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OpenTrials
Completed

NCT Number: NCT01439529

ECG Optimization of CRT: Evaluation of Mid-term Response

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients with standard indication of cardiac resynchronization

  • 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

Treatment and study plan

Device programming: nominal

Other

CRT device is programmed to nominal values

Programming optimization by QRS

Other

CRT device is programmed by QRS optimization

Primary outcomes

  1. Clinical response

    Time frame: 12 months

    Clinical response: survival without heart transplantation or death and >10% increased distance in the 6MWT.

Secondary outcomes

  1. Echocardiographic response

    Time frame: 12 months

    Echocardiographic response: >15% decrease in LV end-systolic volume and survival without heart transplantation or death.

  2. Pacing/sensing AV delay difference

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

Optimization of Response to Cardiac Resynchronization Therapy by Electrocardiogram: an Assessment of Medium-term Response

Acronym: BEST

Important dates

Study start
2009
Primary completion
2016
Study completion
2017
First posted
Sep 23, 2011
Registry last updated
Aug 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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