Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2015-04-30
2016-01-31
Brief Summary
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Detailed Description
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It is a pilot study with the objective to enroll 100 consecutive patients matching inclusion and exclusion criteria who are randomized 1:1 in two arms: in the first patients undergo procedure of BAV without rapid pacing, in the second BAV with rapid ventricular pacing able to help in balloon stabilization during inflations.
Efficacy will be studied analysing changes in transvalvular gradient from baseline to post-BAV. Safety outcomes will be collected both at discharge and at 30-day. Other procedural data will be object of direct comparison.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BAV without pacing
Patients undergo percutaneous balloon aortic valvuloplasty (BAV) without previous insertion of a temporary pacemaker lead in the right ventricle. Stabilization of the balloon during inflation is done without rapid pacing.
percutaneous balloon aortic valvuloplasty
Percutaneous BAV is performed according to the standard retrograde technique. The measurement of the trans-aortic gradient is given by two catheters placed one in the left ventricle, the other in ascending aorta. An extra stiff wire is placed in the left ventricular cavity. A balloon (size fitting the valve annulus) is inserted over the wire and a series of three inflations is performed at nominal pressure.
The procedure terminates in case of:
1. Reduction of the mean aortic gradient ≥50%.
2. Aortic pressure drop during the inflations, indicative of valve orifice sealing.
3. Intraprocedural complication.
4. Poor compliance of the patient. If none is met, the balloon is changed with a bigger one and a new series of three inflations performed. Aortic gradient is finally recorded.
BAV with pacing
Patients undergo percutaneous balloon aortic valvuloplasty (BAV) after previous insertion of a temporary pacemaker lead in the right ventricle. Stabilization of the balloon during inflation is done under rapid pacing.
percutaneous balloon aortic valvuloplasty
Percutaneous BAV is performed according to the standard retrograde technique. The measurement of the trans-aortic gradient is given by two catheters placed one in the left ventricle, the other in ascending aorta. An extra stiff wire is placed in the left ventricular cavity. A balloon (size fitting the valve annulus) is inserted over the wire and a series of three inflations is performed at nominal pressure.
The procedure terminates in case of:
1. Reduction of the mean aortic gradient ≥50%.
2. Aortic pressure drop during the inflations, indicative of valve orifice sealing.
3. Intraprocedural complication.
4. Poor compliance of the patient. If none is met, the balloon is changed with a bigger one and a new series of three inflations performed. Aortic gradient is finally recorded.
Interventions
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percutaneous balloon aortic valvuloplasty
Percutaneous BAV is performed according to the standard retrograde technique. The measurement of the trans-aortic gradient is given by two catheters placed one in the left ventricle, the other in ascending aorta. An extra stiff wire is placed in the left ventricular cavity. A balloon (size fitting the valve annulus) is inserted over the wire and a series of three inflations is performed at nominal pressure.
The procedure terminates in case of:
1. Reduction of the mean aortic gradient ≥50%.
2. Aortic pressure drop during the inflations, indicative of valve orifice sealing.
3. Intraprocedural complication.
4. Poor compliance of the patient. If none is met, the balloon is changed with a bigger one and a new series of three inflations performed. Aortic gradient is finally recorded.
Eligibility Criteria
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Inclusion Criteria
* no immediate indication to aortic valve replacement (AVR).
* indication to balloon aortic valvuloplasty (BAV).
* written expression of informed consent.
Exclusion Criteria
* clinical presentation in acute pulmonary edema not previously stabilized by medical therapy.
70 Years
ALL
No
Sponsors
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Responsible Party
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Dr. Antonio Marzocchi
MD
Principal Investigators
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Antonio Marzocchi, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Locations
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Institute of Cardiology, Azienda Ospedaliero-Universitaria di Bologna
Bologna, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CE41/2015/O/Sper
Identifier Type: -
Identifier Source: org_study_id
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