NCT01535404

Brief 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%).

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
2 countries

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 17, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 13, 2016

Status Verified

October 1, 2014

Enrollment Period

4.3 years

First QC Date

February 10, 2012

Last Update Submit

May 11, 2016

Conditions

Bradyarrhythmia

Outcome Measures

Primary Outcomes (1)

  • Reduction in LVEF

    baseline to one year

Secondary Outcomes (8)

  • Change in left ventricular end-systolic and end-diastolic volumes

    one year

  • Dyssynchrony evaluation during RV and LV pacing

    one year

  • Change in tricuspid regurgitation severity, if any

    one year

  • Change in mitral regurgitation severity, if any

    one year

  • Incidence of device-related complications

    one year

  • +3 more secondary outcomes

Study Arms (2)

Right ventricular apex pacing

ACTIVE COMPARATOR
Device: Implantation procedure for a St-Jude Medical pacemaker system with right ventricular apex pacing

Left ventricular apex pacing

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

Interventions

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

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

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

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

Left ventricular apex pacing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Requirement for ventricular pacing according to current guidelines (including chronic atrial fibrillation)
  • Anticipated \>=50% daily ventricular pacing
  • LVEF \>=45% as evaluated by 2D-echocardiography, 3D-echocardiography, magnetic resonance imaging or by radionuclide/contrast ventriculography
  • Minimum age of 18 years, and at least 1 year life expectancy

You may not qualify if:

  • Prior tricuspid valve replacement (annuloplasty is permitted)
  • Intrinsic rhythm \< 30bpm
  • Patients with permanent atrial fibrillation who undergo ablation of the atrioventricular node.
  • Echocardiographic window of insufficient quality for measuring LVEF
  • Life expectancy of \< 1year
  • Pregnancy (women of childbearing potential will undergo pregnancy testing)
  • Unable of unwilling to sign a patient informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Cardiovascular Research Institute, University of Maastricht

Maastricht, 6229, Netherlands

Location

University Hospital of Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

University Hospital Geneva

Geneva, Canton of Geneva, 1211, Switzerland

Location

Kantonsspital Luzern

Lucerne, Canton of Lucerne, 6000, Switzerland

Location

Kantonsspital St-Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

Cardiocentro Ticino (Lugano)

Lugano, Canton Ticino, 6900, Switzerland

Location

MeSH Terms

Conditions

Bradycardia

Interventions

Mutagenesis, Insertional

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Protein EngineeringGenetic EngineeringGenetic TechniquesInvestigative TechniquesMutationGenetic VariationGenetic PhenomenaMutagenesis

Study Officials

  • Haran Burri, Assoc. Prof.

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

  • Angelo Auricchio, Prof.

    Fondazione Cardiocentro Ticino (Lugano)

    PRINCIPAL INVESTIGATOR

  • Christian Sticherling, Prof.

    University Hospital of Basel

    STUDY CHAIR

  • Paul Erne, Prof.

    Luzerner Kantonsspital

    STUDY CHAIR

  • Peter Ammann, PD Dr.

    Cantonal Hospital of St. Gallen

    STUDY CHAIR

  • Frits Prinzen, Dr.

    Cardiovascular Research Institute, University of Maastricht

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

February 10, 2012

First Posted

February 17, 2012

Study Start

January 1, 2012

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 13, 2016

Record last verified: 2014-10

Locations

NL(1)CH(5)