Effects of CRT Optimization as Assessed by Cardiac MR

RECRUITING

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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

🗓️ Study Start (Actual) 1 July 2021

🗓️ Primary Completion (Estimated) 1 April 2024

✅ Study Completion (Estimated) 1 April 2025

👥 Enrollment (Estimated) 40

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Minneapolis, Minnesota, United States

📍 Saint Paul, Minnesota, United States

📋 Eligibility Criteria

Description

Inclusion 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

Exclusion Criteria:

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 (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ 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

First Submitted 12 February 2021
First Submitted that Met QC Criteria 18 February 2021
First Posted 21 February 2021

Study Record Updates

Last Update Submitted that Met QC Criteria 21 September 2021
Last Update Posted 27 September 2021
Last Verified September 2021