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The Pacing vs No Pacing Study - PNP Study

NCT02498639 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-07-15

No results posted yet for this study

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

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Antonio Marzocchi, MD · IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-12-31
Completion
2016-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02498639 on ClinicalTrials.gov