Image Supported Lead Placement in CRT

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-08

Study Completion Date

2025-10-31

Brief Summary

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

Cardiac resynchronization therapy (CRT) is an established pacemaker therapy for patients with symptomatic chronic heart failure, but is hampered by a non-response rate of 30-40%. Optimising left ventricular (LV) lead placement is the cornerstone of improving treatment. The optimal location for the lead is remote from scar but within segments demonstrating late electromechanical activation. The present study aims to investigate the efficacy and clinical effect of the use of real-time guided lead placement using cardiac MRI and fluoroscopy in a blinded, multicenter, randomized controlled trial.

Related Clinical Trials

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

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

NCT01426321

Heart Failure

COMPLETED NA

Effect of Targeting Left Ventricular Lead Position on the Rate of Response to Cardiac Resynchronization Therapy.

NCT00399594

Heart Failure, Congestive Cardiac Pacing, Artificial Defibrillators

COMPLETED PHASE2/PHASE3

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

NCT01323686

Heart Failure

COMPLETED NA

Optimal Coronary Sinus Lead Implantation Using Intracardiac Impedography and Magnetic Resonance Imaging

NCT01129635

Heart Failure, Systolic Left Bundle Branch Block

COMPLETED NA

Image Guided Mapping for Cardiac Pacing Intervention

NCT01638754

Heart Failure

COMPLETED NA

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

DOUBLE

Participants Outcome Assessors

Study Groups

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

Intervention group

Live visualised, fluoroscopy-fused, image-guided, left ventricular lead placement on the basis of avoiding scar and targeting late mechanically activated segments.

Group Type EXPERIMENTAL

CARTBox

Intervention Type DEVICE

CARTBox performs analysis of cardiac MRI scans. The result is a treatment file that displays optimal targets for left ventricular lead implantation in CRT. This file will be used as an overlay with live fluoroscopy during the implantation procedure in the intervention group.

Control group

Empirical standard-of-care left ventricular lead placement, in line with current CRT implantation guidelines with electrical guiding on the basis of Q-LV sense.

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.

CARTBox

CARTBox performs analysis of cardiac MRI scans. The result is a treatment file that displays optimal targets for left ventricular lead implantation in CRT. This file will be used as an overlay with live fluoroscopy during the implantation procedure in the intervention group.

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* Heart failure with LV ejection fraction ≤ 35%;
* New York Heart Association class II, III, or IV (ambulatory);
* Optimal medical treatment that is tolerable;
* Left bundle branch block (LBBB) and QRS ≥ 130 ms, OR non-LBBB and QRS ≥ 150 ms.

Exclusion Criteria

* Pregnancy or lactation;
* Subjects with impaired renal function (severe renal insufficiency, GFR \< 30 ml/min/1.73m2);
* Atrial fibrillation or atrial fibrillation during MRI
* Documented allergic reaction to gadolinium;
* Impossibility to undergo an MRI scan;
* Participation in another clinical study that prohibits any procedures other than standard.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No