Actively Recruiting

Age: 18Years - 100Years
All Genders
ID04931550

Clinical Study of Impact of Different Pacing Site in Patients

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2023-01-31

600

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the long-term effectiveness and safety of cardiac pacing at different sites in patients with bradyarrhythmias and heart failure. The study aims to compare the benefits and drawbacks of pacing from various locations within the heart, such as the right atrial appendage, atrial septum, right atrial wall, His bundle, left bundle branch area, right ventricular apex, outflow tract, and left ventricular pacing via the coronary vein. This observational study addresses a gap in knowledge about which pacing sites provide the best outcomes in daily medical practice. Participants will receive pacemaker implantation with the pacing site chosen based on their individual condition. The study focuses on monitoring the effects of pacing at these different sites over time without assigning specific treatments randomly. There is no mention of separate study phases or extension periods. During the study, patients will be followed up for up to 60 months to track a composite outcome that includes cardiovascular death, myocardial infarction, and stroke events. Researchers will observe participants' health status through regular visits and data collection related to these cardiovascular events. The study is led by the Second Affiliated Hospital, School of Medicine, Zhejiang University, and aims to gather real-world evidence on pacing site impact.

CONDITIONS

Brief Title

Clinical Study of Impact of Different Pacing Site in Patients

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who received pacemaker implantation in the Second Hospital of Zhejiang Medical University by Pan Xiaohong and other surgeons.
  • Patients who have the ability to understand the test and can cooperate with investigators.
Not Eligible

You will not qualify if you...

  • Patients who are unable to understand or unwilling to fill in informed consent forms or follow visitors.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - 1 day

Participants undergo pacemaker implantation with pacing sites chosen based on their condition.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 60 months

Participants are monitored for cardiovascular outcomes including death, myocardial infarction, and stroke events.

Trial Site Locations

Total: 1 location

1

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China, 310009

Actively Recruiting

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Research Team

X

Xiaohong Pan

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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