Aortic Valve StenosisSOFTLY-IINCT03087552
Mini-invasive Balloon Aortic Valvuloplasty
An observational study of Aortic Valve Stenosis, run by University Hospital of Ferrara at 17 sites in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Transradial balloon aortic valvuloplasty
- Type of treatment
- Surgery or procedure
- How many people
- 361 participants
- Where
- 17 sitesItaly
- Study dates
- 11 Mar 2017to 20 Apr 2021
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with severe aortic stenosis with indication to balloon aortic valvuloplasty
Who may be able to join
- severe symptomatic aortic stenosis requiring balloon aortic valvuloplasty
Who cannot join
- cardiogenic shock
- bilateral absence of radial pulse
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Italy17 sites
AOU di Ancona
Ancona
AOU di Bologna
Bologna
Ospedale Bassini
Cinisello Balsamo, Milano
University Hospital of Ferrara
Cona, Ferrara, 44124
Ospedale di Conegliano
Conegliano, Treviso
Ospedale Morgagni Pierantoni
Forlì
Ospedale Misericordia
Grosseto
Ospedale Vito Fazzi
Lecce
AOU San Luigi Gonzaga
Orbassano, Torino
Ospedale Civile Santo Spirito
Pescara
Ospedale Santa Maria delle Croci
Ravenna
Ospedale degli Infermi
Rimini
Ospedale San Giovanni di Dio e Ruggi d'Aragona
Salerno
Ospedale di Sassari
Sassari
ASL di Teramo
Teramo
Ospedale degli Infermi di Rivoli
Torino
Pia Fondazione Panico
Tricase, Lecce
About this study
Official title: Safety and Feasibility of Transradial Mini-invasive Balloon Aortic Valvuloplasty
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.
Read the 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
- Being tested
- Transradial balloon aortic valvuloplasty
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transradial balloon aortic valvuloplastyProcedure or surgery
Mini-invasive balloon aortic valvuloplasty consisting in transradial access
Transradial balloon aortic valvuloplastyProcedure or surgery
Rapid pacing using the 0.035-in. retrograde left ventricular support wire
| Study group | Role | What they receive |
|---|---|---|
| Transradial balloon aortic valvuloplasty | Consecutive patients with severe aortic stenosis and receiving as first attempt balloon aortic valvuloplasty by transradial access. Receives: Procedure: Transradial balloon aortic valvuloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular complications
Cumulative occurrence of major and minor bleeding complications according the VARC-2 classification
Measured: 1 month
Secondary outcomes (6)
Transradial balloon aortic valvuloplasty major complications
Balloon entrapment, compartment syndrome requiring surgical intervention
Measured: 1 month
Adverse events
Cumulative occurrence of death, stroke, coronary occlusion, coronary dissection, moderate-severe aortic regurgitation, severe hypotension requiring intervention, pericardiocentesis, definitive pace-maker implantation
Measured: 1 month
Major vascular complications
Cumulative occurrence of major bleeding complications according the VARC-2
Measured: 1 month
Minor vascular complications
Cumulative occurrence of minor bleeding complications according the VARC-2
Measured: 1 month
Radial artery occlusion
Cumulative occurrence of radial artery occlusion
Measured: 1 month
Radial artery occlusion
Cumulative occurrence of radial artery occlusion
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start11 Mar 2017
- Primary completion7 Jan 2020
- Study completion20 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 361 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Campo, University Hospital of Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087552
- Sponsor's protocol ID
- 18072011
- Acronym
- SOFTLY-II
- Status last verified
- Apr 2021
- First submitted
- 11 Mar 2017
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25127334Hilling-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.
PubMed 27726292Tumscitz 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.
PubMed 33627400
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Transradial Mini-invasive Balloon Aortic Valvuloplasty
- ClinicalTrials.gov ID
- NCT03087552
- Acronym / sponsor ID
- SOFTLY-II / 18072011
- Conditions
- Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- 11 Mar 2017 (actual)
- Primary completion
- 7 Jan 2020 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 22 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transradial balloon aortic valvuloplasty | – | Procedure: Transradial balloon aortic valvuloplastyConsecutive patients with severe aortic stenosis and receiving as first attempt balloon aortic valvuloplasty by transradial access. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with severe aortic stenosis with indication to balloon aortic valvuloplasty
Key inclusion criteria (1 listed)
- severe symptomatic aortic stenosis requiring balloon aortic valvuloplasty
Key exclusion criteria (2 listed)
- cardiogenic shock
- bilateral absence of radial pulse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transradial balloon aortic valvuloplastyMini-invasive balloon aortic valvuloplasty consisting in transradial access | Procedure or surgery | Transradial balloon aortic valvuloplasty |
| Transradial balloon aortic valvuloplastyRapid pacing using the 0.035-in. retrograde left ventricular support wire | Procedure or surgery | Transradial balloon aortic valvuloplasty |
Primary outcome
Vascular complications
Time frame: 1 month
Cumulative occurrence of major and minor bleeding complications according the VARC-2 classification
6 secondary outcomes
Transradial balloon aortic valvuloplasty major complications
Time frame: 1 month
Adverse events
Time frame: 1 month
Major vascular complications
Time frame: 1 month
Minor vascular complications
Time frame: 1 month
Radial artery occlusion
Time frame: 1 month
Radial artery occlusion
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Background: PubMed 25127334Tumscitz 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.
- Background: PubMed 27726292Hilling-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.
- Derived from this study: PubMed 33627400Tumscitz 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by University Hospital of Ferrara at 17 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular complications (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03087552, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.