Clinical Trials Directory

Trials / Completed

CompletedNCT01426321

Combining Myocardial Strain and Cardiac CT to Optimize Left Ventricular Lead Placement in CRT Treatment

Individually Tailored Cardiac Resynchronization Therapy - Combing Myocardial Strain and Cardiac CT to Optimize Left Ventricular Lead Placement in Cardiac Resynchronization Therapy

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
100 (actual)
Sponsor
Region Skane · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

For patients with advanced heart failure, Cardiac Resynchronization Therapy (CRT) has been a major improvement. The treatment improves symptoms and prolongs life in selected patients with heart failure. However, with the current selection criteria and methods for implanting the pacemaker, only 60-70% of the patients derive significant benefit from the treatment. New imaging techniques, including advanced ultrasound and computed tomography, in combination with new versatile multi-pole electrodes, have made an individually tailored therapy possible. Using these techniques in combination, the study will investigate the effect of individually based "optimal" placement of the pacemaker electrodes vs. standard care. The optimal LV electrode position is defined as pacing a viable segment with the latest mechanical delay, targeting a specific segment of the coronary sinus as visualised on cardiac CT. The hypothesis is that this will increase the number of positive responders from 65% to 85%.

Conditions

Interventions

TypeNameDescription
OTHERImaging guided LV lead positioningLV lead positioning guided by echocardiography (mechanical strain evaluation by speckle tracking) in combination with cardiac CT. A viable segment with the latest mechanical activation is targeted, and an appropriate "optimal" cardiac vein segment is then chosen using the CT images.

Timeline

Start date
2011-08-01
Primary completion
2018-01-01
Completion
2018-12-01
First posted
2011-08-31
Last updated
2019-03-28

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT01426321. Inclusion in this directory is not an endorsement.