Effects of CRT Optimization as Assessed by Cardiac MR

NCT04763460 | Withdrawn FDA Device

• 1 other identifier: IRBnet#: 1706252
• Study Type: interventional
• Target: N/A
• 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 CRT device programming in patients considered non-responders to CRTusing information obtained from standard ECG machines, and to assess acute and chronic effects of CRT optimization using cardiac magnetic resonance imaging (CMR).

Conditions

Heart Failure, Systolic

Keywords

Cardiac Resynchronization Therapy; Pacing; Electrocardiography; Cardiac Magnetic Resonance Imaging; Echocardiography; Optimization of Cardiac Devices; Heart Failure

Outcome Measures

Primary Outcomes (8)

• Acute changes in left ventricular mechanical synchrony in study population

  Acute changes, measured by cardiac magnetic resonance imaging, in left ventricular mechanical synchrony at underlying rhythm, baseline CRT programming, and optimal programming derived from electrocardiographic assessment in all patients.

  During Baseline Assessment

• Acute changes in left ventricular regional wall motion in study population

  Acute changes, measured by cardiac magnetic resonance imaging, in left ventricular wall motion at underlying rhythm, baseline CRT programming, and optimal programming derived from electrocardiographic assessment in all patients.

  During Baseline Assessment

• Acute changes in left ventricular end-diastolic volume in study population

  Acute changes, measured by cardiac magnetic resonance imaging, in left ventricular end-diastolic volume at underlying rhythm, baseline CRT programming, and optimal programming derived from electrocardiographic assessment in all patients.

  During Baseline Assessment

• Acute changes in left ventricular end-systolic volume in study population

  Acute changes, measured by cardiac magnetic resonance imaging, in left ventricular end-systolic volume at underlying rhythm, baseline CRT programming, and optimal programming derived from electrocardiographic assessment in all patients.

  During Baseline Assessment

• Chronic changes in left ventricular mechanical synchrony

  Chronic changes, measured by cardiac magnetic resonance imaging and echocardiography, in left ventricular mechanical synchrony between the experimental and active comparator group.

  Baseline to 12 months

• Chronic changes in left ventricular regional wall motion

  Chronic changes, measured by cardiac magnetic resonance imaging and echocardiography, in left ventricular regional wall motion between the experimental and active comparator group.

  Baseline to 12 months

• Chronic changes in left ventricular end-diastolic volume

  Chronic changes, measured by cardiac magnetic resonance imaging and echocardiography, in left ventricular end-diastolic volume between the experimental and active comparator group.

  Baseline to 12 months

• Chronic changes in left ventricular end-systolic volume

  Chronic changes, measured by cardiac magnetic resonance and echocardiographic imaging, in left ventricular end-systolic volume between the experimental and active comparator group.

  Baseline to 12 months

Secondary Outcomes (2)

• Change in 6 Minute Hall Walk (6MHW)

  Baseline to 12 months

• Change in Kansis City Cardiomyopathy Questionnaire (KCCQ)

  Baseline to 12 months

Other Outcomes (1)

• Correlation in electrical dyssynchrony and left ventricular function in study population

  Baseline to 12 months

Study Arms (2)

Baseline CRT programming

ACTIVE COMPARATOR

The comparator arm patients will remain at baseline CRT programming for the first 6 months, and then will crossover to the experimental arm and CRT device will be programmed to optimal settings derived from the electrocardiographic assessment for the following 6 months.

Device: Programming of CRT device settings

Electrocardiography-guided optimal CRT programming

EXPERIMENTAL

The experimental arm patients will have CRT device programmed based on the electrocardiographic assessment for 12 months.

Device: Programming of CRT device settings

Interventions

Programming of CRT device settings DEVICE

Reprogramming of CRT device to maximize the benefit derived from the electrocardiographic assessment.

Baseline CRT programming; Electrocardiography-guided optimal CRT programming

Eligibility Criteria

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

You may qualify if:

• Currently on standard medical therapy
• CRT device in place for \> 4 months
• Non-responder (ejection fraction improvement with CRT \< 5%) or incomplete responder (ejection fraction \< 40%)
• Suboptimal electrical wavefront fusion at current CRT programming as observed on 12-lead ECG
• Left bundle branch block, interventricular conduction delay or right ventricular paced underlying QRS complex
• Age \> 18 years

You may not qualify if:

• Decompensated heart failure
• Right bundle branch block
• Pregnancy or lactation
• History of severe allergic reactions to ECG gels, electrode adhesives, and/or cardiac magnetic resonance contrast (e.g. gadolinium)
• Implantation of pacing lead in the his bundle or left bundle branch
• Frequent ventricular ectopy as defined as \>10% premature ventricular contraction burden by either device interrogation or Holter monitor, or sustained ventricular tachycardia/ventricular fibrillation
• Uncontrolled atrial fibrillation (HR \> 100 bpm)
• Patient is enrolled in concurrent research study that would potentially confound the results of this study (noting: co-enrollment acceptable if patient is enrolled in registry study)

Sponsors & Collaborators

• Minneapolis Heart Institute Foundation: lead

Study Sites (2)

Minneapolis Heart Institute - Abbott Northwestern Hospital (MHI West)

Minneapolis, Minnesota, 55407, United States

Location

United Heart & Vascular Clinic - Nasseff Specialty Center (MHI East)

Saint Paul, Minnesota, 55102, United States

Location

MeSH Terms

Conditions

Heart Failure, Systolic; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Alan J Bank, MD

  Allina Heath System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients blinded to which group they are randomized and how their CRT device is programmed during the study. Individuals (readers) who perform cardiac magnetic resonance and echocardiographic imaging measurements blinded to patient randomization and CRT programming.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel (with 6 month crossover) 1:1 randomization - active comparator and experimental arm (note: at 6 month, the active comparator arm will crossover to the experimental arm)

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 21, 2021
• Study Start: June 1, 2023
• Primary Completion: March 2, 2026
• Study Completion: March 2, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)