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

Launched by ABBOTT MEDICAL DEVICES · Feb 21, 2013

Keywords

ClinConnect Summary

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...

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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.