Impact of Septal Vs Apical Pacing on Right and Left Ventricular Performance
Verified November 2013 by St. Jude Medical
Information provided by (Responsible Party):
St. Jude Medical
First received: February 21, 2013
Last updated: November 14, 2013
Last verified: November 2013
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).
Sick Sinus Syndrome
||Observational Model: Cohort
Time Perspective: Prospective
||Impact of Septal Vs Apical Pacing on Right and Left Ventricular Performance
Primary Outcome Measures:
- Change in LV chamber volumes. [ Time Frame: 12 months (baseline to end of study) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2015 (Final data collection date for primary outcome measure)
Septal RV lead with >50% pacing
Septal RV lead with <50% pacing
Apical RV lead with >50% pacing
Apical RV lead with <50% pacing
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients previously implanted with a pacemaker system not contraindicated for use in an MRI scanner.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01798043
St. Jude Medical
||Rainer Zbinden, MD
No publications provided
||St. Jude Medical
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 21, 2013
||November 14, 2013
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 27, 2014
Sick Sinus Syndrome