Metabolic Mapping and Cardiac Resynchronization

NCT03420833 | Completed Results FDA Device

• 2 other identifiers: 17-0033591R01HL134864-01A1
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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, adjusted for the individual's body surface area.

  baseline, 12 months

• Number of Subjects 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.

  Approximately 12 months

Secondary Outcomes (5)

• Number of Subjects Admitted to the Hospital for Heart Failure

  Approximately 12 months

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

  6 months, 12 months

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

  Approximately 12 months

• Change in Left Ventricular Ejection Fraction (LVEF)

  Baseline, 12 months

• Number of Subjects Who Die in One Year

  Approximately 12 months

Study Arms (2)

CRT-On first, then CRT-Off

EXPERIMENTAL

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)

CRT-Off first, then CRT-On

EXPERIMENTAL

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)

Interventions

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.

Also known as: BIOTRONIK Evia HF-T

CRT-Off first, then CRT-On; CRT-On first, then CRT-Off

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yong-Mei Cha: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Biotronik SE & Co. KG: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Yong-Mei Cha
• Organization: Mayo Clinic

ycha@mayo.edu

507-255-0774

Study Officials

• Yong-Mei Cha, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants randomly assigned to have CRT-ON or OFF. At 6 months, participant CRT function will be crossed over.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Investigator

Model Details: Single-center, randomized cross-over study

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 5, 2018
• Study Start: August 20, 2018
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: January 23, 2025
• Results First Posted: January 23, 2025

Record last verified: 2025-01

Locations

US (1)