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

NCT04083690 | Unknown FDA Device

• 1 other identifier: IRBnet#: 1455594
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

Cardiac resynchronization therapy (CRT), or atrial-synchronized biventricular (BiV) pacing, is an FDA-approved device therapy option for heart failure (HF) patients with reduced left ventricular ejection fraction and electrical dyssynchrony. A traditional CRT device has pacing leads implanted within the right atrium (RA), the right ventricle (RV), and within a coronary vein overlying the lateral or posterior left ventricle (LV). Within the past decade, various multi-center randomized controlled trials have reported improved quality of life, aerobic exercise capacity, LV systolic function and structure, as well as decreased hospitalization rates and mortality among patients with HF. Despite improvements in CRT technology with multipoint pacing, quadripolar leads, and adaptive pacing algorithms, approximately 30% of patients do not clinically benefit and are considered non-responders. This study looks to optimize new CRT device recipients using information obtained from standard ECG machines.

Conditions

Heart Failure, Systolic

Keywords

Cardiac Resynchronization Therapy; Pacing; Echocardiography; Electrocardiography; Optimization; Heart Failure

Outcome Measures

Primary Outcomes (1)

• Change in left ventricular size

  Change in left ventricular end-systolic volume (LVESV), measured by echocardiogram, in patients in the experimental arm vs active comparator arm

  6 months

Secondary Outcomes (4)

• Change in left ventricular function

  6 months

• Change in left ventricular size

  6 months

• Change in left ventricular size

  6 months

• Change in left ventricular size

  6 months

Other Outcomes (1)

• Correlation of change in electrical dyssynchrony and LVESV

  12 months

Study Arms (2)

Standard CRT Programming, then ECG CRT Optimization

ACTIVE COMPARATOR

The control arm patients will have standard CRT programming for the first 6 months, and then will be reprogrammed based on the ECG CRT optimization information for the following 6 months

Device: Reprogramming of CRT Device Settings to Optimal Electrical Synchrony

ECG CRT Optimization

EXPERIMENTAL

The experimental arm patients will have CRT device reprogrammed based on the ECG CRT optimization information for 12 months.

Device: Reprogramming of CRT Device Settings to Optimal Electrical Synchrony

Interventions

Reprogramming of CRT Device Settings to Optimal Electrical Synchrony DEVICE

Reprogramming of CRT device to maximize the benefit based on the ECG CRT optimization information.

ECG CRT Optimization; Standard CRT Programming, then ECG CRT Optimization

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 (or their legal guardian) must be willing to provide informed consent and sign a data privacy authorization (HIPAA) form
• Age greater than or equal 18 years
• Pre-CRT EF less than or equal 40%
• Patients will be receiving or have received a first-time CRT device for standard clinical indications within \~2 months of study enrollment
• Adequate echocardiographic images for LV EF and LV ESV determination
• On optimal medical therapy

You may not qualify if:

• Patients who are pregnant or may become pregnant
• Patient has a history of severe allergic reactions from ECG gel/ electrode adhesives
• Patient has a His Bundle pacing lead
• Patient has right bundle branch block (RBBB)
• Patient is enrolled in concurrent research study that would potentially confound the results of this study
• Premature ventricular contraction (PVC) burden greater than or equal to 10%

Sponsors & Collaborators

• Allina Health System: lead

Study Sites (2)

Minneapolis Heart Institute (Abbott Northwestern Hospital)

Minneapolis, Minnesota, 55407, United States

RECRUITING

United Heart & Vascular Clinic

Saint Paul, Minnesota, 55102, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure, Systolic; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Alan J Bank, MD

  United Heart & Vascular - Allina Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher D Brown

CONTACT

651-241-2806; christopher.brown2@allina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients blinded to which study group they randomized and how their CRT device is programmed. Individuals (readers) who perform echocardiographic measurements blinded to patient randomization and CRT settings.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of Research - United Heart & Vascular Clinic

Model Details: 1:1 randomization - active comparator and experimental arm (note: at 6 months the control arm will crossover)

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: September 10, 2019
• Study Start: October 11, 2019
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2024
• Last Updated: June 9, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)