- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01798043
Impact of Septal Vs Apical Pacing on Right and Left Ventricular Performance
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Zurich, Switzerland, 8063
- Stadtspital Triemli
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Septal RV lead with >50% pacing (B1)
Cardiac MRI with pacemaker stimulation
|
Patient is undergoing a Cardiac MRI at enrollment and 12 months later
|
Experimental: Septal RV lead with <50% pacing (B2)
Cardiac MRI with and without pacemaker stimulation
|
Patient is undergoing a Cardiac MRI at enrollment and 12 months later
|
Experimental: Apical RV lead with >50% pacing (A1)
Cardiac MRI with pacemaker stimulation
|
Patient is undergoing a Cardiac MRI at enrollment and 12 months later
|
Experimental: Apical RV lead with <50% pacing (A2)
Cardiac MRI with and without pacemaker stimulation
|
Patient is undergoing a Cardiac MRI at enrollment and 12 months later
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in LV chamber volumes.
Time Frame: 12 months (baseline to end of study)
|
12 months (baseline to end of study)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Dyssynchrony
Time Frame: 12 months
|
12 months
|
Change in Ejection fraction
Time Frame: 12 months
|
12 months
|
Change in Strain rate
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rainer Zbinden, MD, Triemli Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR-12-048-CH-LV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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