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Transcatheter Aortic Valve Implantation Without Predilation

NCT01539746 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2022-11-07

No results posted yet for this study

Summary

The purpose of this study is to demonstrate that the avoidance of balloon valvuloplasty for predilation of the native aortic valve is associated with a reduction of the composite primary endpoint in TAVI patients with severely impaired left-ventricular ejection fraction (LVEF ≤35%).

Conditions

  • Aortic Stenosis
  • Left Ventricular Function Systolic Dysfunction
  • High-risk Patients
  • Transcatheter Aortic Valve Implantation

Interventions

PROCEDURE

TAVI without BAV

Avoidance of balloon valvuloplasty (BAV) of the native aortic valve before valve deployment

PROCEDURE

TAVI standard procedure

TAVI standard procedure including BAV before valve deployment

Sponsors & Collaborators

  • University Hospital, Bonn

    lead OTHER

Principal Investigators

  • Georg Nickenig, MD · Department of Medicine II, University Hospital Bonn

  • Jan-Malte Sinning, MD · Department of Medicine II, University Hospital Bonn

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-09
Primary Completion
2019-11-22
Completion
2019-11-22

Countries

  • Germany

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 NCT01539746 on ClinicalTrials.gov