Effects of CRT Optimization as Assessed by Cardiac MR

Description

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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).

Effects of CRT Optimization on LV Mechanical Synchrony, Structure, and Function in CRT Patients as Assessed by Cardiac MR

Effects of CRT Optimization as Assessed by Cardiac MR

Condition
Heart Failure, Systolic
Intervention / Treatment

-

Contacts and Locations

Minneapolis

Minneapolis Heart Institute - Abbott Northwestern Hospital (MHI West), Minneapolis, Minnesota, United States, 55407

Saint Paul

United Heart & Vascular Clinic - Nasseff Specialty Center (MHI East), Saint Paul, Minnesota, United States, 55102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Currently on standard medical therapy
  • 2. CRT device in place for \> 4 months
  • 3. Non-responder (ejection fraction improvement with CRT \< 5%) or incomplete responder (ejection fraction \< 40%)
  • 4. Suboptimal electrical wavefront fusion at current CRT programming as observed on 12-lead ECG
  • 5. Left bundle branch block, interventricular conduction delay or right ventricular paced underlying QRS complex
  • 6. Age \> 18 years
  • 1. Decompensated heart failure
  • 2. Right bundle branch block
  • 3. Pregnancy or lactation
  • 4. History of severe allergic reactions to ECG gels, electrode adhesives, and/or cardiac magnetic resonance contrast (e.g. gadolinium)
  • 5. Implantation of pacing lead in the his bundle or left bundle branch
  • 6. Frequent ventricular ectopy as defined as \>10% premature ventricular contraction burden by either device interrogation or Holter monitor, or sustained ventricular tachycardia/ventricular fibrillation
  • 7. Uncontrolled atrial fibrillation (HR \> 100 bpm)
  • 8. 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)

Ages Eligible for Study

18 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Allina Health System,

Alan J Bank, MD, PRINCIPAL_INVESTIGATOR, Allina Heath System

Study Record Dates

2025-04-01