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Efficacy and safety of his bundle pacing in clinical application

Efficacy and safety of his bundle pacing in clinical application

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-16009767
Enrollment
Unknown
Registered
2016-11-07
Start date
2016-12-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Chronic heart failure with bradycardiac arrhythmia

Interventions

Sponsors

Shanghai Chest Hospital, Shanghai Jiao Tong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Signing the informed consent of the patient and indicating the date of signing; Patients with relatively stable residential location can finish follow-up during the clinical study; Aged at least 18 years old; Patients with cardiac pacing indications; NYHA cardiac function grade II-IV; LVEF=45%.

Exclusion criteria

Exclusion criteria: QRS>120ms (except right bundle branch block); Life expectancy is less than 3 years; Patients with right ventricular mechanical valve; Heart transplant patients or patients waiting for heart transplantation; Patients with heart valve disease; Women of childbearing age who have been pregnant or are pregnant at the time of the study; Patients with severe renal insufficiency (Cre >2.5mg/dl or > 275umol/LGFR =30 ml/min/1.72m2); Patients with severe hepatic insufficiency; Patients with severe anemia; Patients have been registered other clinical studies which may affect the purpose of this study.

Design outcomes

Primary

MeasureTime frame
Any one of right ventricular leads, left ventricular leads, or his bundle leads failed in implantation;The conduction block was found to occur in the descending pathway of the bundle conduction during pacemaker implantation;Pacemakers need to be removed for other reasons; or pacemaker and electrode wire systems need to be repaired;Right ventricular pacing, left ventricular pacing or his bundle pacing threshold is greater than 5 volts during follow-up;Completing 18 months follow-up;Patient death;

Countries

China

Contacts

Public ContactRuogu Li

Shanghai Chest Hospital, Shanghai Jiao Tong University

lrgchest@yahoo.com+86 13564565961

Outcome results

None listed

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