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

• ClinicalTrials.gov Identifier: NCT01798043
• Recruitment Status: Terminated
• First Posted: February 25, 2013
• Last Update Posted: July 24, 2020
• Sponsor: Abbott Medical Devices
• Information provided by (Responsible Party): Abbott Medical Devices

Tracking Information

• First Submitted Date: February 21, 2013
• First Posted Date: February 25, 2013
• Last Update Posted Date: July 24, 2020
• Study Start Date: January 2013
• Actual Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 21, 2013): Change in LV chamber volumes. [ Time Frame: 12 months (baseline to end of study) ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Impact of Septal Vs Apical Pacing on Right and Left Ventricular Performance
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic

Condition

• Heart Block
• Sick Sinus Syndrome
• Atrioventricular Block
• Ventricular Dysfunction

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: July 23, 2020): 29
• Original Estimated Enrollment (submitted: February 21, 2013): 50
• Actual Study Completion Date: January 2016
• Actual Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT01798043
• Other Study ID Numbers: CR-12-048-CH-LV
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Abbott Medical Devices
• Study Sponsor: Abbott Medical Devices
• Collaborators: Not Provided

Investigators

• Principal Investigator: Rainer Zbinden, MD; Triemli Hospital

• PRS Account: Abbott Medical Devices
• Verification Date: July 2020