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Mini-invasive Balloon Aortic Valvuloplasty (SOFTLY-II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03087552
Recruitment Status : Recruiting
First Posted : March 22, 2017
Last Update Posted : August 29, 2018
Information provided by (Responsible Party):
Gianluca Campo, 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.

Condition or disease Intervention/treatment
Aortic Valve Stenosis Procedure: Transradial balloon aortic valvuloplasty

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Safety and Feasibility of Transradial Mini-invasive Balloon Aortic Valvuloplasty
Actual Study Start Date : March 11, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Transradial balloon aortic valvuloplasty
Consecutive patients with severe aortic stenosis and receiving as first attempt balloon aortic valvuloplasty by transradial access.
Procedure: Transradial balloon aortic valvuloplasty
Mini-invasive balloon aortic valvuloplasty consisting in transradial access

Procedure: Transradial balloon aortic valvuloplasty
Rapid pacing using the 0.035-in. retrograde left ventricular support wire

Primary Outcome Measures :
  1. Vascular complications [ Time Frame: 1 month ]
    Cumulative occurrence of major and minor bleeding complications according the VARC-2 classification

Secondary Outcome Measures :
  1. Transradial balloon aortic valvuloplasty major complications [ Time Frame: 1 month ]
    Balloon entrapment, compartment syndrome requiring surgical intervention

  2. Adverse events [ Time Frame: 1 month ]
    Cumulative occurrence of death, stroke, coronary occlusion, coronary dissection, moderate-severe aortic regurgitation, severe hypotension requiring intervention, pericardiocentesis, definitive pace-maker implantation

  3. Major vascular complications [ Time Frame: 1 month ]
    Cumulative occurrence of major bleeding complications according the VARC-2

  4. Minor vascular complications [ Time Frame: 1 month ]
    Cumulative occurrence of minor bleeding complications according the VARC-2

  5. Radial artery occlusion [ Time Frame: 1 month ]
    Cumulative occurrence of radial artery occlusion

  6. Radial artery occlusion [ Time Frame: 24 hours ]
    Cumulative occurrence of radial artery occlusion

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with severe aortic stenosis with indication to balloon aortic valvuloplasty

Inclusion Criteria:

  • severe symptomatic aortic stenosis requiring balloon aortic valvuloplasty

Exclusion Criteria:

  • cardiogenic shock
  • bilateral absence of radial pulse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03087552

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Contact: Veronica Lodolini, BSc 0532236450 ext +39
Contact: Elisa Mosele, BSc 0532237227 ext +39

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University Hospital of Ferrara Recruiting
Cona, Ferrara, Italy, 44124
Contact: Matteo Tebaldi, MD    +390532236450   
Contact: Simone Biscaglia, MD    +390532236450   
Principal Investigator: Gianluca Campo, MD         
Principal Investigator: Matteo Tebaldi, MD         
Sub-Investigator: Simone Biscaglia, MD         
Ospedale Bassini Recruiting
Cinisello Balsamo, Milano, Italy
Contact: Simona Pierini         
AOU San Luigi Gonzaga Recruiting
Orbassano, Torino, Italy
Contact: Enrico Cerrato         
Ospedale di Conegliano Recruiting
Conegliano, Treviso, Italy
Contact: Gerlando Preti         
AOU di Ancona Recruiting
Ancona, Italy
Contact: Tommaso Piva         
AOU di Bologna Recruiting
Bologna, Italy
Contact: Francesco Saia         
Ospedale Morgagni Pierantoni Recruiting
Forlì, Italy
Contact: Fabio Tarantino         
Ospedale Santa Maria delle Croci Recruiting
Ravenna, Italy
Contact: Marco Balducelli         
Ospedale degli Infermi Recruiting
Rimini, Italy
Contact: Andrea Santarelli         
Ospedale San Giovanni di Dio e Ruggi d'Aragona Recruiting
Salerno, Italy
Contact: Tiziana Attisano         
Ospedale di Sassari Recruiting
Sassari, Italy
Contact: Guido Parodi         
ASL di Teramo Recruiting
Teramo, Italy
Contact: Gianluca Tomassoni         
Ospedale degli Infermi di Rivoli Recruiting
Torino, Italy
Contact: Cristina Rolfo         
Sponsors and Collaborators
University Hospital of Ferrara

Additional Information:

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Responsible Party: Gianluca Campo, Associate Professor, University Hospital of Ferrara Identifier: NCT03087552     History of Changes
Other Study ID Numbers: 18072011
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction