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

This study is currently recruiting participants.
Verified July 2013 by Region Skane
Sponsor:
Collaborator:
Crafoord Foundation
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01426321
First received: August 25, 2011
Last updated: July 5, 2013
Last verified: July 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Evaluate the concordance in viability assessment using myocardial strain evaluation (echocardiography) compared to cardiac MRI.

  • Biochemical markers of heart failure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to the change in left ventricular diastolic dimension


Estimated Enrollment: 160
Study Start Date: August 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426321

Contacts
Contact: Rasmus Borgquist, MD PhD +4646174281 rasmus.borgquist@med.lu.se
Contact: Carolina Ehrencrona +4646176219 carolina.ehrencrona@skane.se

Locations
Sweden
Skane University Hospital Recruiting
Lund, Sweden, 221 85
Contact: Rasmus Borgquist, MD PhD         
Principal Investigator: Rasmus Borgquist, MD PhD         
Sub-Investigator: Anders Roijer, MD PhD         
Sub-Investigator: Marcus Carlsson, MD PhD         
Sub-Investigator: Lisa Ander Olsson, MD         
Sub-Investigator: Pyotr Platonov, MD PhD         
Sub-Investigator: Johan Brandt, MD PhD         
Sub-Investigator: Carl-Johan Hoijer, MD PhD         
Sub-Investigator: Lingwei Wang, MD PhD         
Sponsors and Collaborators
Region Skane
Crafoord Foundation
Investigators
Principal Investigator: Rasmus Borgquist, MD PhD Region Skane
  More Information

No publications provided

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01426321     History of Changes
Other Study ID Numbers: CRTCLIN01
Study First Received: August 25, 2011
Last Updated: July 5, 2013
Health Authority: Sweden: The National Board of Health and Welfare

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014