Optimizing CRT With ECGI

NCT03492788 | Terminated DMC

• 1 other identifier: 201712146
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

CRT is delivered from two electrodes on opposite sides of the heart \[right (RV) and left ventricle (LV)\] delivering stimulation for more efficient heart beats. There is flexibility in the sequence and temporal staggering of the stimulation from these two electrodes with a different optimum for different patients. However, standard techniques to figure out the optimal stimulation strategy like standard 12-lead surface electrical recording (ECG) or routine ultrasound have failed. The investigators have developed ECG imaging (ECGI) with 250 electrode surface recording combined with CT scan to reconstruct high resolution 4-dimensional panoramic electrical maps of the heart. The study seeks to enroll 56 patients undergoing CRT in a clinical trail to evaluate short and long term impact of using ECGI for optimal programming of CRT.

Conditions

Heart Failure, Systolic; Left Bundle-Branch Block

Keywords

cardiac resynchronization therapy; electrocardiographic imaging

Outcome Measures

Primary Outcomes (1)

• LV reverse remodeling

  Echocardiographically evaluated % reduction in LV end-systolic volume (LVESV) from baseline is the primary outcome measure. A reduction in the LVESV is a validated surrogate marker of improved HF outcomes including reduced hospitalizations and increased survival.

  6 months

Secondary Outcomes (3)

• Quality-of-life

  6 months

• Functional performance

  6 months

• Prognostic biomarker

  6 months

Study Arms (2)

ECGI-optimized VV-offset

ACTIVE COMPARATOR

Other: ECGI-optimized VV-offset

Zero VV-offset

PLACEBO COMPARATOR

Other: Zero VV-offset

Interventions

ECGI-optimized VV-offset OTHER

ECGI guided optimization of VV offset programming of CRT device

ECGI-optimized VV-offset

Zero VV-offset OTHER

Standard-of-care nominal (zero VV-offset) programming of CRT device

Zero VV-offset

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥18 years of age who are able to give consent, having systolic heart failure despite treatment with guideline directed medical therapy, undergoing successful CRT device implant for standard clinical indications, expected to have over 95% heart beats resynchronized by the pacing device (absence of competing arrhythmias), and have RV or LV pacing latency (stimulus to rapid QRS deflection) ≥30 msec

You may not qualify if:

• Patients unable to comply with the study follow-up, life expectancy ≤1 year, suboptimal LV lead location (septal or apical)

Sponsors & Collaborators

• Washington University School of Medicine: lead
• American College of Cardiology: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Heart Failure, Systolic; Bundle-Branch Block

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Heart Block; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amit Noheria, MBBS, SM

  Assistant Professor of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: April 10, 2018
• Study Start: December 28, 2017
• Primary Completion: October 5, 2018
• Study Completion: October 5, 2018
• Last Updated: May 1, 2019

Record last verified: 2019-04

Locations

US (1)