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Completed

NCT Number: NCT01323686

Empiric Versus Imaging Guided Left Ventricular Lead Placement in Cardiac Resynchronization Therapy

The aim of this study is to investigate if imaging guided optimal left ventricular (LV) lead placement improves the response rate to cardiac resynchronization therapy (CRT). Consecutive patients meeting the standard criteria for CRT are included in a prospective, double-blinded, randomized trial to LV lead positioning either 1) guided by cardiac imaging using echocardiography, single-photon emission computed tomography, and visualization of cardiac venous anatomy (cardiac computed tomography (CT), venography) to target an epicardial vein at the site of latest mechanical activation without scar tissue or 2) using standard LV lead placement.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiology, Aarhus University Hospital, Skejby

Aarhus N, DK-8200, Denmark

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.
  • ECG with QRS ≥ 120 milliseconds and left bundle branch block (LBBB) or paced QRS ≥ 180 milliseconds.
  • LV systolic dysfunction (Ejection Fraction ≤ 35%).
  • written informed consent.

Exclusion criteria

  • Expected lifetime < 6 months.
  • Recent myocardial infarction (< 3 months).
  • Pregnant or lactating.
  • Inadequate echocardiographic images for determination of site with latest mechanical activation
  • No written informed consent.

Treatment and study plan

Imaging guided optimal LV lead placement

Other

LV lead placement guided by cardiac imaging using echocardiography, single-photon emission computed tomography, and CT to target a cardiac vein at the site of latest mechanical activation without scar tissue.

Visualization of cardiac venous anatomy is performed using cardiac CT if not contraindicated by depressed renal function (estimated glomerular filtration rate <30 ml/min) or allergy to contrast media. In that case, a coronary venogram is used.

Primary outcomes

  1. Number of participants with clinical response to CRT

    Time frame: 6 months after CRT implantation

    Response to CRT defined as a combination of survival, free of hospitalization for heart failure, and improved functional status. The primary endpoint is attained if the patient is registered for one of the following three events:

    • Death from any cause.
    • Hospitalization for heart failure.
    • No improvement in New York Heart Association (NYHA) functional class and <10% improvement in 6-minutes hall walk at end of study period.

Secondary outcomes

  1. All cause mortality

    Time frame: 6 months after CRT implantation

  2. Hospitalization for heart failure

    Time frame: 6 months after CRT implantation

  3. Changes in NYHA functional class

    Time frame: 6 months after CRT implantation

  4. Changes in 6-Minutes Hall Walk

    Time frame: 6 months after CRT implantation

  5. Changes in Quality of Life

    Time frame: 6 months after CRT implantation

    Using Minnesota Living with Heart Failure questionnaire.

  6. Changes in Biochemical marker of heart failure

    Time frame: 6 months after CRT implantation

    Nt-ProBNP

  7. Changes in LV Ejection Fraction

    Time frame: 6 months after CRT implantation

  8. Changes of LV end-diastolic volume

    Time frame: 6 months after CRT implantation

  9. Changes of LV end-systolic volume

    Time frame: 6 months after CRT implantation

  10. Changes of LV dyssynchrony

    Time frame: 6 months after CRT implantation

  11. Changes of mitral regurgitation grade

    Time frame: 6 months after CRT implantation

  12. Duration of CRT implantation

    Time frame: During CRT implantation

  13. Complications

    Time frame: 6 months after CRT implantation

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Acronym: ImagingCRT

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 28, 2011
Registry last updated
Sep 5, 2014

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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