ECG Optimization of CRT: Evaluation of Mid-term Response

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

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2017-09-30

Brief Summary

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

New simpler methods to optimize cardiac resynchronization therapy (CRT) are being evaluated, such as the use of the electrocardiogram.

In this prospective, double-blind, study, the investigators will evaluate:

Primary endpoint: To compare the clinical response to CRT in patients with the programming optimized by QRS versus the nominal suggested by the device.

Secondary endpoints:

1. To compare cardiac remodeling in patients with the programming optimized by QRS versus the nominal suggested by the device.
2. To evaluate the degree of asynchrony in both groups (nominal versus optimization by QRS) with respect to the intrinsic rhythm.
3. To evaluate the echocardiographic improvement in left ventricular (LV) filling in both groups.
4. To evaluate the differences in the optimal atrioventricular (AV) delay with atrial sensing or atrial pacing.

For that, 180 patients with an indication for CRT will be randomized to nominal programming of the device or optimization by the electrocardiogram for a narrower QRS. A clinical and echocardiographic evaluation will be done at baseline, 6 and 12 months.

Related Clinical Trials

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

CRTd Responders Optimization

NCT04547244

Heart Failure Heart Failure With Reduced Ejection Fraction Cardiac Death

COMPLETED

Optimization of CRT Using an ECG Vest

NCT02699944

Heart Failure

COMPLETED NA

Tissue Doppler Imaging (TDI) Versus Electrocardiography (ECG) Interventricular Pacing Delay Optimization in Cardiac Resynchronization Therapy (CRT)

NCT01179997

Heart Failure Cardiac Resynchronization Therapy

COMPLETED PHASE3

Triple-site Biventricular Stimulation in the Optimization of CRT

NCT02350842

Heart Failure

COMPLETED NA

Multi-lead ECG to Effectively Optimize Resynchronization Devices: New CRT Recipients

NCT04083690

Heart Failure, Systolic

UNKNOWN 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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

Nominal

CRT device is programmed with the nominal values.

Group Type ACTIVE_COMPARATOR

Device programming: nominal

Intervention Type OTHER

CRT device is programmed to nominal values

Narrow QRS

CRT device is programmed by QRS optimization

Group Type EXPERIMENTAL

Programming optimization by QRS

Intervention Type OTHER

CRT device is programmed by QRS optimization

Interventions

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

Device programming: nominal

CRT device is programmed to nominal values

Intervention Type OTHER

Programming optimization by QRS

CRT device is programmed by QRS optimization

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Ejection fraction ≤35%.
* QRS duration ≥120 ms.
* New York Heart Association Functional Class 2-4..
* Left ventricular diameter ≥55 mm.
* Optimal medical treatment.

Exclusion Criteria

* Patient refusal.
* Cardiopathy with a reversible cause.
* Prevision of heart transplantation.
* Atrial fibrillation.
* Complete AV block.
* AV delay \>250 ms.
* Right bundle branch block.
* Severe peripheral vascular disease.
* Other diseases with \< 1 year life expectancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No