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A multicenter, prospective, cohort clinical study on the safety and effectiveness of subthreshold automatic threshold management function in ventricular pacing in the left bundle branch region.

A multicenter, prospective, cohort clinical study on the safety and effectiveness of subthreshold automatic threshold management function in ventricular pacing in the left bundle branch region.

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500095635
Enrollment
Unknown
Registered
2025-01-09
Start date
2025-01-09
Completion date
Unknown
Last updated
2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrioventricular block/Atrial fibrillation with slow ventricular rate

Interventions

Group with normal cardiac function:None
Group with impaired cardiac function:None

Sponsors

The First Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria: Participants in this clinical study must meet all of the following criteria: 1) 18 years old=40%; 4) NYHA cardiac function classification: Grade I-III; 5) Expected ventricular pacing ratio >20%; 6) The subject or his/her guardian can understand the purpose of the study, voluntarily participate in the study, comply with the visit plan and provide written information Consent form.

Exclusion criteria

Exclusion criteria: 2. Exclusion criteria: Subjects will be excluded from the study if they meet any of the following exclusion criteria: 1) Patients with contraindications to any implantable pacemaker; 2) Patients with implantable cardiac defibrillator; 3) Patients with unstable angina pectoris, acute myocardial infarction, CABG and PCI within 3 months before surgery; 4) The patient underwent any heart valve surgery or any other heart surgery after mechanical tricuspid valve replacement, or within three months; 5) Patients with valvular heart disease who have indications of surgery or intervention plan to undergo interventional or surgical treatment; 6) ventricular septal hypertrophy (end-diastolic thickness exceeding 15mm), ventricular septal defect after treatment and complex congenital heart disease; 7) Pacemaker replacement, pacemaker upgrade, pacemaker bag infection re-implantation; 8) Within 3 months, they have been enrolled in other clinical studies that may affect the purpose of this study; 9) Mentally incapacitated or unable to understand the investigator's requirements, such as unable to express, read and understand the questions in the subject's subjective questionnaire specified in the research protocol; 10) The investigator determined that the patient had other conditions that were not suitable for this test

Design outcomes

Primary

MeasureTime frame
Accuracy of VCM functional measurement values;

Secondary

MeasureTime frame
Admission rate/death rate of postoperative heart failure;Incidence of postoperative atrial high frequency events;Changes of electrical parameters of postoperative pacemaker;life quality score;NYHA classification;Changes of related parameters of color Doppler ultrasound;

Countries

China

Contacts

Public ContactXia Yunlong

The First Affiliated Hospital of Dalian Medical University

yunlong_xia@126.com+86 180 9887 5555

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026