Heart Failure, SystolicPM-CIEDNCT05396313
Prediction of Mortality After CIED Implantation (PM-CIED)
An observational study of Heart Failure, Systolic and Sudden Cardiac Death, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The study aims to develop and validate predictive models for the mortality of patients receiving CIED (including CRT and ICD) implantation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure, Systolic, Sudden Cardiac Death
- What is being tested?
- CRT/ICD
- Type of treatment
- Medical device
- How many people
- 1,618 participants
- Where
- 1 siteChina
- Study dates
- Aug 2004to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients who received CRT/ICD implantation for heart failure or high risk of sudden cardiac death (SCD).
Who may be able to join
- all patients who received implantation of CRT/ICD
Who cannot join
- patients who received generator placement of CRT/ICD
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital
Shanghai
Yixiu Liang, MD, +862164041990, liang.yixiu@zs-hospital.sh.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure, Systolic, Sudden Cardiac Death
- Being tested
- CRT/ICD
- Medical subject headings
- Heart Failure, Systolic, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT/ICDDevice
The patients received implantation of CRT/ICD.
| Study group | Role | What they receive |
|---|---|---|
| Zhongshan Hospital cohort | Patients receiving CIED implantation at Zhongshan Hospital Receives: Device: CRT/ICD | |
| Fuwai Hospital cohort | Patients receiving CIED implantation at Fuwai Hospital Receives: Device: CRT/ICD | |
| Shanghai Chest Hospital cohort | Patients receiving CIED implantation at Shanghai Chest Hospital Receives: Device: CRT/ICD |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
All-cause death
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study startAug 2004
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, SystolicStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,618 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yixiu Liang, Shanghai Zhongshan Hospital
- Investigators
- Yixiu Liang, MD, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396313
- Sponsor's protocol ID
- PM-CIED
- Acronym
- PM-CIED
- Status last verified
- Oct 2022
- First submitted
- 25 May 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pan L, Liu X, Zhu L, Yu Z, Wang J, Li X, Zhang W, Li R, Wang Z, Lu H, Yang S, Li P, Su Y, Hua W, Liang Y. Machine Learning-Based Prognostic Models for Mortality in Patients Receiving Implantable Cardioverter Defibrillators. Pacing Clin Electrophysiol. 2025 Aug;48(8):906-916. doi: 10.1111/pace.70008. Epub 2025 Jul 8.
PubMed 40625105
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Predictive Models for Mortality After CIED Implantation
- ClinicalTrials.gov ID
- NCT05396313
- Acronym / sponsor ID
- PM-CIED / PM-CIED
- Conditions
- Heart Failure, Systolic, Sudden Cardiac Death
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,618 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Aug 2004 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to develop and validate predictive models for the mortality of patients receiving CIED (including CRT and ICD) implantation.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Zhongshan Hospital cohort | – | Device: CRT/ICDPatients receiving CIED implantation at Zhongshan Hospital |
| Fuwai Hospital cohort | – | Device: CRT/ICDPatients receiving CIED implantation at Fuwai Hospital |
| Shanghai Chest Hospital cohort | – | Device: CRT/ICDPatients receiving CIED implantation at Shanghai Chest Hospital |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients who received CRT/ICD implantation for heart failure or high risk of sudden cardiac death (SCD).
Key inclusion criteria (1 listed)
- all patients who received implantation of CRT/ICD
Key exclusion criteria (1 listed)
- patients who received generator placement of CRT/ICD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRT/ICDThe patients received implantation of CRT/ICD. | Device | Fuwai Hospital cohort, Shanghai Chest Hospital cohort, Zhongshan Hospital cohort |
Primary outcome
All-cause mortality
Time frame: 3 years
All-cause death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Derived from this study: PubMed 40625105Pan L, Liu X, Zhu L, Yu Z, Wang J, Li X, Zhang W, Li R, Wang Z, Lu H, Yang S, Li P, Su Y, Hua W, Liang Y. Machine Learning-Based Prognostic Models for Mortality in Patients Receiving Implantable Cardioverter Defibrillators. Pacing Clin Electrophysiol. 2025 Aug;48(8):906-916. doi: 10.1111/pace.70008. Epub 2025 Jul 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yixiu Liang, MD principal investigator
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, Systolic and Sudden Cardiac Death, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yixiu Liang, MD (+862164041990, liang.yixiu@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05396313, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.