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Cardiac Pacing

His-Bundle vs Biventricular Pacing for Heart Failure (HIS-CRT Trial)

N/A
Recruiting
Led By Valentina Kutyifa, MD, PhD
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
NYHA class III-IV a HF, LVEF ≤ 35%, and QRS duration ≥ 150 ms (IIa)
Optimal medical therapy for heart failure by current guidelines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

HIS-CRT Trial Summary

This trialwill compare two treatments for heart failure with RBBB to see which one works best.

Who is the study for?
This trial is for heart failure patients with right bundle branch block who meet specific criteria: they have certain levels of heart function and symptoms, are at least 18 years old, and follow optimal medical therapy. It's not for those with left bundle branch block, other ECG issues, or a life expectancy under one year.Check my eligibility
What is being tested?
The study compares two types of pacemaker implantations in heart failure patients: His-bundle pacing (His-CRT) versus traditional cardiac resynchronization therapy (BIV-CRT). The goal is to see which method works better for correcting the heartbeat.See study design
What are the potential side effects?
While the description doesn't list side effects explicitly, typical risks may include infection at the implant site, bleeding or bruising, lead displacement requiring repositioning, and rarely device malfunction.

HIS-CRT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart function is severely reduced, and I have a specific heart rhythm pattern.
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I am receiving the best current treatment for heart failure.
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My heart function is severely reduced, with specific heart rhythm characteristics.
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My heart's pumping ability is weak, and I have moderate heart failure symptoms.

HIS-CRT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Left Ventricular Ejection Fraction at 6 months with His-CRT vs. BIV-CRT, in heart failure patients with Right bundle branch block (RBBB)
Secondary outcome measures
Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in ECG biomarkers
Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in NT-proBNP
Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in echocardiographic left ventricular end-diastolic volume (LVEDV)
+1 more
Other outcome measures
Ascertain the mechanism of benefit on ventricular depolarization (QRS duration) over time, at 6 months, 12 months, and 24 months.
Heart failure (HF) or death events

HIS-CRT Trial Design

2Treatment groups
Active Control
Group I: BIV-CRT implantationActive Control1 Intervention
BIV-CRT implantation includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular lead, and an epicardial left ventricular lead implanted in a branch of the coronary sinus.
Group II: His-CRT implantationActive Control1 Intervention
His-CRT implantation includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular lead, and an endocardial His-bundle pacing leads directly pacing the intrinsic conduction system.

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,847 Previous Clinical Trials
47,818,536 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,706 Previous Clinical Trials
7,507,793 Total Patients Enrolled
University of RochesterLead Sponsor
841 Previous Clinical Trials
533,597 Total Patients Enrolled

Media Library

BIV-CRT (Cardiac Pacing) Clinical Trial Eligibility Overview. Trial Name: NCT05265520 — N/A
His Bundle Pacing Research Study Groups: BIV-CRT implantation, His-CRT implantation
His Bundle Pacing Clinical Trial 2023: BIV-CRT Highlights & Side Effects. Trial Name: NCT05265520 — N/A
BIV-CRT (Cardiac Pacing) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05265520 — N/A

Frequently Asked Questions

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

Are new participants being accepted for this investigation?

"According to information disseminated on clinicaltrials.gov, this medical trail is actively recruiting patients with the initial advertisement posted on December 2nd 2022 and revised in its entirety on December 8th of that same year."

Answered by AI

How many patients are currently being evaluated through this clinical trial?

"Affirmative. Clinicaltrials.gov details indicate that this research project, which was intially posted on December 2nd 2022, is actively searching for subjects to take part in the trial. In total, 120 people must be found at 3 different sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
His-Bundle Corrective Pacing in Heart Failure
Valentina Kutyifa 2022. "His-Bundle Corrective Pacing in Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05265520.
All > Heart Failure
~63 spots leftby Jan 2026
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