Suspended

Impact of Septal Vs Apical Pacing on Right and Left Ventricular Performance

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What is being tested

Cardiac MRI with pacemaker stimulation

+ Cardiac MRI with and without pacemaker stimulation

+ Cardiac MRI with pacemaker stimulation

Other
Who is being recruted

Cardiac Conduction System Disease+8

+ Arrhythmias, Cardiac

+ Arrhythmia, Sinus

Over 18 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: January 2013
See protocol details

Summary

Principal SponsorAbbott Medical Devices
Last updated: July 24, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

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.

Principal SponsorAbbott Medical Devices
Last updated: July 24, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

29 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiac Conduction System DiseaseArrhythmias, CardiacArrhythmia, SinusCardiovascular DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart BlockSick Sinus SyndromeVentricular DysfunctionAtrioventricular Block

Criteria

7 inclusion criteria required to participate
Are >= 18 years of age

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 able to provide written informed consent

Show More Criteria

10 exclusion criteria prevent from participating
Are contraindicated for an MRI scan due to any other reason

Are currently participating in another device or drug investigation which includes an active treatment arm

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Cardiac MRI with pacemaker stimulation

Group II

Experimental
Cardiac MRI with and without pacemaker stimulation

Group III

Experimental
Cardiac MRI with pacemaker stimulation

Group IV

Experimental
Cardiac MRI with and without pacemaker stimulation

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Stadtspital Triemli

Zurich, SwitzerlandOpen Stadtspital Triemli in Google Maps
SuspendedOne Study Center