Right Versus Left Apical Transvenous Pacing for Patients With Preserved Left Ventricular Systolic Function Study

NCT01535404 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2016-05-13

No results posted yet for this study

Summary

The purpose of this study is to compare chronic (1-year) effects on left ventricular ejection fraction resulting from transvenous pacing of the right ventricular apex (RVA) versus the left ventricular apex (LVA) in patients with preserved or mildly reduced left ventricular systolic function (\>= 45%).

Conditions

  • Bradyarrhythmia

Interventions

DEVICE

Implantation procedure for a St-Jude Medical pacemaker system with right ventricular apex pacing

Implantation procedure for a St-Jude Medical pacemaker system with a transvenous ventricular and if applicable a right atrial lead

DEVICE

Implantation procedure for a St-Jude Medical pacemaker system with left ventricular apex pacing

Implantation procedure for a St-Jude Medical pacemaker system with a transvenous left ventricular (coronary sinus) and if applicable a right atrial lead

Sponsors & Collaborators

  • Abbott Medical Devices

    collaborator INDUSTRY
  • Haran Burri, MD

    lead OTHER

Principal Investigators

  • Haran Burri, Assoc. Prof. · University Hospital, Geneva

  • Angelo Auricchio, Prof. · Fondazione Cardiocentro Ticino (Lugano)

  • Christian Sticherling, Prof. · University Hospital of Basel

  • Paul Erne, Prof. · Luzerner Kantonsspital

  • Peter Ammann, PD Dr. · Cantonal Hospital of St. Gallen

  • Frits Prinzen, Dr. · Cardiovascular Research Institute, University of Maastricht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • Netherlands
  • Switzerland

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 NCT01535404 on ClinicalTrials.gov