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Study of Home Monitoring system Safety and Efficacy in Cardiac Implantable ElecTronic Device (CIED) implanted patients (SUMMIT) – Pacemaker and CRT

Study of Home Monitoring system Safety and Efficacy in Cardiac Implantable ElecTronic Device (CIED) implanted patients (SUMMIT) – Pacemaker and CRT

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONRC-13003695
Enrollment
Unknown
Registered
2013-10-11
Start date
2013-10-08
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

Sick sinus syndrome, AV block

Interventions

experimental group:Cardiac Implantable ElecTronic Device with Home Mo
control group:Cardiac Implantable ElecTronic Device with Home Mo

Sponsors

Zhongshan Hospital Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 95 Years

Inclusion criteria

Inclusion criteria: 1) Meet the indications of dual chamber pacemaker and CRTP implantation; 2) Sinus rhythm at enrollment; 3) Without notable structural heart disease(for dual-chamber pacemaker patients); 4) Willing to comply with the program protocol; 5) Patient has provided informed consent; 6) Patients >18 years of age.

Exclusion criteria

Exclusion criteria: 1) Previous atrial fibrillation history; 2) Notable structural heart disease, EF=45 mm or/and LVEDD>=55mm(for dual-chamber pacemaker patients); 3) Anti-coagulation therapy; 4) Dual anti-platelet therapy; 5) Class I or class III anti arrhythmic drug therapy; 6) Contraindications to antithrombotic therapy; 7) Participated in other clinical trials which may influence the outcome of this study; 8) Life expectancy of <2 years.

Design outcomes

Primary

MeasureTime frame
composite endpoint(Stroke Heart failure and death;

Secondary

MeasureTime frame
AF Episodes Duration and AF burden;

Countries

China

Contacts

Public ContactWang Jing
jing.wang@biotronik.com+86 010-65223851

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 25, 2026