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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAV without pacing | Active Comparator | 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. |
|
| BAV with pacing | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| percutaneous balloon aortic valvuloplasty | Procedure | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy endpoint: trans-aortic gradient reduction ≥ 50% measured with echocardiography from baseline to post BAV (analysis intention to treat). | Echocardiography performed 30 minutes after the procedure. | Post-procedural, on average 30 minutes after the procedure. |
| Composite safety endpoint: death, myocardial infarction, stroke, acute aortic valve insufficiency, major bleeding (BARC classification ≥3) | 30-day |
| Measure | Description | Time Frame |
|---|---|---|
| Trans-aortic gradient reduction ≥ 50% measured with echocardiography from baseline to post BAV (analysis per treatment). | Echocardiography performed 30 minutes after the procedure. | Post-procedural, on average 30 minutes after the procedure. |
| Trans-aortic gradient reduction from 30 to 49% |
| Measure | Description | 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 | |
| Acute kidney injury |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Marzocchi, MD | Contact | 00390512144475 | antonio.marzocchi@tin.it | |
| Francesco Saia, MD | Contact | 00390512144475 | francescosaia@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Antonio Marzocchi, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Cardiology, Azienda Ospedaliero-Universitaria di Bologna | Recruiting | Bologna | 40138 | Italy |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
Echocardiography performed 30 minutes after the procedure. |
| Post-procedural, on average 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 |
| Ictus incidence | 30-day |
| Acute myocardial infarction | 30-day |
| Acute severe aortic insufficiency | Just after last balloon inflation, on average few seconds after BAV |
| 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. |
| at hospital discharge, on average 3 days after BAV |
| Hospitalization duration | at hospital discharge, on average 3 days after BAV |
| D014694 |
| Ventricular Outflow Obstruction |