Aortic Valve StenosisPhase 4PNPNCT02498639
The Pacing vs No Pacing Study - PNP Study
A Phase 4 study testing percutaneous balloon aortic valvuloplasty in people with Aortic Valve Stenosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- percutaneous balloon aortic valvuloplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2015to Jan 2016
- Phase
- Phase 4
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- clinical presentation in cardiogenic shock at the time of BAV.
- clinical presentation in acute pulmonary edema not previously stabilized by medical therapy.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Institute of Cardiology, Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Francesco Saia, MD, 00390512144475, francescosaia@hotmail.com
Gianni Dall'Ara, MD, 00390512144475, dallara.gianni@gmail.com
About this study
Official title: Comparison of Safety and Efficacy of Percutaneous Balloon Aortic Valvuloplasty Performed With or Without Rapid Ventricular Pacing - The Pacing vs No Pacing Study (PNP Study)
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.
Read the 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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- percutaneous balloon aortic valvuloplasty
- Keywords
- balloon aortic valvuloplasty, rapid ventricular pacing, outcome
- 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.
percutaneous balloon aortic valvuloplastyProcedure or surgery
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:
- Reduction of the mean aortic gradient ≥50%.
- Aortic pressure drop during the inflations, indicative of valve orifice sealing.
- Intraprocedural complication.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: percutaneous balloon aortic valvuloplasty |
| 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. Receives: Procedure: percutaneous balloon aortic valvuloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 30-day
Secondary outcomes (12)
Trans-aortic gradient reduction ≥ 50% measured with echocardiography from baseline to post BAV (analysis per treatment).
Echocardiography performed 30 minutes after the procedure.
Measured: Post-procedural, on average 30 minutes after the procedure.
Trans-aortic gradient reduction from 30 to 49%
Echocardiography performed 30 minutes after the procedure.
Measured: Post-procedural, on average 30 minutes after the procedure.
Haemodynamic trans-aortic gradient reduction ≥ 50%
Measured: Just after last balloon inflation, on average 3 minutes after BAV
Haemodynamic trans-aortic gradient reduction from 30 to 49%
Measured: Just after last balloon inflation, on average 3 minutes after BAV
Overall mortality
Measured: 30-day
Cardiovascular mortality
Measured: 30-day
Ictus incidence
Measured: 30-day
Acute myocardial infarction
Measured: 30-day
Acute severe aortic insufficiency
Measured: Just after last balloon inflation, on average few seconds after BAV
Major bleeding (BARC ≥3)
Measured: 30-day
New cardiovascular hospital admission
Measured: 30-day
Evaluation of variations of the aortic valve area, and the maximum and averageaortic gradient by echocardiography from pre to post procedure
Measured: Post-procedural, on average 30 minutes after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Antonio Marzocchi, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Antonio Marzocchi, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498639
- Sponsor's protocol ID
- CE41/2015/O/Sper
- Acronym
- PNP
- Status last verified
- Jul 2015
- First submitted
- 10 Jul 2015
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Safety and Efficacy of Percutaneous Balloon Aortic Valvuloplasty Performed With or Without Rapid Ventricular Pacing - The Pacing vs No Pacing Study (PNP Study)
- ClinicalTrials.gov ID
- NCT02498639
- Acronym / sponsor ID
- PNP / CE41/2015/O/Sper
- Conditions
- Aortic Valve Stenosis
- Keywords
- balloon aortic valvuloplasty, rapid ventricular pacing, outcome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 15 Jul 2015 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAV without pacing | Active comparator | Procedure: percutaneous balloon aortic valvuloplastyPatients 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 | Procedure: percutaneous balloon aortic valvuloplastyPatients 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- clinical presentation in cardiogenic shock at the time of BAV.
- clinical presentation in acute pulmonary edema not previously stabilized by medical therapy.
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 |
|---|---|---|
| percutaneous balloon aortic valvuloplastyPercutaneous 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. | Procedure or surgery | BAV with pacing, BAV without pacing |
Primary outcome
Efficacy endpoint: trans-aortic gradient reduction ≥ 50% measured with echocardiography from baseline to post BAV (analysis intention to treat).
Time frame: 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)
Time frame: 30-day
12 secondary outcomes
Trans-aortic gradient reduction ≥ 50% measured with echocardiography from baseline to post BAV (analysis per treatment).
Time frame: Post-procedural, on average 30 minutes after the procedure.
Trans-aortic gradient reduction from 30 to 49%
Time frame: Post-procedural, on average 30 minutes after the procedure.
Haemodynamic trans-aortic gradient reduction ≥ 50%
Time frame: Just after last balloon inflation, on average 3 minutes after BAV
Haemodynamic trans-aortic gradient reduction from 30 to 49%
Time frame: Just after last balloon inflation, on average 3 minutes after BAV
Overall mortality
Time frame: 30-day
Cardiovascular mortality
Time frame: 30-day
Ictus incidence
Time frame: 30-day
Acute myocardial infarction
Time frame: 30-day
Acute severe aortic insufficiency
Time frame: Just after last balloon inflation, on average few seconds after BAV
Major bleeding (BARC ≥3)
Time frame: 30-day
New cardiovascular hospital admission
Time frame: 30-day
Evaluation of variations of the aortic valve area, and the maximum and averageaortic gradient by echocardiography from pre to post procedure
Time frame: Post-procedural, on average 30 minutes after the procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
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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.
Antonio Marzocchi, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing percutaneous balloon aortic valvuloplasty in people with Aortic Valve Stenosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site 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 4 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: status not confirmed, as of the sponsor's last update on 15 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Marzocchi, MD (00390512144475, antonio.marzocchi@tin.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy endpoint: trans-aortic gradient reduction ≥ 50% measured with echocardiography from baseline to post BAV (analysis intention to treat). (time frame: Post-procedural, on average 30 minutes after the procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2015.