Aortic Valve Stenosis
Conditions
Keywords
balloon aortic valvuloplasty, rapid ventricular pacing, outcome
Brief summary
Pilot interventional study, without drug, randomized 1: 1, open-label comparison of efficacy and safety between the technique of percutaneous balloon aortic valvuloplasty without rapid ventricular pacing vs valvuloplasty during rapid ventricular pacing (using a temporary pacemaker device with CE mark). It is expected to enroll 100 patients. Randomization is done through a dedicated computer program.
Detailed description
The aim is to compare, in terms of procedural success and safety, the procedure of percutaneous balloon aortic valvuloplasty (BAV) without rapid ventricular pacing with the same procedure carried out with the aid of rapid ventricular pacing. 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.
Interventions
PROCEDUREpercutaneous 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.
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosis of severe symptomatic aortic valve stenosis. * no immediate indication to aortic valve replacement (AVR). * indication to balloon aortic valvuloplasty (BAV). * written expression of informed consent.
Exclusion criteria
* clinical presentation in cardiogenic shock at the time of BAV. * clinical presentation in acute pulmonary edema not previously stabilized by medical therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy endpoint: trans-aortic gradient reduction ≥ 50% measured with echocardiography from baseline to post BAV (analysis intention to treat). | Post-procedural, on average 30 minutes after the procedure. | Echocardiography performed 30 minutes after the procedure. |
| Composite safety endpoint: death, myocardial infarction, stroke, acute aortic valve insufficiency, major bleeding (BARC classification ≥3) | 30-day | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Trans-aortic gradient reduction from 30 to 49% | Post-procedural, on average 30 minutes after the procedure. | Echocardiography performed 30 minutes after the procedure. |
| Haemodynamic trans-aortic gradient reduction ≥ 50% | Just after last balloon inflation, on average 3 minutes after BAV | — |
| Haemodynamic trans-aortic gradient reduction from 30 to 49% | Just after last balloon inflation, on average 3 minutes after BAV | — |
| Overall mortality | 30-day | — |
| Cardiovascular mortality | 30-day | — |
| Trans-aortic gradient reduction ≥ 50% measured with echocardiography from baseline to post BAV (analysis per treatment). | Post-procedural, on average 30 minutes after the procedure. | Echocardiography performed 30 minutes after the procedure. |
| Major bleeding (BARC ≥3) | 30-day | — |
| New cardiovascular hospital admission | 30-day | — |
| Evaluation of variations of the aortic valve area, and the maximum and averageaortic gradient by echocardiography from pre to post procedure | Post-procedural, on average 30 minutes after the procedure. | — |
| Ictus incidence | 30-day | — |
| Acute myocardial infarction | 30-day | — |
| Acute severe aortic insufficiency | Just after last balloon inflation, on average few seconds after BAV | — |
Other
| Measure | Time frame |
|---|---|
| Compare change in transvalvular gradient pre and post BAV measured between the left ventricle and aorta (LV-Ao) vs gradient measured between the left ventricle and femoral artery (LV-periphery). | Just after last balloon inflation, on average 3 minutes after BAV |
| Hospitalization duration | at hospital discharge, on average 3 days after BAV |
| Acute kidney injury | at hospital discharge, on average 3 days after BAV |
Countries
Italy
Contacts
Primary ContactAntonio Marzocchi, MD
Backup ContactFrancesco Saia, MD
Outcome results
None listed