Prediction of Mortality After CIED Implantation (PM-CIED) (PM-CIED)

October 25, 2022 updated by: Yixiu Liang, Shanghai Zhongshan Hospital

Development and Validation of Predictive Models for Mortality After CIED Implantation

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1618

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients who received CRT/ICD implantation for heart failure or high risk of sudden cardiac death (SCD).

Description

Inclusion Criteria:

  • all patients who received implantation of CRT/ICD

Exclusion Criteria:

  • patients who received generator placement of CRT/ICD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 3 years
All-cause death
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Principal Investigator: Yixiu Liang, MD, Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2004

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

May 25, 2022

First Submitted That Met QC Criteria

May 25, 2022

First Posted (Actual)

May 31, 2022

Study Record Updates

Last Update Posted (Actual)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM-CIED

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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