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Completed

NCT Number: NCT01426321

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

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%.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skane University Hospital

Lund, 221 85, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Imaging guided LV lead positioning

Other

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.

Primary outcomes

  1. Positive response to CRT treatment

    Time frame: 6 months

    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").

Secondary outcomes

  1. Response to CRT (on-treatment analysis)

    Time frame: 6 months

    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.

  2. Heart failure morbidity

    Time frame: 6 months 2 years and 5 years

    Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to hospitalisation for worsening of heart failure

  3. Morbidity and mortality

    Time frame: 6 months 2 years and 5 years

    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).

  4. Mortality

    Time frame: 6 months, 2 years and 5 years

    Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to all cause mortality

  5. Left ventricular dyssynchrony

    Time frame: 6 months

    Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to echocardiography measured changes in LV dyssynchrony

  6. Ventricular tachycardia

    Time frame: 6 months 2 years and 5 years

    Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to number of treated ventricular tachycardia episodes

  7. Quality of life

    Time frame: 6 months 2 years 5 years

    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

  8. Myocardial viability

    Time frame: Peroperative

    Evaluate the concordance in viability assessment using myocardial strain evaluation (echocardiography) compared to cardiac MRI.

  9. Biochemical markers of heart failure

    Time frame: 6 months

    Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to the change in blood natriuretic peptide (BNP) levels

  10. Left ventricular systolic function

    Time frame: 6 months

    Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to the change in LV ejection fraction

  11. Myocardial viability

    Time frame: 6 months

    Evaluate the concordance between echocardiography (strain evaluation with speckle tracking) and cardiac MRI viability images (late gadolinium enhancement).

  12. MRI left ventricular dyssynchrony

    Time frame: 6 months

    Evaluate if MRI dyssynchroni evaluation has incremental value over echocardiography alone for predicting the effect of cardiac resynchronization therapy.

  13. Left ventricular diastolic dimension

    Time frame: 6 months

    Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to the change in left ventricular diastolic dimension

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Crafoord Foundation

Registry information

Official study title

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

Acronym: CRT clinic

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Aug 31, 2011
Registry last updated
Mar 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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