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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01426321
First Posted: August 31, 2011
Last Update Posted: August 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Crafoord Foundation
Information provided by (Responsible Party):
Region Skane
  Purpose

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%.


Condition Intervention
Heart Failure Other: Imaging guided LV lead positioning

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Individually Tailored Cardiac Resynchronization Therapy - Combing Myocardial Strain and Cardiac CT to Optimize Left Ventricular Lead Placement in Cardiac Resynchronization Therapy

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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

  • 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).

  • 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

  • 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

  • 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

  • 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

  • Myocardial viability [ Time Frame: Peroperative ]
    Evaluate the concordance in viability assessment using myocardial strain evaluation (echocardiography) compared to cardiac MRI.

  • 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

  • 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

  • Myocardial viability [ Time Frame: 6 months ]
    Evaluate the concordance between echocardiography (strain evaluation with speckle tracking) and cardiac MRI viability images (late gadolinium enhancement).

  • 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.

  • 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


Enrollment: 100
Study Start Date: August 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Imaging guided LV lead positioning 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.
No Intervention: Standard LV lead positioning
The LV lead position is decided at the discretion of the treating physician. Cardiac CT images are available for viewing, but no echocardiography data regarding segmental myocardial strain are available.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01426321


Locations
Sweden
Skane University Hospital
Lund, Sweden, 221 85
Sponsors and Collaborators
Region Skane
Crafoord Foundation
Investigators
Principal Investigator: Rasmus Borgquist, MD PhD Region Skane
  More Information

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01426321     History of Changes
Other Study ID Numbers: CRTCLIN01
First Submitted: August 25, 2011
First Posted: August 31, 2011
Last Update Posted: August 17, 2017
Last Verified: August 2017

Keywords provided by Region Skane:
Cardiac resynchronization therapy
Echocardiography
Cardiac computed tomography

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases