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

Heart Failure Clinical Trial

— CRT clinic  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01426321
• Other study ID #: CRTCLIN01
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: December 2018

Study information

• Verified date: March 2019
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Symptomatic heart failure (New York Heart Association functional class II - IV) despite stabile optimal medical therapy.

• Wide QRS = 120 milliseconds on standard ECG.

• LV systolic dysfunction (EF = 35%).

• Written informed consent.

• Accepted for CRT-P or CRT-D treatment

Exclusion Criteria:

• Life expectancy < 12 months.

• Recent myocardial infarction (< 3 months).

• Significant valve disease

• Chronic atrial fibrillation

• Pregnancy

• Severely impaired renal function (estimated glomerular filtration rate (eGFR) < 30 ml/min)

• Unable to give written informed consent.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Imaging guided LV lead positioning
LV 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.

Locations

Country	Name	City	State
Sweden	Skane University Hospital	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Crafoord Foundation

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive response to CRT treatment	The primary efficacy endpoint will evaluate the effect of echocardiography and cardiac CT guided placement of the left ventricular lead vs standard care (i.e. position of the left ventricular lead at the discretion of the treating physician).; Number of patients with positive response to CRT (YES or NO). A positive response is defined as survival in combination with either a reduction in end systolic left ventricular volume = 15% by echocardiography ("volume responder") and / or improvement = 1 NYHA class and =10% improvement in 6 minute hall walk test ("clinical responder").	6 months
Secondary	Response to CRT (on-treatment analysis)	Evaluate the effect of optimal LV placement (post hoc analysis of both groups) versus non-optimal LV lead placement. Optimal lead placement is defined as pacing from a viable segment with the latest mechanical activation (by myocardial strain measurement). Outcome measure is the same as in the primary outcome measure.	6 months
Secondary	Heart failure morbidity	Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to hospitalisation for worsening of heart failure	6 months 2 years and 5 years
Secondary	Morbidity and mortality	Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to a composite endpoint of all cause mortality and hospitalisation for worsening of heart failure (2 years and 5 years).	6 months 2 years and 5 years
Secondary	Mortality	Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to all cause mortality	6 months, 2 years and 5 years
Secondary	Left ventricular dyssynchrony	Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to echocardiography measured changes in LV dyssynchrony	6 months
Secondary	Ventricular tachycardia	Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to number of treated ventricular tachycardia episodes	6 months 2 years and 5 years
Secondary	Quality of life	Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to the change in the Minnesota Living with heart failure Quality of Life questionnaire	6 months 2 years 5 years
Secondary	Myocardial viability	Evaluate the concordance in viability assessment using myocardial strain evaluation (echocardiography) compared to cardiac MRI.	Peroperative
Secondary	Biochemical markers of heart failure	Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to the change in blood natriuretic peptide (BNP) levels	6 months
Secondary	Left ventricular systolic function	Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to the change in LV ejection fraction	6 months
Secondary	Myocardial viability	Evaluate the concordance between echocardiography (strain evaluation with speckle tracking) and cardiac MRI viability images (late gadolinium enhancement).	6 months
Secondary	MRI left ventricular dyssynchrony	Evaluate if MRI dyssynchroni evaluation has incremental value over echocardiography alone for predicting the effect of cardiac resynchronization therapy.	6 months
Secondary	Left ventricular diastolic dimension	Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to the change in left ventricular diastolic dimension	6 months