Evaluation of Electrical and Hemodynamic Effects of Different Pacing Strategies in CRT Candidates

NCT07032064 | Completed

• 1 other identifier: CPP-Electro-Hemo
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Heart failure patients with delayed electrical activation of the heart often benefit from cardiac resynchronization therapy (CRT). However, traditional CRT using biventricular pacing is not effective in all patients. This study aims to evaluate the acute effects of pacing at different sites within the heart's conduction system-including His bundle pacing, deep septal pacing, left ventricular septal pacing, non-selective left bundle branch pacing, and selective left bundle branch pacing. We will assess how these pacing strategies improve electrical synchrony and heart function by analyzing ECG parameters, such as QRS duration and QRS area, and measuring hemodynamic response using left ventricular pressure changes. The goal is to identify which pacing site provides the best improvement in heart performance. The study includes patients with left bundle branch block or intraventricular conduction delay, reduced heart function (ejection fraction \<35%), and prolonged QRS duration (\>150 ms). This research may help improve the effectiveness of pacing therapy in heart failure patients who are not responding well to current CRT methods.

Conditions

Heart Failure; CRT and/or ICD

Keywords

Cardiac resynchronization therapy;; Cardiac physiologic pacing；; Heart failure; Left bundle branch area pacing; Electrical resynchronization; Hemodynamic assessment

Outcome Measures

Primary Outcomes (3)

• QRSd

  QRSd was measured from the onset to the end of the QRS complex

  within 30 minutes per patient

• QRSa

  QRSa was computed as the sum of the QRS area across three orthogonal vectorcardiographic leads reconstructed using the Kors transformation matrices

  within 30 minutes per patient

• Hemodynamic Evaluation

  Continuous non-invasive blood pressure was monitored using a Finometer device

  within 30 minutes per patient

Study Arms (1)

Evaluation of five pacing strategies in a Single-Arm CRT candidate cohort

EXPERIMENTAL

All enrolled patients will undergo sequential pacing at five ventricular sites during a single procedure: His bundle pacing (HBP), deep septal pacing (DSP), left ventricular septal pacing (LVSP), non-selective left bundle branch pacing (NS-LBBP), and selective left bundle branch pacing (SLBBP). Each pacing mode will be tested under identical physiological conditions in the same individual, and electrical and hemodynamic parameters will be recorded for comparative analysis. The order of pacing may be randomized or standardized according to protocol.

Procedure: Sequential ventricular pacing at five sites

Interventions

Sequential ventricular pacing at five sites PROCEDURE

This intervention involves sequential temporary pacing at five distinct ventricular sites within the same patient during a single electrophysiological study. The pacing sites include:His bundle pacing (HBP),Deep septal pacing (DSP),Left ventricular septal pacing (LVSP),Non-selective left bundle branch pacing (NS-LBBP),Selective left bundle branch pacing (SLBBP). Each pacing modality is tested under identical hemodynamic and electrophysiological conditions using a fixed output and AV delay. Electrical parameters and acute hemodynamic responses are recorded for each site. The study uses a within-subject crossover design, allowing direct intra-individual comparison of different pacing strategies in patients meeting standard CRT indications. No long-term device implantation is involved during this phase of the study.

Evaluation of five pacing strategies in a Single-Arm CRT candidate cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• NYHA class I to ambulatory IV despite optimized medical therapy for ≥3 months, LVEF ≤35%, and sinus rhythm with LBBB. LBBB was defined as QRS duration ≥130 ms, QS or rS in lead V1, broad/notched R waves in leads I, aVL, V5-V6, and absence of q waves in V5-V6

You may not qualify if:

• second- or third-degree AV block, frequent PVCs, moderate-to-severe aortic stenosis, LV thrombus, or significant peripheral vascular disease

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Yixiu Liang, M.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Physician

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 22, 2025
• Study Start: June 3, 2024
• Primary Completion: May 20, 2025
• Study Completion: May 20, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: starting 6 months after publication
• Access Criteria: IPD could be requested by contacting the corresponding author via email after publication.

Locations

CN (1)