Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01798043
Recruitment Status : Terminated (Due to slow enrolment)
First Posted : February 25, 2013
Last Update Posted : July 24, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE February 21, 2013
First Posted Date  ICMJE February 25, 2013
Last Update Posted Date July 24, 2020
Study Start Date  ICMJE January 2013
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2013)
Change in LV chamber volumes. [ Time Frame: 12 months (baseline to end of study) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2013)
  • Change in Dyssynchrony [ Time Frame: 12 months ]
  • Change in Ejection fraction [ Time Frame: 12 months ]
  • Change in Strain rate [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Septal Vs Apical Pacing on Right and Left Ventricular Performance
Official Title  ICMJE Impact of Septal Vs Apical Pacing on Right and Left Ventricular Performance
Brief Summary 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).
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Heart Block
  • Sick Sinus Syndrome
  • Atrioventricular Block
  • Ventricular Dysfunction
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 23, 2020)
29
Original Estimated Enrollment  ICMJE
 (submitted: February 21, 2013)
50
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01798043
Other Study ID Numbers  ICMJE CR-12-048-CH-LV
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abbott Medical Devices
Study Sponsor  ICMJE Abbott Medical Devices
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rainer Zbinden, MD Triemli Hospital
PRS Account Abbott Medical Devices
Verification Date July 2020

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