Mini-invasive Balloon Aortic Valvuloplasty

Completed

• Conditions: Aortic Valve Stenosis
• Interventions: Procedure: Transradial balloon aortic valvuloplasty

• Registration Number: NCT03087552
• Lead Sponsor: University Hospital of Ferrara

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.

Study Timeline

• Study Start: 2017-03-11
• Study First Submitted: 2017-03-11
• Study First Submitted QC: 2017-03-16
• Study First Posted: 2017-03-22
• Primary Completion: 2020-01-07
• Status Verified: 2021-04
• Study Completion: 2021-04-20
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 361

Inclusion Criteria

• severe symptomatic aortic stenosis requiring balloon aortic valvuloplasty

Exclusion Criteria

• cardiogenic shock
• bilateral absence of radial pulse

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Vascular complications	1 month	Cumulative occurrence of major and minor bleeding complications according the VARC-2 classification

Secondary Outcome Measures

Name	Time	Method
Major vascular complications	1 month	Cumulative occurrence of major bleeding complications according the VARC-2
Minor vascular complications	1 month	Cumulative occurrence of minor bleeding complications according the VARC-2
Transradial balloon aortic valvuloplasty major complications	1 month	Balloon entrapment, compartment syndrome requiring surgical intervention
Radial artery occlusion	24 hours	Cumulative occurrence of radial artery occlusion
Adverse events	1 month	Cumulative occurrence of death, stroke, coronary occlusion, coronary dissection, moderate-severe aortic regurgitation, severe hypotension requiring intervention, pericardiocentesis, definitive pace-maker implantation

Trial Locations

Locations (17)

AOU di Ancona; 🇮🇹 Ancona, Italy

University Hospital of Ferrara; 🇮🇹 Cona, Ferrara, Italy

Ospedale Vito Fazzi; 🇮🇹 Lecce, Italy

Ospedale Bassini; 🇮🇹 Cinisello Balsamo, Milano, Italy

AOU San Luigi Gonzaga; 🇮🇹 Orbassano, Torino, Italy

AOU di Bologna; 🇮🇹 Bologna, Italy

Ospedale Morgagni Pierantoni; 🇮🇹 Forlì, Italy

Ospedale Misericordia; 🇮🇹 Grosseto, 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

Pia Fondazione Panico; 🇮🇹 Tricase, Lecce, Italy

Ospedale di Conegliano; 🇮🇹 Conegliano, Treviso, Italy