Prediction of Mortality After CIED Implantation (PM-CIED)

Sponsor

Shanghai Zhongshan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05396313

Collaborator

(none)

1,618

Enrollment

Location

216

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aims to develop and validate predictive models for the mortality of patients receiving CIED (including CRT and ICD) implantation.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure, Systolic Sudden Cardiac Death	Device: CRT/ICD

Detailed Description

The study aims to develop and validate predictive models for the mortality of patients receiving cardiovascular implantable electronic devices (CIED) [including cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillator (ICD)] implantation, with traditional statistical analysis and machine learning algorithms.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1618 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Development and Validation of Predictive Models for Mortality After CIED Implantation

Actual Study Start Date :

Aug 1, 2004

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Zhongshan Hospital cohort Patients receiving CIED implantation at Zhongshan Hospital	Device: CRT/ICD The patients received implantation of CRT/ICD.
Fuwai Hospital cohort Patients receiving CIED implantation at Fuwai Hospital	Device: CRT/ICD The patients received implantation of CRT/ICD.
Shanghai Chest Hospital cohort Patients receiving CIED implantation at Shanghai Chest Hospital	Device: CRT/ICD The patients received implantation of CRT/ICD.

Arm

Intervention/Treatment

Zhongshan Hospital cohort

Patients receiving CIED implantation at Zhongshan Hospital

Device: CRT/ICD

The patients received implantation of CRT/ICD.

Fuwai Hospital cohort

Patients receiving CIED implantation at Fuwai Hospital

Device: CRT/ICD

The patients received implantation of CRT/ICD.

Shanghai Chest Hospital cohort

Patients receiving CIED implantation at Shanghai Chest Hospital

Device: CRT/ICD

The patients received implantation of CRT/ICD.

Outcome Measures

Primary Outcome Measures

All-cause mortality [3 years]
All-cause death

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

all patients who received implantation of CRT/ICD

Exclusion Criteria:

patients who received generator placement of CRT/ICD

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan Hospital	Shanghai		China

Sponsors and Collaborators

Shanghai Zhongshan Hospital

Investigators

Principal Investigator: Yixiu Liang, MD, Shanghai Zhongshan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yixiu Liang, Doctor, Shanghai Zhongshan Hospital

ClinicalTrials.gov Identifier:

NCT05396313

Other Study ID Numbers:

PM-CIED

First Posted:

May 31, 2022

Last Update Posted:

May 31, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Death, Sudden, Cardiac

Heart Failure, Systolic

Death

Study Results

No Results Posted as of May 31, 2022