Metabolic Mapping and Cardiac Resynchronization

NCT ID: NCT03420833

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-20
• Study Completion Date: 2023-12-19

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cardiac resynchronization therapy pacemaker (CRT-P)

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Cardiac resynchronization therapy pacemaker (CRT-P)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

BIOTRONIK Evia HF-T

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yong-Mei Cha

OTHER

Sponsor Role: lead

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Biotronik SE & Co. KG

INDUSTRY

Sponsor Role: collaborator

Responsible Party

Yong-Mei Cha

Sponsor Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yong-Mei Cha, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R01HL134864-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-003359

Identifier Type: -

Identifier Source: org_study_id