RECRUITING

Effects of CRT Optimization as Assessed by Cardiac MR

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2021-07-01
Study Completion:2025-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04763460

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.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Currently on standard medical therapy
  2. 2. CRT device in place for \> 4 months
  3. 3. Non-responder (ejection fraction improvement with CRT \< 5%) or incomplete responder (ejection fraction \< 40%)
  4. 4. Suboptimal electrical wavefront fusion at current CRT programming as observed on 12-lead ECG
  5. 5. Left bundle branch block, interventricular conduction delay or right ventricular paced underlying QRS complex
  6. 6. Age \> 18 years
  1. 1. Decompensated heart failure
  2. 2. Right bundle branch block
  3. 3. Pregnancy or lactation
  4. 4. History of severe allergic reactions to ECG gels, electrode adhesives, and/or cardiac magnetic resonance contrast (e.g. gadolinium)
  5. 5. Implantation of pacing lead in the his bundle or left bundle branch
  6. 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. 7. Uncontrolled atrial fibrillation (HR \> 100 bpm)
  8. 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)

Contacts and Locations

Study Contact

Christopher D Brown
CONTACT
651-241-2806
christopher.brown2@allina.com

Principal Investigator

Alan J Bank, MD
PRINCIPAL_INVESTIGATOR
Allina Heath System

Study Locations (Sites)

Minneapolis Heart Institute - Abbott Northwestern Hospital (MHI West)
Minneapolis, Minnesota, 55407
United States
United Heart & Vascular Clinic - Nasseff Specialty Center (MHI East)
Saint Paul, Minnesota, 55102
United States

Collaborators and Investigators

Sponsor: Allina Health System

  • Alan J Bank, MD, PRINCIPAL_INVESTIGATOR, Allina Heath System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-01
Study Completion Date2025-04-01

Study Record Updates

Study Start Date2021-07-01
Study Completion Date2025-04-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Heart Failure, Systolic