Mini-invasive Balloon Aortic Valvuloplasty

NCT ID: NCT03087552

Last Updated: 2021-04-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 361 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-11
• Study Completion Date: 2021-04-20

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.

Conditions

Aortic Valve Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Transradial balloon aortic valvuloplasty

Consecutive patients with severe aortic stenosis and receiving as first attempt balloon aortic valvuloplasty by transradial access.

Transradial balloon aortic valvuloplasty

Intervention Type: PROCEDURE

Mini-invasive balloon aortic valvuloplasty consisting in transradial access

Transradial balloon aortic valvuloplasty

Intervention Type: PROCEDURE

Rapid pacing using the 0.035-in. retrograde left ventricular support wire

Interventions

Transradial balloon aortic valvuloplasty

Mini-invasive balloon aortic valvuloplasty consisting in transradial access

Intervention Type: PROCEDURE

Transradial balloon aortic valvuloplasty

Rapid pacing using the 0.035-in. retrograde left ventricular support wire

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• severe symptomatic aortic stenosis requiring balloon aortic valvuloplasty

Exclusion Criteria

• cardiogenic shock
• bilateral absence of radial pulse

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Gianluca Campo

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital of Ferrara

Cona, Ferrara, Italy

Pia Fondazione Panico

Tricase, Lecce, Italy

Ospedale Bassini

Cinisello Balsamo, Milano, Italy

AOU San Luigi Gonzaga

Orbassano, Torino, Italy

Ospedale di Conegliano

Conegliano, Treviso, Italy

AOU di Ancona

Ancona, , Italy

AOU di Bologna

Bologna, , Italy

Ospedale Morgagni Pierantoni

Forlì, , Italy

Ospedale Misericordia

Grosseto, , Italy

Ospedale Vito Fazzi

Lecce, , Italy

Ospedale Civile Santo Spirito

Pescara, , Italy

Ospedale Santa Maria delle Croci

Ravenna, , Italy

Ospedale degli Infermi

Rimini, , Italy

Ospedale San Giovanni di Dio e Ruggi d'Aragona

Salerno, , Italy

Ospedale di Sassari

Sassari, , Italy

ASL di Teramo

Teramo, , Italy

Ospedale degli Infermi di Rivoli

Torino, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 25127334 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27726292 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33627400 (View on PubMed)

Other Identifiers

18072011

Identifier Type: -

Identifier Source: org_study_id