High Intensity His Bundle Pacing in Heart Failure Patients With Narrow QRS Outcome Study

NCT05491655 | Recruiting

• 1 other identifier: MGH_003
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac Resynchronization Therapy (CRT) decreases heart failure hospitalizations and mortality and increases left ventricular Ejection Fraction (EF) in patients with dilated cardiomyopathy, left bundle branch block and QRS duration \>130msec. His bundle pacing has a similar effect in this category of patients. However, CRT is not beneficial in heart failure (HF) patients with narrow QRS. His-bundle pacing delivers physiological ventricular activation and has been shown to improve acute hemodynamic function in patients with heart failure, a prolonged PR interval, and either a narrow QRS or RBBB through AV delay optimization. We observed an acute hemodynamic effect during application of higher pacing output (3.5 Volts/1 msec) in HF patients with dilated or ischemic cardiomyopathy and narrow QRS independently of the paced QRS duration or AV delay shortening. This is a single-center, prospective randomized single-blinded study, recruiting a sub-population of patients with heart failure (dilated or ischemic cardiomyopathy, EF\<50%, narrow QRS (\<110 msec), in optimal medical treatment who have an indication for ICD.

Conditions

His Bundle Pacing; Heart Failure; Cardiomyopathies; Cardiac Conduction System

Keywords

His bundle pacing; conduction system pacing; Heart failure; Cardiomyopathy; narrow QRS; Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• Change in left ventricular ejection fraction

  change in left ventricular ejection fraction measured by 2D echo at 6 months compared to baseline

  Baseline pre-intervention, randomisation and 6 months post randomisation

Secondary Outcomes (3)

• Changes in B-type Natriuretic Peptide (BNP)

  Baseline pre-intervention, randomisation and 6 months post randomisation

• Changes in Quality of Life (QOL) Scores

  Baseline pre-intervention,1 and 6 months post randomisation

• Changes in arrhythmia burden

  1 month and 6 months post randomization.

Study Arms (2)

High intensity His bundle pacing

EXPERIMENTAL

After implantation of the device there will be a 1-month run-in period that the device will be programmed to deliver His bundle pacing therapy during this period at 3.5V/1msec. After one month these patients will continue to receive active pacing treatment with 3.5V/1msec.

Device: High Intensity His Bundle pacing

Back up only ventricular pacing

SHAM COMPARATOR

After implantation of the device there will be a 1-month run-in period that the device will be programmed to deliver His bundle pacing therapy during this period at 2V/1msec. After one month these patients will receive back up only pacing (pacemaker programmed to VVI 30 bpm or AAI(R)-DDD(R) 50bpm) for 6 months.

Device: High Intensity His Bundle pacing

Interventions

High Intensity His Bundle pacing DEVICE

All patients will be implanted with an Implantable cardioverter defibrillator (ICD) and an ICD lead in the right ventricle (either RV apex or RV septum). In all patients a pacing lead will be positioned in the right atrium (typically the right atrial appendage). All patients will have a pacemaker lead positioned on the His bundle to obtain direct His-bundle capture.

Back up only ventricular pacing; High intensity His bundle pacing

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 or above
• Ventricular Ejection Fraction (EF) \< 50%; BNP needs to be ≥250ng/L or N Terminal-pro BNP≥600ng/L for patients with EF 36-50% and they should have an ICD indication
• New York Heart Association (NYHA) class I-IV
• Narrow QRS duration (≤110ms) on 12 lead ECG

You may not qualify if:

• Other serious medical condition with life expectancy of less than 1 year
• Lack of capacity to consent
• Pregnancy
• Previous aortic valve surgery

Sponsors & Collaborators

• Miulli General Hospital: lead

Study Sites (1)

Miulli General Hospital

Acquaviva delle Fonti, Bari, 70021, Italy

RECRUITING

Related Publications (5)

• Grigorios E Katsouras, Stavros Stavrakis, Beneficial effects of high output His bundle pacing in patients with heart failure and narrow QRS, Heart Rhythm, Vol 20, Issue 5, Supplement, S479-S480

  BACKGROUND

• Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, Carson P, DiCarlo L, DeMets D, White BG, DeVries DW, Feldman AM; Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004 May 20;350(21):2140-50. doi: 10.1056/NEJMoa032423.

  PMID: 15152059 BACKGROUND

• Upadhyay GA, Vijayaraman P, Nayak HM, Verma N, Dandamudi G, Sharma PS, Saleem M, Mandrola J, Genovese D, Tung R; His-SYNC Investigators. His Corrective Pacing or Biventricular Pacing for Cardiac Resynchronization in Heart Failure. J Am Coll Cardiol. 2019 Jul 9;74(1):157-159. doi: 10.1016/j.jacc.2019.04.026. Epub 2019 May 9. No abstract available.

  PMID: 31078637 BACKGROUND

• Cleland JG, Abraham WT, Linde C, Gold MR, Young JB, Claude Daubert J, Sherfesee L, Wells GA, Tang AS. An individual patient meta-analysis of five randomized trials assessing the effects of cardiac resynchronization therapy on morbidity and mortality in patients with symptomatic heart failure. Eur Heart J. 2013 Dec;34(46):3547-56. doi: 10.1093/eurheartj/eht290. Epub 2013 Jul 29.

  PMID: 23900696 BACKGROUND

• Whinnett ZI, Shun-Shin MJ, Tanner M, Foley P, Chandrasekaran B, Moore P, Adhya S, Qureshi N, Muthumala A, Lane R, Rinaldi A, Agarwal S, Leyva F, Behar J, Bassi S, Ng A, Scott P, Prasad R, Swinburn J, Tomson J, Sethi A, Shah J, Lim PB, Kyriacou A, Thomas D, Chuen J, Kamdar R, Kanagaratnam P, Mariveles M, Burden L, March K, Howard JP, Arnold A, Vijayaraman P, Stegemann B, Johnson N, Falaschetti E, Francis DP, Cleland JGF, Keene D. Effects of haemodynamically atrio-ventricular optimized His bundle pacing on heart failure symptoms and exercise capacity: the His Optimized Pacing Evaluated for Heart Failure (HOPE-HF) randomized, double-blind, cross-over trial. Eur J Heart Fail. 2023 Feb;25(2):274-283. doi: 10.1002/ejhf.2736.

  PMID: 36404397 BACKGROUND

MeSH Terms

Conditions

Arrhythmias, Cardiac; Heart Failure; Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Grigorios Katsouras, MD, MSc

CONTACT

0803054219; g.katsouras@miulli.it

Pietro Guida

CONTACT

0803054029; p.guida@miulli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Subjects will be blinded to treatment arm. Echocardiographic evaluation will be performed by study physician blinded to lead placement
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist, Principal Investigator

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 8, 2022
• Study Start: March 29, 2023
• Primary Completion: February 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)