Clinical trial NCT03087552: Mini-invasive Balloon Aortic Valvuloplasty
Official title: Safety and Feasibility of Transradial Mini-invasive Balloon Aortic Valvuloplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 361
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with severe aortic stenosis with indication to balloon aortic valvuloplasty

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* severe symptomatic aortic stenosis requiring balloon aortic valvuloplasty

Exclusion Criteria:

* cardiogenic shock
* bilateral absence of radial pulse

Primary outcomes:
measure: Vascular complications
timeFrame: 1 month
Secondary outcomes:
measure: Transradial balloon aortic valvuloplasty major complications
timeFrame: 1 month
measure: Adverse events
timeFrame: 1 month
measure: Major vascular complications
timeFrame: 1 month
measure: Minor vascular complications
timeFrame: 1 month
measure: Radial artery occlusion
timeFrame: 1 month
measure: Radial artery occlusion
timeFrame: 24 hours
Other outcomes:
measure: Frailty assessment
timeFrame: 1 month
measure: Physical performance assessment
timeFrame: 1 month
measure: Essential Frailty Toolset
timeFrame: 1 month
Locations:
city: Cona
country: Italy
facility: University Hospital of Ferrara
state: Ferrara
city: Tricase
country: Italy
facility: Pia Fondazione Panico
state: Lecce
city: Cinisello Balsamo
country: Italy
facility: Ospedale Bassini
state: Milano
city: Orbassano
country: Italy
facility: AOU San Luigi Gonzaga
state: Torino
city: Conegliano
country: Italy
facility: Ospedale di Conegliano
state: Treviso
city: Ancona
country: Italy
facility: AOU di Ancona
city: Bologna
country: Italy
facility: AOU di Bologna
city: Forlì
country: Italy
facility: Ospedale Morgagni Pierantoni
city: Grosseto
country: Italy
facility: Ospedale Misericordia
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi
city: Pescara
country: Italy
facility: Ospedale Civile Santo Spirito
city: Ravenna
country: Italy
facility: Ospedale Santa Maria delle Croci
city: Rimini
country: Italy
facility: Ospedale degli Infermi
city: Salerno
country: Italy
facility: Ospedale San Giovanni di Dio e Ruggi d'Aragona
city: Sassari
country: Italy
facility: Ospedale di Sassari
city: Teramo
country: Italy
facility: ASL di Teramo
city: Torino
country: Italy
facility: Ospedale degli Infermi di Rivoli
Study officials:
References:
citation: Tumscitz C, Pirani L, Tebaldi M, Campo G, Biscaglia S. Seven french radial artery access for PCI: a prospective single-center experience. Int J Cardiol. 2014 Oct 20;176(3):1074-5. doi: 10.1016/j.ijcard.2014.07.134. Epub 2014 Aug 2. No abstract available.
citation: Hilling-Smith R, Cockburn J, Dooley M, Parker J, Newton A, Hill A, Trivedi U, de Belder A, Hildick-Smith D. Rapid pacing using the 0.035-in. Retrograde left ventricular support wire in 208 cases of transcatheter aortic valve implantation and balloon aortic valvuloplasty. Catheter Cardiovasc Interv. 2017 Mar 1;89(4):783-786. doi: 10.1002/ccd.26720. Epub 2016 Oct 11.
citation: Tumscitz C, Di Cesare A, Balducelli M, Piva T, Santarelli A, Saia F, Tarantino F, Preti G, Picchi A, Rolfo C, Attisano T, Colonna G, De Iaco G, Parodi G, Di Marco M, Cerrato E, Pierini S, Fileti L, Cavazza C, Dall'Ara G, Govoni B, Mantovani G, Serenelli M, Penzo C, Tebaldi M, Campo G, Biscaglia S. Safety, efficacy and impact on frailty of mini-invasive radial balloon aortic valvuloplasty. Heart. 2021 Jun;107(11):874-880. doi: 10.1136/heartjnl-2020-318548. Epub 2021 Feb 24.