ECG Optimization of CRT: Evaluation of Mid-term Response

NCT01439529 | Completed Phase 3 DMC

• 1 other identifier: BEST
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Failure

Keywords

Cardiac; Resynchronization; Therapy

Outcome Measures

Primary Outcomes (1)

• Clinical response

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

  12 months

Secondary Outcomes (2)

• Echocardiographic response

  12 months

• Pacing/sensing AV delay difference

  12 months

Study Arms (2)

Nominal

ACTIVE COMPARATOR

CRT device is programmed with the nominal values.

Other: Device programming: nominal

Narrow QRS

EXPERIMENTAL

CRT device is programmed by QRS optimization

Other: Programming optimization by QRS

Interventions

Device programming: nominal OTHER

CRT device is programmed to nominal values

Nominal

Programming optimization by QRS OTHER

CRT device is programmed by QRS optimization

Narrow QRS

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Related Publications (1)

• Trucco E, Tolosana JM, Arbelo E, Doltra A, Castel MA, Benito E, Borras R, Guasch E, Vidorreta S, Vidal B, Montserrat S, Sitges M, Berruezo A, Brugada J, Mont L. Improvement of Reverse Remodeling Using Electrocardiogram Fusion-Optimized Intervals in Cardiac Resynchronization Therapy: A Randomized Study. JACC Clin Electrophysiol. 2018 Feb;4(2):181-189. doi: 10.1016/j.jacep.2017.11.020. Epub 2018 Feb 1.

  PMID: 29749935 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Elena Arbelo, MD, PhD

  Hospital Clinic Universitari de Barcelona

  STUDY CHAIR

• Lluís Mont, MD, PhD

  Hospital Clínic Universitari de Barcelona

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator of the AF programme

Study Record Dates

• First Submitted: September 19, 2011
• First Posted: September 23, 2011
• Study Start: April 1, 2009
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2017
• Last Updated: August 2, 2018

Record last verified: 2018-08

Locations

ES (1)