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Effects of Right Ventricular Pacemaker Lead Position Assessed by MRI

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Alfred A Kocher, MD, Medical University of Vienna.
Recruitment status was:  Enrolling by invitation
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 (Participant)
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 Alfred A Kocher, MD, Medical University of Vienna:

Primary Outcome Measures:
  • Ejection Fraction [ Time Frame: 6 month ]
    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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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