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Completed

NCT Number: NCT03420833

Metabolic Mapping and Cardiac Resynchronization

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).

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Left Ventricular Ejection Fraction (LVEF) 35%-50%
  • New York Heart Association (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 angiotensin II type 1 (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

Treatment and study plan

Cardiac resynchronization therapy pacemaker (CRT-P)

Device

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

Primary outcomes

  1. Change in Left Ventricle End-Systolic Volume Index (LVESVI)

    Time frame: baseline, 12 months

    LVESVI is the volume of blood in the left ventricle at the end of contraction, or systole, adjusted for the individual's body surface area.

  2. Number of Subjects Experiencing Any System-Related Complications

    Time frame: Approximately 12 months

    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.

Secondary outcomes

  1. Number of Subjects Admitted to the Hospital for Heart Failure

    Time frame: Approximately 12 months

    The total number of subjects hospitalized for heart failure during the study.

  2. Change in N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) by CRT Randomization From 6 Months to 12 Months

    Time frame: 6 months, 12 months

    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, measured in pg/mL. The change was calculated as the value at 12 months minus the value at 6 months.

  3. Number of Subjects Who Experience Sustained Ventricular Tachycardia or Fibrillation Greater Than 30 Seconds

    Time frame: Approximately 12 months

    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.

  4. Change in Left Ventricular Ejection Fraction (LVEF)

    Time frame: Baseline, 12 months

    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.

  5. Number of Subjects Who Die in One Year

    Time frame: Approximately 12 months

    The total number of subjects to die for any reason during the study.

Sponsors and collaborators

Lead sponsor

Yong-Mei Cha

Other

Collaborators

  • Biotronik SE & Co. KG
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Metabolic Mapping and Cardiac Resynchronization (Aim 1)

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Feb 5, 2018
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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