Mini-invasive Balloon Aortic Valvuloplasty
SOFTLY-II
Safety and Feasibility of Transradial Mini-invasive Balloon Aortic Valvuloplasty
1 other identifier
observational
361
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2017
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2017
CompletedStudy Start
First participant enrolled
March 11, 2017
CompletedFirst Posted
Study publicly available on registry
March 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2021
CompletedApril 29, 2021
April 1, 2021
2.8 years
March 11, 2017
April 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Vascular complications
Cumulative occurrence of major and minor bleeding complications according the VARC-2 classification
1 month
Secondary Outcomes (6)
Transradial balloon aortic valvuloplasty major complications
1 month
Adverse events
1 month
Major vascular complications
1 month
Minor vascular complications
1 month
Radial artery occlusion
1 month
- +1 more secondary outcomes
Other Outcomes (3)
Frailty assessment
1 month
Physical performance assessment
1 month
Essential Frailty Toolset
1 month
Study Arms (1)
Transradial balloon aortic valvuloplasty
Consecutive patients with severe aortic stenosis and receiving as first attempt balloon aortic valvuloplasty by transradial access.
Interventions
Mini-invasive balloon aortic valvuloplasty consisting in transradial access
Eligibility Criteria
patients with severe aortic stenosis with indication to balloon aortic valvuloplasty
You may qualify if:
- severe symptomatic aortic stenosis requiring balloon aortic valvuloplasty
You may not qualify if:
- cardiogenic shock
- bilateral absence of radial pulse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
University Hospital of Ferrara
Cona, Ferrara, 44124, 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
Related Publications (3)
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.
PMID: 25127334BACKGROUNDHilling-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.
PMID: 27726292BACKGROUNDTumscitz 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.
PMID: 33627400DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Month
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 11, 2017
First Posted
March 22, 2017
Study Start
March 11, 2017
Primary Completion
January 7, 2020
Study Completion
April 20, 2021
Last Updated
April 29, 2021
Record last verified: 2021-04