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Clinical outcomes comparison between His-Purkinje pacing and right ventricular pacing in patients with bradycardia: a Bi-directional Cohort Study

Clinical outcomes comparison between His-Purkinje pacing and right ventricular pacing in patients with bradycardia: a Bi-directional Cohort Study

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100043296
Enrollment
Unknown
Registered
2021-02-09
Start date
2021-02-09
Completion date
Unknown
Last updated
2021-06-07

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

Conditions

Bradycardia

Interventions

HPP group:His bundle pacing or left bundle branch area pacing
RVP group:right ventricular septal/apical pacing

Sponsors

Fuwai Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: a. Consecutive patients who received pacemaker implantation due to bradycardia according to the current guideline (Class I and IIa recommendation); b. left ventricular ejection fraction(LVEF) over 50% c. Consent form signed; d. Aged 18-90 years old.

Exclusion criteria

Exclusion criteria: a. Implanted implantable cardioverter-defibrillator; b. Received biventricular pacing; c. Previous tricuspid annuloplasty history; d. Pregnancy; e. Unwilling to be followed-up.

Design outcomes

Primary

MeasureTime frame
Rate of composite outcomes, including all-cause death, hospitalization for heart failure, and an upgrade to cardiac resynchronization therapy due to pacing induced heart failure;

Secondary

MeasureTime frame
The rate of composite outcomes of all-cause death and/or hospitalization for heart failure;The rate of composite outcomes of hospitalization for heart failure and/or an upgrade to cardiac resynchronization therapy due to pacing induced heart failure. ;The rate of composite outcomes of LVEF <50%, and/or an increase in LVESV =15% during follow-up as compared with the value at randomization;The value of LVEF and LVESV assessed by echocardiography ;The immediate success rate of the pacing procedure;Rate of procedure and Device related complications;Rate of atrial high-rate episodes recorded by the pacemaker;Rate of tricuspid regurgitation during the follow up;Pacing characteristics;Electrophysiological parameters;Echocardiographic measurements;

Countries

China

Contacts

Public ContactXiaohan Fan

Fuwai Hospital, Chinese Academy of Medical Sciences

fanxiaohan@fuwaihospital.org+86 13811421067

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 14, 2026