Effects of Right Ventricular Pacemaker Lead Position Assessed by MRI

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Alfred A Kocher, MD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01682239
First received: September 6, 2012
Last updated: September 7, 2012
Last verified: September 2012
  Purpose

Chronic right ventricular apical pacing has been associated with negative hemodynamic effects. Clinical outcome of right ventricular pacing can be influenced by multiple factors. An important factor seems to be optimal lead positioning. Data regarding left ventricular function impaired by lead positioning is insufficient. The aim of the present study therefore is to compare right ventricular apical pacing (RVAP) with right ventricular septal pacing (RVSP). Outcome measurements are echocardiographic features, magnetic resonance imaging and clinical outcome.


Condition Intervention
Late Complication From Cardiac Pacemaker Implantation
Other: RVAP
Other: RVSP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Effects of Different Right Ventricular Lead Positioning on Cardiac Contraction Measured by Cardiac MRI: a Pilot Trial

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Ejection Fraction [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    As primary endpoint the difference of ventricular function in both groups will be taken. Therefore the Ejection Fraction is measured in cardiac MRI and Echocardiography. There may be a different development of contraction, whether the lead is placed in the ventricular apex or the ventricular septum.


Estimated Enrollment: 24
Study Start Date: September 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RVAP lead

Pacemaker lead implantation:

Pacemaker leads will be placed in specific predefined RA and RV sites according to randomization. In this arm pacemaker leads will be placed in the RV apex. The successful lead positioning at its target location will be verified by surface ECG and by fluoroscopy.

Other: RVAP
In this arm pacemaker leads will be placed in the RV apex.
Experimental: RVSP arm

Pacemaker lead implantation:

Pacemaker leads will be placed in specific predefined RA and RV sites according to randomization. In this arm pacemaker leads will be placed in the RV septum. The successful lead positioning at its target location will be verified by surface ECG and by fluoroscopy.

Other: RVSP
In this arm pacemaker leads will be placed in the RV septum.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • patients with dysrhythmia requiring dual-chamber pacemaker implantation
  • planed MRI-pacemaker implantation (Accent MRI System,St. Jude Medical)
  • age between 18-90 years
  • no absolute pacemaker dependence
  • no present heart failure or any significant coronary heart disease (exclusion by anamnesis and echocardiography - LVH <15mm, LV EF>50%)
  • no previous myocardial infarction or significant coronary artery disease
  • life expectancy > 1 year
  • patients willing to participate in follow-up

Exclusion criteria:

  • Contraindications for MRI (Brain aneurysm clips, artificial heart valves, artificial joints, vascular stents)
  • Any contraindication for surgery
  • Absolute pacemaker dependence
  • Claustrophobia
  • GFR<30ml/min/1,73m2
  • Allergy to contrast agent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682239

Locations
Austria
Department of Cardiac Surgery, MUV
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Alfred Kocher, MD Department of Cardiac Surgery