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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01798043
Other study ID # CR-12-048-CH-LV
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date January 2013
Est. completion date January 2016

Study information

Verified date July 2020
Source Abbott Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Terminated
Enrollment 29
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Cardiac MRI with pacemaker stimulation
Patient is undergoing a Cardiac MRI at enrollment and 12 months later
Cardiac MRI with and without pacemaker stimulation
Patient is undergoing a Cardiac MRI at enrollment and 12 months later

Locations

Country Name City State
Switzerland Stadtspital Triemli Zurich

Sponsors (1)

Lead Sponsor Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in LV chamber volumes. 12 months (baseline to end of study)
Secondary Change in Dyssynchrony 12 months
Secondary Change in Ejection fraction 12 months
Secondary Change in Strain rate 12 months
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