The Pacing vs No Pacing Study - PNP Study

NCT02498639 | Unknown Phase 4

• 1 other identifier: CE41/2015/O/Sper
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis

Keywords

balloon aortic valvuloplasty; rapid ventricular pacing; outcome

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (12)

• 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.

• Trans-aortic gradient reduction from 30 to 49%

  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

Other Outcomes (3)

• 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

  at hospital discharge, on average 3 days after BAV

• Hospitalization duration

  at hospital discharge, on average 3 days after BAV

Study Arms (2)

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.

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.

Procedure: percutaneous balloon aortic valvuloplasty

Interventions

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: 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; BAV without pacing

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• clinical presentation in cardiogenic shock at the time of BAV.
• clinical presentation in acute pulmonary edema not previously stabilized by medical therapy.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Institute of Cardiology, Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Antonio Marzocchi, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Marzocchi, MD

CONTACT

00390512144475; antonio.marzocchi@tin.it

Francesco Saia, MD

CONTACT

00390512144475; francescosaia@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 10, 2015
• First Posted: July 15, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: July 15, 2015

Record last verified: 2015-07

Locations

IT (1)