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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Electrophysiological Optimization of Left Ventricular Lead Placement in CRT

NCT02346097

Congestive Heart Failure

COMPLETED NA

Evaluation of Left Ventricular (LV) Lead Positioning Using MediGuide

NCT01917266

Heart Failure

COMPLETED

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

NCT01426321

Heart Failure

COMPLETED NA

DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS

NCT03280862

Heart Failure Branch Block, Bundle

ACTIVE_NOT_RECRUITING NA

Optimal Left Ventricular Lead Positioning During Cardiac Resynchronisation Therapy; Comparison of Two Methods of Targeting

NCT03769272

Heart Failure

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Imaging guided LV lead placement

Group Type EXPERIMENTAL

Imaging guided optimal LV lead placement

Intervention Type 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.

Empiric LV lead placement

LV lead placement using standard clinical routine.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No