Empiric Versus Imaging Guided Left Ventricular Lead Placement in Cardiac Resynchronization Therapy (ImagingCRT)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Imaging guided optimal LV lead placement
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility 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.
Sites / Locations
- Department of Cardiology, Aarhus University Hospital, Skejby
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Imaging guided LV lead placement
Empiric LV lead placement
Arm Description
LV lead placement using standard clinical routine.
Outcomes
Primary Outcome Measures
Number of participants with clinical response to CRT
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 Outcome Measures
All cause mortality
Hospitalization for heart failure
Changes in NYHA functional class
Changes in 6-Minutes Hall Walk
Changes in Quality of Life
Using Minnesota Living with Heart Failure questionnaire.
Changes in Biochemical marker of heart failure
Nt-ProBNP
Changes in LV Ejection Fraction
Changes of LV end-diastolic volume
Changes of LV end-systolic volume
Changes of LV dyssynchrony
Changes of mitral regurgitation grade
Duration of CRT implantation
Complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01323686
Brief Title
Empiric Versus Imaging Guided Left Ventricular Lead Placement in Cardiac Resynchronization Therapy
Acronym
ImagingCRT
Official Title
Empiric Versus Imaging Guided Left Ventricular Lead Placement in Cardiac Resynchronization Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
182 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Imaging guided LV lead placement
Arm Type
Experimental
Arm Title
Empiric LV lead placement
Arm Type
No Intervention
Arm Description
LV lead placement using standard clinical routine.
Intervention Type
Other
Intervention Name(s)
Imaging guided optimal LV lead placement
Intervention Description
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 Outcome Measure Information:
Title
Number of participants with clinical response to CRT
Description
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.
Time Frame
6 months after CRT implantation
Secondary Outcome Measure Information:
Title
All cause mortality
Time Frame
6 months after CRT implantation
Title
Hospitalization for heart failure
Time Frame
6 months after CRT implantation
Title
Changes in NYHA functional class
Time Frame
6 months after CRT implantation
Title
Changes in 6-Minutes Hall Walk
Time Frame
6 months after CRT implantation
Title
Changes in Quality of Life
Description
Using Minnesota Living with Heart Failure questionnaire.
Time Frame
6 months after CRT implantation
Title
Changes in Biochemical marker of heart failure
Description
Nt-ProBNP
Time Frame
6 months after CRT implantation
Title
Changes in LV Ejection Fraction
Time Frame
6 months after CRT implantation
Title
Changes of LV end-diastolic volume
Time Frame
6 months after CRT implantation
Title
Changes of LV end-systolic volume
Time Frame
6 months after CRT implantation
Title
Changes of LV dyssynchrony
Time Frame
6 months after CRT implantation
Title
Changes of mitral regurgitation grade
Time Frame
6 months after CRT implantation
Title
Duration of CRT implantation
Time Frame
During CRT implantation
Title
Complications
Time Frame
6 months after CRT implantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens C. Nielsen, Professor, PhD, DMSc
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anders Sommer, MD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Aarhus University Hospital, Skejby
City
Aarhus N
ZIP/Postal Code
DK-8200
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
23782792
Citation
Sommer A, Kronborg MB, Poulsen SH, Bottcher M, Norgaard BL, Bouchelouche K, Mortensen PT, Gerdes C, Nielsen JC. Empiric versus imaging guided left ventricular lead placement in cardiac resynchronization therapy (ImagingCRT): study protocol for a randomized controlled trial. Trials. 2013 Apr 26;14:113. doi: 10.1186/1745-6215-14-113.
Results Reference
derived
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Empiric Versus Imaging Guided Left Ventricular Lead Placement in Cardiac Resynchronization Therapy
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