Empiric Versus Imaging Guided Left Ventricular Lead Placement in Cardiac Resynchronization Therapy
ImagingCRT
1 other identifier
interventional
182
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable heart-failure
Started Apr 2011
Typical duration for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2011
CompletedFirst Posted
Study publicly available on registry
March 28, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedSeptember 5, 2014
August 1, 2013
3 years
March 25, 2011
September 4, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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: 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.
6 months after CRT implantation
Secondary Outcomes (13)
All cause mortality
6 months after CRT implantation
Hospitalization for heart failure
6 months after CRT implantation
Changes in NYHA functional class
6 months after CRT implantation
Changes in 6-Minutes Hall Walk
6 months after CRT implantation
Changes in Quality of Life
6 months after CRT implantation
- +8 more secondary outcomes
Study Arms (2)
Imaging guided LV lead placement
EXPERIMENTALEmpiric LV lead placement
NO INTERVENTIONLV lead placement using standard clinical routine.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Cardiology, Aarhus University Hospital, Skejby
Aarhus N, DK-8200, Denmark
Related Publications (2)
Fyenbo DB, Norgaard BL, Blanke P, Sommer A, Duchscherer J, Kalk K, Kronborg MB, Jensen JM, McVeigh ER, Delgado V, Leipsic J, Nielsen JC. Geometric Changes in Mitral Valve Apparatus during Long-term Cardiac Resynchronization Therapy as Assessed with Cardiac CT. Radiol Cardiothorac Imaging. 2024 Oct;6(5):e230320. doi: 10.1148/ryct.230320.
PMID: 39360929DERIVEDSommer 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.
PMID: 23782792DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jens C. Nielsen, Professor, PhD, DMSc
Aarhus University Hospital
- PRINCIPAL INVESTIGATOR
Anders Sommer, MD
Aarhus University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2011
First Posted
March 28, 2011
Study Start
April 1, 2011
Primary Completion
April 1, 2014
Study Completion
September 1, 2014
Last Updated
September 5, 2014
Record last verified: 2013-08