Metabolic Mapping and Cardiac Resynchronization

Heart Failure Clinical Trial

Official title:

Metabolic Mapping and Cardiac Resynchronization (Aim 1)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03420833
• Other study ID #: 17-003359
• Secondary ID: 1R01HL134864-01A
• Status: Completed
• Phase: N/A
• Start date: August 20, 2018
• Est. completion date: December 19, 2023

Study information

• Verified date: February 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: December 19, 2023
• Est. primary completion date: December 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Yong-Mei Cha	Biotronik SE & Co. KG, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of Subjects Admitted to the Hospital for Heart Failure		Approximately 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Subjects Who Die in One Year		Approximately 12 months