAPIEN 3 Ultra/RESILIA balloon-expandable transcatheter heart valve.
Tricuspid or bicuspid aortic valve stenosis
Disqualifiers
Valve-in-valve TAVI for failure of an existing prosthetic surgical or transcatheter valve failure
TAVI performed for native valve aortic regurgitation
High risk 'hostile' annular anatomy as adjudicated by multidisciplinary Heart Team based on pre-procedure CT anatomy.
Trial design
Design model
Parallel
Treatments tested in this trial
'Double tap' balloon post-dilation
Other interventionRoutine second inflation of the valve delivery balloon ('double-tap') BPD following balloon-expandable valve TAVI
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Routine deploymentNo intervention 0 interventions
Group B: Routine double tapExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Fluoroscopic valve expansion
Percentage (%) final valve expansion measured by fluoroscopy
Time frame
Day 1 post-procedureSecondary outcomes
1
Haemodynamic performance
Echocardiographic transvalvular mean pressure gradient (mmHg)
Time frame
Day 1-3 post-procedure2
Haemodynamic performance
Echocardiographic aortic valve area (cmsq)
Time frame
Day 1-3 post-procedure3
Freedom from cardiovascular death or valve reintervention
Freedom from occurrence of composite of cardiovascular death or valve reintervention
Time frame
1 year and 3 years post-procedureOther outcomes
1
CT sub-study: final valve expansion measured by non-contrast computed tomography
CT sub-study: final valve expansion (%) measured by non-contrast computed tomography
Time frame
30-90 days post-procedure2
New permanent pacemaker implantation
New permanent pacemaker implantation
Time frame
30 days post-procedure3
Stroke
Confirmed stroke
Time frame
30 days post-procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Alfred
Lead sponsor
Edwards Lifesciences
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: