Impact of Septal Vs Apical Pacing on Right and Left Ventricular Performance

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01798043
First received: February 21, 2013
Last updated: January 6, 2015
Last verified: January 2015

February 21, 2013
January 6, 2015
January 2013
June 2015   (final data collection date for primary outcome measure)
Change in LV chamber volumes. [ Time Frame: 12 months (baseline to end of study) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01798043 on ClinicalTrials.gov Archive Site
  • Change in Dyssynchrony [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in Ejection fraction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in Strain rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Impact of Septal Vs Apical Pacing on Right and Left Ventricular Performance
Impact of Septal Vs Apical Pacing on Right and Left Ventricular Performance

The study aims to use cardiac MRI scans and analysis techniques to evaluate differences in cardiac function after 12 months of pacing in patients with pacing leads placed in different positions within the right ventricle (apically or septally).

Prolonged pacing from the right ventricular (RV) Apex has been shown to be associated with progressive left ventricular (LV) dysfunction. This has led to an interest in alternative right ventricular pacing sites. Only very few studies investigated the effect of alternative right ventricular pacing sites using three dimensional imaging. Using cardiac MRI volumetric left- and right ventricular analysis and three-dimensional reconstruction is more accurate compared to trans-thoracic echocardiogram. St. Jude Medical has developed a MRI conditional pacemaker system enabling for the first time to investigate alternative pacing sites using cardiac MRI.

Patients already implanted with an MRI conditional pacemaker system from St. Jude Medical will be enrolled in that study and subdivided into 4 groups (right ventricular pacing lead positioned apically or septally subdivided in patients paced for <50% of time or 50% or more). All patients will undergo cardiac MRI at enrollment and again 12 months later. Patients paced <50% of the time will undergo cardiac MRI with and without pacemaker stimulation at both visits.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Heart Block
  • Sick Sinus Syndrome
  • Atrioventricular Block
  • Ventricular Dysfunction
  • Other: Cardiac MRI with pacemaker stimulation
    Patient is undergoing a Cardiac MRI at enrollment and 12 months later
  • Other: Cardiac MRI with and without pacemaker stimulation
    Patient is undergoing a Cardiac MRI at enrollment and 12 months later
  • Experimental: Septal RV lead with >50% pacing (B1)
    Cardiac MRI with pacemaker stimulation
    Intervention: Other: Cardiac MRI with pacemaker stimulation
  • Experimental: Septal RV lead with <50% pacing (B2)
    Cardiac MRI with and without pacemaker stimulation
    Intervention: Other: Cardiac MRI with and without pacemaker stimulation
  • Experimental: Apical RV lead with >50% pacing (A1)
    Cardiac MRI with pacemaker stimulation
    Intervention: Other: Cardiac MRI with pacemaker stimulation
  • Experimental: Apical RV lead with <50% pacing (A2)
    Cardiac MRI with and without pacemaker stimulation
    Intervention: Other: Cardiac MRI with and without pacemaker stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
June 2015
June 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have been implanted with an Accent MRI pacemaker and Tendril MRI leads.
  • Have an RV lead implanted apically (group A) or septally (Group B)
  • Are RV paced for <50% of the time (groups A2 and B2)
  • Are RV paced for > 50% of the time (Groups A1 and B1)
  • Are ≥ 18 years of age.
  • Are able to provide written informed consent.
  • Are willing and able to comply with the prescribed follow-up tests and schedule of evaluations.

Exclusion Criteria:

  • Have permanent atrial fibrillation with preserved intrinsic conduction
  • Have a non-MRI compatible device or material implant (e.g., intracranial aneurysm clip, non-MRI compatible devices or material, metals or alloys, etc.).
  • Have a lead extender, plug or adaptor.
  • Do not have an RV lead implanted apically or septally.
  • Are eligible for groups A1 or B1 but appropriate group already has 20 patients enrolled.
  • Are eligible for groups A2 or B2 but appropriate group already has 5 patients enrolled
  • Are currently participating in another device or drug investigation which includes an active treatment arm.
  • Are pregnant or planning to become pregnant during the duration of the study.
  • Have a life expectancy of less than 12 months from Screening due to any life-threatening condition.
  • Are contraindicated for an MRI scan due to any other reason.
Both
18 Years and older
No
Contact: Heiko Zerlik +41 44 444 24 11 hzerlik@sjm.com
Switzerland
 
NCT01798043
CR-12-048-CH-LV
No
St. Jude Medical
St. Jude Medical
Not Provided
Principal Investigator: Rainer Zbinden, MD Triemli Hospital
St. Jude Medical
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP