Metabolic Mapping and Cardiac Resynchronization

Metabolic Mapping and Cardiac Resynchronization (Aim 1)

The purpose of this study is to gather information on the safety and effectiveness of cardiac resynchronization therapy (CRT) in patients who have mild heart failure (HF) and left bundle branch block (LBBB).

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Cardiac resynchronization therapy pacemaker (CRT-P)

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brian Liddell; Phone Number: (507) 255-0774; Email: Liddell.Brian@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• LVEF 35%-50%
• NYHA class I-II
• QRS duration of ≥120ms
• Left bundle branch block (LBBB)
• Patient is able to receive a transvenous pectoral CRT implant
• Patient is able to sign informed consent
• Two echocardiograms are required to confirm a stable reduced LVEF
• Patient is on optimal and stable medical therapy (ACE inhibitor or AT1 blocker, beta blocker, etc. over the last 6 months)

Exclusion Criteria:

• Advanced comorbid conditions with life expectancy <1 year
• Patient is <18 of years of age
• Patient has a CRT device
• Female patients who is pregnant or not on a reliable form of birth control. Women of childbearing potential are required to have negative pregnancy test within the 7 days prior to device implant
• Unwilling or unable to return for required follow-up visits
• Patient decides study participation is cost-prohibited

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CRT-On first, then CRT-Off; Subjects will be randomized to have the cardiac resynchronization therapy pacemaker (CRT-P) programmed on in the first intervention period, and after six months the CRT function will be turned off in the second intervention period.	Device: Cardiac resynchronization therapy pacemaker (CRT-P); A pacemaker is an implantable, battery-powered minicomputer that sends electrical pulses to the heart whenever it detects a slow heartbeat or no heartbeat at all. When it senses a slow heartbeat or lack of heartbeat, it sends electrical impulses to restore a normal rhythm. Cardiac resynchronization therapy pacemakers, or CRT-Ps, treat heart failure by resynchronizing electrical impulses in the heart's four chambers, improving the heart's ability to pump blood to the body effectively and efficiently.; Other Names: BIOTRONIK Evia HF-T
Experimental: CRT-Off first, then CRT-On; Subjects will be randomized to have the cardiac resynchronization therapy pacemaker (CRT-P) programmed off in the first intervention period, and after six months the CRT function will be turned on in the second intervention period.	Device: Cardiac resynchronization therapy pacemaker (CRT-P); A pacemaker is an implantable, battery-powered minicomputer that sends electrical pulses to the heart whenever it detects a slow heartbeat or no heartbeat at all. When it senses a slow heartbeat or lack of heartbeat, it sends electrical impulses to restore a normal rhythm. Cardiac resynchronization therapy pacemakers, or CRT-Ps, treat heart failure by resynchronizing electrical impulses in the heart's four chambers, improving the heart's ability to pump blood to the body effectively and efficiently.; Other Names: BIOTRONIK Evia HF-T

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Left Ventricle End-Systolic Volume Index (LVESVI)	LVESVI is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole.	baseline, approximately 12 months
Number of Subjects Not Experiencing Any System-Related Complications	This is a composite endpoint; system-related complications could include any of the following: device pocket hematoma, pneumothorax, myocardial perforation, lead dislodgement, lead revision and device-related infection.	baseline, approximately 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Admitted to the Hospital for Heart Failure		Approximately 12 months
Number of Subjects Whose N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) Increases by 30%	The NT-proBNP is a substance that is produced in the heart and released when the heart is stretched and working hard to pump blood.	Approximately 12 months
Number of Subjects Who Experience Sustained Ventricular Tachycardia or Fibrillation Greater than 30 Seconds	In ventricular tachycardia, abnormal electrical signals in the ventricles cause the heart to beat faster than normal, usually 100 or more beats a minute, out of sync with the upper chambers. Ventricular fibrillation is the most serious cardiac rhythm disturbance. The lower chambers quiver and the heart can't pump any blood, causing cardiac arrest.	Approximately 12 months
Number of Subjects Who Experience a Decrease in Left Ventricular Ejection Fraction (LVEF) to ≤35%	LVEF refers to how well your left ventricle (or right ventricle) pumps blood with each heart beat. Most times, EF refers to the amount of blood being pumped out of the left ventricle each time it contracts. The left ventricle is the heart's main pumping chamber.	Approximately 12 months
Number of Subjects Who Die in One Year		Approximately 12 months

Collaborators and Investigators

• Sponsor: Yong-Mei Cha
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Biotronik SE & Co. KG
• Investigators: Principal Investigator: Yong-Mei Cha, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2018
• Primary Completion (Actual): December 19, 2023
• Study Completion (Actual): December 19, 2023

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: January 29, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 17-003359; 1R01HL134864-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes