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Study of Home Monitoring system Safety and Efficacy in Cardiac Implantable Electronic Device (CIED) implanted patients (SUMMIT) – ICD and CRTD

Study of Home Monitoring system Safety and Efficacy in Cardiac Implantable Electronic Device (CIED) implanted patients (SUMMIT) – ICD and CRTD

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONRC-13003694
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

Ventricular Tachycardia?Ventricular Fibrillation

Interventions

experimental group:ICD
control group:ICD

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 ICD, CRTD implantation, not limited to primary or secondary prevention; 2. Implanted BIOTRONIK ICD or CRTD with immediate successful implantation; 3. Patient has provided informed consent; 4. Able to complete the follow-up according to protocol.

Exclusion criteria

Exclusion criteria: 1. Life expectancy of <2 years; 2. Participated in other clinical trials which may influence the outcome of this study.

Design outcomes

Primary

MeasureTime frame
Proportion of patients experiencing VF episodes;Proportion of patients experiencing VT episodes;Proportion of patients experiencing ICD shock;

Secondary

MeasureTime frame
Numbers of ATP therapy;Numbers of successful ATP therapy;Changes in cardiac function (NYHA BNP Echo:LVEDD, LVEF, BNP);SSAE (Death cardiovascular hospitalization);

Countries

China

Contacts

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

Outcome results

None listed

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