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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01323686
First received: March 25, 2011
Last updated: September 4, 2014
Last verified: August 2013
  Purpose

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.


Condition Intervention
Heart Failure
Other: Imaging guided optimal LV lead placement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Empiric Versus Imaging Guided Left Ventricular Lead Placement in Cardiac Resynchronization Therapy

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Number of participants with clinical response to CRT [ Time Frame: 6 months after CRT implantation ] [ Designated as safety issue: No ]

    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:

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


Secondary Outcome Measures:
  • All cause mortality [ Time Frame: 6 months after CRT implantation ] [ Designated as safety issue: No ]
  • Hospitalization for heart failure [ Time Frame: 6 months after CRT implantation ] [ Designated as safety issue: No ]
  • Changes in NYHA functional class [ Time Frame: 6 months after CRT implantation ] [ Designated as safety issue: No ]
  • Changes in 6-Minutes Hall Walk [ Time Frame: 6 months after CRT implantation ] [ Designated as safety issue: No ]
  • Changes in Quality of Life [ Time Frame: 6 months after CRT implantation ] [ Designated as safety issue: No ]
    Using Minnesota Living with Heart Failure questionnaire.

  • Changes in Biochemical marker of heart failure [ Time Frame: 6 months after CRT implantation ] [ Designated as safety issue: No ]
    Nt-ProBNP

  • Changes in LV Ejection Fraction [ Time Frame: 6 months after CRT implantation ] [ Designated as safety issue: No ]
  • Changes of LV end-diastolic volume [ Time Frame: 6 months after CRT implantation ] [ Designated as safety issue: No ]
  • Changes of LV end-systolic volume [ Time Frame: 6 months after CRT implantation ] [ Designated as safety issue: No ]
  • Changes of LV dyssynchrony [ Time Frame: 6 months after CRT implantation ] [ Designated as safety issue: No ]
  • Changes of mitral regurgitation grade [ Time Frame: 6 months after CRT implantation ] [ Designated as safety issue: No ]
  • Duration of CRT implantation [ Time Frame: During CRT implantation ] [ Designated as safety issue: No ]
  • Complications [ Time Frame: 6 months after CRT implantation ] [ Designated as safety issue: No ]

Enrollment: 182
Study Start Date: April 2011
Study Completion Date: September 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Imaging guided LV lead placement Other: Imaging guided optimal LV lead placement

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.

No Intervention: Empiric LV lead placement
LV lead placement using standard clinical routine.

  Eligibility

Ages Eligible for Study:   40 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.
  • 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01323686

Locations
Denmark
Department of Cardiology, Aarhus University Hospital, Skejby
Aarhus N, Denmark, DK-8200
Sponsors and Collaborators
University of Aarhus
Investigators
Study Chair: Jens C. Nielsen, Professor, PhD, DMSc Department of Cardiology, Aarhus University Hospital, Skejby
Principal Investigator: Anders Sommer, MD Department of Cardiology, Aarhus University Hospital, Skejby
  More Information

No publications provided by University of Aarhus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01323686     History of Changes
Other Study ID Numbers: sksCRT
Study First Received: March 25, 2011
Last Updated: September 4, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 21, 2014