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Cardiac Pacing

His Bundle vs Biventricular Pacing for Heart Failure

N/A

Recruiting

Led By Mihail G Chelu, MD, PhD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are optimized on HF guideline directed medical therapy according to current HF published guidelines

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5.5 years

Awards & highlights

Study Summary

This trial tests how different pacemakers affect quality of life, physical activity, heart failure hospitalizations, and mortality in those with heart failure.

Who is the study for?

This trial is for adults over 18 with heart failure and left ventricular dysfunction (LVEF≤50%), who are on standard heart failure meds, have a wide QRS (≥130 ms), or need/already have >40% right ventricular pacing. It's not for those with short life expectancy, certain preexisting conditions, recent heart attacks or procedures, reversible cardiomyopathies, severe valve disease, or women who are pregnant.Check my eligibility

What is being tested?

The study compares His bundle or Left bundle branch pacing against standard biventricular pacing in improving quality of life and reducing hospitalizations and mortality in patients with systolic dysfunction and wide QRS complex. It also assesses the safety regarding device complications like lead dislodgement and infection.See study design

What are the potential side effects?

Potential side effects may include issues related to the pacemaker such as local infection at the implant site, lead dislodgement requiring re-intervention, bleeding or bruising around the area where the device was implanted.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My heart failure treatment follows the latest guidelines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

A combined clinical endpoint of all-cause mortality and hospitalization for heart failure

Secondary outcome measures

Assess change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) at 12 months

Cardiovascular hospitalization at 5.5 years

Change in NYHA Classification at 12 months

+5 more

Other outcome measures

Appropriate ICD therapy for ventricular arrhythmias

Change in Left Ventricular Ejection Fraction (LVEF) at 12 months

Change in NT-proBNP at 12 months

+1 more

Trial Design

2Treatment groups

Active Control

Group I: Biventricular Pacing (BiVP)Active Control1 Intervention

Patients with LVEF≤35% at entry will receive a BiV defibrillator which includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular ICD lead, and and an epicardial left ventricular lead implanted in a branch of the coronary sinus. Patients with LVEF 36-50% at entry will receive BiV pacemaker which includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular pacing lead, and and an epicardial left ventricular lead implanted in a branch of the coronary sinus.

Group II: His/Left Bundle Branch Pacing (His/LBBP)Active Control1 Intervention

Patients with LVEF≤35% at entry will receive a His/LBB defibrillator which includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular ICD lead, and an endocardial His-bundle or left bundle branch pacing lead directly pacing the intrinsic conduction system. Patients with LVEF 36-50% at entry will receive His/LBB pacemaker which includes implantation of two leads, an endocardial right atrial lead, and an endocardial His-bundle or left bundle branch pacing lead directly pacing the intrinsic conduction system.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,000,276 Total Patients Enrolled

13 Trials studying Heart Failure

1,382 Patients Enrolled for Heart Failure

Patient-Centered Outcomes Research InstituteOTHER

551 Previous Clinical Trials

29,995,322 Total Patients Enrolled

15 Trials studying Heart Failure

232,793 Patients Enrolled for Heart Failure

University of UtahOTHER

1,100 Previous Clinical Trials

1,776,765 Total Patients Enrolled

17 Trials studying Heart Failure

1,143 Patients Enrolled for Heart Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this study ongoing?

"Indeed, this medical trial is seeking additional participants. The research was posted on September 13th of 2023 and recently modified on November 19th the same year."

Answered by AI

What is the uppermost limit of participants for this experiment?

"Absolutely. According to clinicaltrials.gov, this research has been recruiting since September 13th 2023 and was last updated on November 19th 2023. The current goal is for 2136 patients to be enrolled between 4 different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Left vs Left Randomized Clinical Trial

Mihail Gabriel Chelu 2023. "Left vs Left Randomized Clinical Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05650658.

All > Cardiomyopathy