Status:
TERMINATED
Impact of Septal Vs Apical Pacing on Right and Left Ventricular Performance
Lead Sponsor:
Abbott Medical Devices
Conditions:
Heart Block
Sick Sinus Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01798043
Start Date
January 1 2013
End Date
January 1 2016
Last Update
July 24 2020
Active Locations (1)
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1
Stadtspital Triemli
Zurich, Switzerland, 8063