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Zero-Fluoroscopy Cardiac Pacing System Implantation Guided by Intracardiac Echocardiography: A Feasibility Study

Zero-Fluoroscopy Cardiac Pacing System Implantation Guided by Intracardiac Echocardiography: A Feasibility Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600121348
Enrollment
Unknown
Registered
2026-03-30
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Slow-type arrhythmia

Interventions

Exploratory Clinical Study (Phase 1):None
Verification Clinical Study (Phase 2):None

Sponsors

Zhongda Hospital Affiliated to Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. age >=18 years old 2. Patients who met the indications for pacemaker implantation according to current guidelines and were preparing for the first transvenous implantation of a permanent pacemaker in the chest 3. It was consistent with the application of intracardiac echocardiography. 4. Patients provided written informed consent and were expected to complete all scheduled follow-up visits and examinations as required by the protocol

Exclusion criteria

Exclusion criteria: 1. Other active or discarded cardiac implants were present in patients 2. Patients had undergone cardiac-related surgery (including ventriculotomy, atriotomy, atrial septal occlusion, or left atrial appendage occlusion) or valve-related surgery 3. Patients had known contraindications, including sepsis, severe coagulation abnormalities, intracardiac thrombosis, severe angina or heart failure, deep vein thrombosis, severe peripheral vascular disease, hemodynamic instability, or a history of malignancy 4. Women who plan to become pregnant, pregnant, or breastfeeding 5. Participating in other interventional clinical investigators 6. The investigator judged that the subjects had poor compliance, were unable to complete the study as required, and were otherwise not suitable for participating in this clinical study

Design outcomes

Primary

MeasureTime frame
Pacing threshold;perceived amplitude;pacing impedance;

Secondary

MeasureTime frame
Occurrence of adverse events and serious adverse events related to intracardiac ultrasound imaging and/or pacing system implantation;

Countries

China

Contacts

Public ContactLong Chen

Zhongda Hospital Affiliated to Southeast University

longchen.crown@163.com+86 138 5163 8480

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026