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ECG Optimization of CRT: Evaluation of Mid-term Response

NCT01439529 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2018-08-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Device programming: nominal

CRT device is programmed to nominal values

OTHER

Programming optimization by QRS

CRT device is programmed by QRS optimization

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    lead OTHER

Principal Investigators

  • Elena Arbelo, MD, PhD · Hospital Clinic Universitari de Barcelona

  • Lluís Mont, MD, PhD · Hospital Clínic Universitari de Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2016-09-30
Completion
2017-09-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01439529 on ClinicalTrials.gov