Back to resultsImpact of Septal Vs Apical Pacing on Right and Left Ventricular Performance
Primary Purpose
Heart Block, Sick Sinus Syndrome, Atrioventricular Block
Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Cardiac MRI with pacemaker stimulation
Cardiac MRI with and without pacemaker stimulation
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Block
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.
Sites / Locations
- Stadtspital Triemli
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Septal RV lead with >50% pacing (B1)
Septal RV lead with <50% pacing (B2)
Apical RV lead with >50% pacing (A1)
Apical RV lead with <50% pacing (A2)
Arm Description
Cardiac MRI with pacemaker stimulation
Cardiac MRI with and without pacemaker stimulation
Cardiac MRI with pacemaker stimulation
Cardiac MRI with and without pacemaker stimulation
Outcomes
Primary Outcome Measures
Change in LV chamber volumes.
Secondary Outcome Measures
Change in Dyssynchrony
Change in Ejection fraction
Change in Strain rate
Full Information
NCT ID
NCT01798043
First Posted
February 21, 2013
Last Updated
July 23, 2020
Sponsor
Abbott Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT01798043
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
Due to slow enrolment
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Block, Sick Sinus Syndrome, Atrioventricular Block, Ventricular Dysfunction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Septal RV lead with >50% pacing (B1)
Arm Type
Experimental
Arm Description
Cardiac MRI with pacemaker stimulation
Arm Title
Septal RV lead with <50% pacing (B2)
Arm Type
Experimental
Arm Description
Cardiac MRI with and without pacemaker stimulation
Arm Title
Apical RV lead with >50% pacing (A1)
Arm Type
Experimental
Arm Description
Cardiac MRI with pacemaker stimulation
Arm Title
Apical RV lead with <50% pacing (A2)
Arm Type
Experimental
Arm Description
Cardiac MRI with and without pacemaker stimulation
Intervention Type
Other
Intervention Name(s)
Cardiac MRI with pacemaker stimulation
Intervention Description
Patient is undergoing a Cardiac MRI at enrollment and 12 months later
Intervention Type
Other
Intervention Name(s)
Cardiac MRI with and without pacemaker stimulation
Intervention Description
Patient is undergoing a Cardiac MRI at enrollment and 12 months later
Primary Outcome Measure Information:
Title
Change in LV chamber volumes.
Time Frame
12 months (baseline to end of study)
Secondary Outcome Measure Information:
Title
Change in Dyssynchrony
Time Frame
12 months
Title
Change in Ejection fraction
Time Frame
12 months
Title
Change in Strain rate
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rainer Zbinden, MD
Organizational Affiliation
Triemli Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stadtspital Triemli
City
Zurich
ZIP/Postal Code
8063
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Impact of Septal Vs Apical Pacing on Right and Left Ventricular Performance
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