Mini-invasive Balloon Aortic Valvuloplasty

Aortic Valve Stenosis Clinical Trial

— SOFTLY-II  

Official title:

Safety and Feasibility of Transradial Mini-invasive Balloon Aortic Valvuloplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03087552
• Other study ID #: 18072011
• Status: Completed
• Start date: March 11, 2017
• Est. completion date: April 20, 2021

Study information

• Verified date: April 2021
• Source: University Hospital of Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 361
• Est. completion date: April 20, 2021
• Est. primary completion date: January 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• severe symptomatic aortic stenosis requiring balloon aortic valvuloplasty

Exclusion Criteria:

• cardiogenic shock

• bilateral absence of radial pulse

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Procedure:
• Transradial balloon aortic valvuloplasty
Mini-invasive balloon aortic valvuloplasty consisting in transradial access
• Transradial balloon aortic valvuloplasty
Rapid pacing using the 0.035-in. retrograde left ventricular support wire

Locations

Country	Name	City	State
Italy	AOU di Ancona	Ancona
Italy	AOU di Bologna	Bologna
Italy	Ospedale Bassini	Cinisello Balsamo	Milano
Italy	University Hospital of Ferrara	Cona	Ferrara
Italy	Ospedale di Conegliano	Conegliano	Treviso
Italy	Ospedale Morgagni Pierantoni	Forlì
Italy	Ospedale Misericordia	Grosseto
Italy	Ospedale Vito Fazzi	Lecce
Italy	AOU San Luigi Gonzaga	Orbassano	Torino
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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	1 month
Other	Physical performance assessment	Improvement from baseline to 1 month of grip strength	1 month
Other	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	1 month
Primary	Vascular complications	Cumulative occurrence of major and minor bleeding complications according the VARC-2 classification	1 month
Secondary	Transradial balloon aortic valvuloplasty major complications	Balloon entrapment, compartment syndrome requiring surgical intervention	1 month
Secondary	Adverse events	Cumulative occurrence of death, stroke, coronary occlusion, coronary dissection, moderate-severe aortic regurgitation, severe hypotension requiring intervention, pericardiocentesis, definitive pace-maker implantation	1 month
Secondary	Major vascular complications	Cumulative occurrence of major bleeding complications according the VARC-2	1 month
Secondary	Minor vascular complications	Cumulative occurrence of minor bleeding complications according the VARC-2	1 month
Secondary	Radial artery occlusion	Cumulative occurrence of radial artery occlusion	1 month
Secondary	Radial artery occlusion	Cumulative occurrence of radial artery occlusion	24 hours