An observational study in Aortic Valve Stenosis, sponsored by University Hospital of Ferrara. Completed at 17 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-29.
Sponsored by University Hospital of Ferrara · Observational
The spreading of transcatheter aortic valve implantation has paradoxically increased the spectrum of indications for balloon aortic valvuloplasty. Balloon aortic valvuloplasty is currently used as destination therapy for patients excluded from transcatheter aortic valve implantation, as bridge to transcatheter aortic valve implantation or to surgical aortic valve replacement, or as a stratification tool for selected high-risk patients who cannot be immediate candidates for transcatheter aortic valve implantation. Moreover, it has been recently showed that transcatheter aortic valve implantation without balloon aortic valvuloplasty is encumbered by an increased risk of cerebral embolization. However, balloon aortic valvuloplasty has a complication rate comparable to transcatheter aortic valve implantation, mainly related to access site or temporary pacemaker implantation. Thus, a transradial mini-invasive approach with rapid pacing through the 0,035 inch left ventricular support wire could be extremely appealing.
Consecutive patients with severe aortic stenosis with indication to aortic balloon valvuloplasty will be enrolled. An ad hoc informed consent for the procedure will be obtained from all patients.
This is a prospective observational study. The Investigators will include patients where aortic ballloon valvuloplasty is attempted by radial access and without temporary pacemaker implantation. The aim is to register and monitor the effectiveness and safety of this approach. Details regarding management of radial access and pacing with 0.035 wire can be found in the references reported below. The primary endpoint will be the 30-day occurence of minor and major vascular complications according VARC 2 classification. The safety endpoint will be the absence of intra- or periprocedural major complications in transradial balloon aortic valvuloplasty, namely balloon entrapment or compartment syndrome requiring surgical intervention.
The feasibility endpoint will be a procedural success rate ≥90%. The efficacy endpoint will be a reduction of the mean invasive gradient >30%. At baseline, Handgrip strength test will be performed and angiography of the instrumented arm will be performed at the beginning and at the end of the procedure. All patients will be prospectively followed-up for at least 30 days and all adverse events will be recorded. All patients will be assessed also for frailty according the clinical frailty scale (CFS). During the 30-day follow-up visit two independent blinded operators will evaluate radial artery patency by ultrasonography and perform handgrip strength test in in both arms in all patients.
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's enrollment of 361 is above the median of 200 across 424 observational studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →University Hospital of Ferrara is the lead sponsor of 110 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients with severe aortic stenosis with indication to balloon aortic valvuloplasty
Exclusion Criteria:
Consecutive patients with severe aortic stenosis and receiving as first attempt balloon aortic valvuloplasty by transradial access.
Procedure: Transradial balloon aortic valvuloplasty
Mini-invasive balloon aortic valvuloplasty consisting in transradial access
Rapid pacing using the 0.035-in. retrograde left ventricular support wire
Vascular complications
Cumulative occurrence of major and minor bleeding complications according the VARC-2 classification
Time frame: 1 month
Transradial balloon aortic valvuloplasty major complications
Balloon entrapment, compartment syndrome requiring surgical intervention
Time frame: 1 month
Adverse events
Cumulative occurrence of death, stroke, coronary occlusion, coronary dissection, moderate-severe aortic regurgitation, severe hypotension requiring intervention, pericardiocentesis, definitive pace-maker implantation
Time frame: 1 month
Major vascular complications
Cumulative occurrence of major bleeding complications according the VARC-2
Time frame: 1 month
Minor vascular complications
Cumulative occurrence of minor bleeding complications according the VARC-2
Time frame: 1 month
Radial artery occlusion
Cumulative occurrence of radial artery occlusion
Time frame: 1 month
Radial artery occlusion
Cumulative occurrence of radial artery occlusion
Time frame: 24 hours
Frailty assessment
Improvement from baseline to 1 month of the Clinical Frailty Scale. The Clinical Frailty Scale (CFS) ranges from 1 to 9, with higher values suggestive for poor prognosis
Time frame: 1 month
Physical performance assessment
Improvement from baseline to 1 month of grip strength
Time frame: 1 month
Essential Frailty Toolset
Improvement from baseline to 1 month of the value of the Essential Frailty Toolset scale. The Essential Frailty Toolset (EFT) ranges from 0 to 5, with higher values suggestive for poor prognosis
Time frame: 1 month
Plan to share: Undecided
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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University Hospital of Ferrara