Driveline InfectionNCT06878456
Incidence and Management of Driveline Infection in Patients with CH-VAD
An observational study of Driveline Infection, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
The goal of this observational study is to learn about the incidence of the Driveline Infection of a novel full-magnetically levitated left ventricular assist device with a new design of driveline. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Driveline Infection
- How many people
- 181 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 31 Oct 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 181 consecutive AHF patients who received CH-VAD implantation between June 2017 and October 2024 in China, with no patients excluded.
Who may be able to join
- Patients who received CH-VAD implantations for advanced heart failure between June 2017 and October 2024.
Who cannot join
- No specific exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence and Management of Driveline Infection in Patients with CH-VAD: a Multi-centre, Observational Study
The goal of this observational study is to learn about the incidence of the Driveline Infection of a novel full-magnetically levitated left ventricular assist device with a new design of driveline.
The main question it aims to answer is : The incidence of DLI in Chinese CH-VAD implanted advanced heart failure patients and the main risk factors.
CH-VAD has been approved in China for the treatment of patients with advanced heart failure.
Read the detailed description
- Background: Driveline infection (DLI) is a major complication of left ventricular assist devices (LVADs) and is associated with significant morbidity and mortality. The CH-VAD is a novel, fully magnetically levitated LVAD designed with an ultra-thin and highly flexible driveline, which may reduce the risk of DLI compared to traditional LVADs. Previous research has indicated that driveline design features, such as diameter and flexibility, are key risk factors for DLI. This study aims to assess the incidence, management, outcomes and risk factors of DLI in CH-VAD patients.Rationale: Understanding the incidence and management of DLI in patients receiving the CH-VAD can provide valuable insights into the effectiveness of this device in reducing infection rates. A better understanding of these factors will help refine clinical practices and inform device development to minimize infection risks.
- Study Design
- Design Type: Retrospective, observational, multicenter study.
- Study Population: 181 consecutive patients who received CH-VAD implantations between June 2017 and October 2024 at 9 centers in China.
- Primary Objective: To evaluate the incidence of DLI in CH-VAD patients.
- Secondary Objectives: To identify factors associated with DLI, assess the management strategies, evaluate patient outcomes, and detect risk factors for DLI.
- Study Population
- Inclusion Criteria:
- Patients who received CH-VAD implantations for advanced heart failure (AHF) between June 2017 and October 2024.
- Exclusion Criteria:
- No specific exclusion criteria.
- Data Collection
- Demographic and clinical characteristics from medical records, including age, sex, comorbidities, heart failure etiologies, INTERMACS profiles.
- Surgical details, including device type, duration of support, and concomitant surgeries.
- Infection prevention measures, including the use of prophylactic antibiotics, skin decolonization procedures, driveline fixation sutures, etc.
- Driveline care measures, including dressing change frequency, types of disinfectants, dressing types, fixation measures, etc.
- Incidence and management of DLI, including diagnostic methods, treatment approaches, and outcomes.
- Information on the pathogens involved in DLI and complications such as recurrent infections, driveline revisions, and mortality.
- Statistical Analysis
- Descriptive statistics will be used to summarize patient demographics, DLI incidence, and outcomes.
- Univariate and multivariate regression analyses will be conducted to identify potential risk factors for DLI.
- Time-to-event analysis will be performed using Kaplan-Meier curves to evaluate freedom from DLI over time.
- Statistical significance will be set at p<0.05.
- Expected Outcomes and Significance
- Primary Outcome: Incidence of DLI in patients with CH-VAD.
- Secondary Outcomes: Risk factors associated with DLI, the impact of DLI on patient outcomes, and the effectiveness of different management strategies.
- The findings from this study could provide valuable insights into the clinical management of CH-VAD patients and inform future advancements in LVAD design to minimize DLI.
- Timeline
- Study Period: June 2017 to October 2024 (Data collection period).
- Data Analysis Period: November 2024 to January 2025.
- Results Publication: Expected by March 2025.
- Conditions
- Driveline Infection
- Keywords
- advanced heart failure, left ventricular assist device, driveline infection
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of driveline infection in CH-VAD patients in China
Measured: Reported data includes baseline, peri-operative data and data at study completion. Outcome measurement is performed at the study completion, an average of 1.03 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 Jun 2017
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
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 Driveline InfectionStudies of the same condition, open and under way.
- 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
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Collaborators
- Wuhan Asia Heart Hospital, Sichuan Provincial People's Hospital, Zhejiang Provincial People's Hospital, Ruijin Hospital, Shanghai Zhongshan Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, First Affiliated Hospital Xi'an Jiaotong University
- Responsible party
- Principal investigator, Shengshou Hu, China National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878456
- Sponsor's protocol ID
- China-NCCD
- Status last verified
- Mar 2025
- First submitted
- 13 Jan 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang X, Zhou X, Chen H, Zhang H, Zhang Y, Cui Y, Huang K, Hua Z, Yan Y, Zhou M, Zhao Q, Sun X, Wang C, Ge Z, Dong A, Hu S. Low Driveline Infection Rates in Patients With a Novel Fully Magnetically Levitated Ventricular Assist Device. Eur J Cardiothorac Surg. 2025 Dec 1;67(12):ezaf365. doi: 10.1093/ejcts/ezaf365.
PubMed 41137667
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Management of Driveline Infection in Patients with CH-VAD: a Multi-centre, Observational Study
- ClinicalTrials.gov ID
- NCT06878456
- Acronym / sponsor ID
- China-NCCD
- Conditions
- Driveline Infection
- Keywords
- advanced heart failure, left ventricular assist device, driveline infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Wuhan Asia Heart Hospital, Sichuan Provincial People's Hospital, Zhejiang Provincial People's Hospital, Ruijin Hospital, Shanghai Zhongshan Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, First Affiliated Hospital Xi'an Jiaotong University
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 17 Mar 2025 (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 goal of this observational study is to learn about the incidence of the Driveline Infection of a novel full-magnetically levitated left ventricular assist device with a new design of driveline.
The main question it aims to answer is : The incidence of DLI in Chinese CH-VAD implanted advanced heart failure patients and the main risk factors.
CH-VAD has been approved in China for the treatment of patients with advanced heart failure.
Detailed description
- Background: Driveline infection (DLI) is a major complication of left ventricular assist devices (LVADs) and is associated with significant morbidity and mortality. The CH-VAD is a novel, fully magnetically levitated LVAD designed with an ultra-thin and highly flexible driveline, which may reduce the risk of DLI compared to traditional LVADs. Previous research has indicated that driveline design features, such as diameter and flexibility, are key risk factors for DLI. This study aims to assess the incidence, management, outcomes and risk factors of DLI in CH-VAD patients.Rationale: Understanding the incidence and management of DLI in patients receiving the CH-VAD can provide valuable insights into the effectiveness of this device in reducing infection rates. A better understanding of these factors will help refine clinical practices and inform device development to minimize infection risks.
- Study Design
- Design Type: Retrospective, observational, multicenter study.
- Study Population: 181 consecutive patients who received CH-VAD implantations between June 2017 and October 2024 at 9 centers in China.
- Primary Objective: To evaluate the incidence of DLI in CH-VAD patients.
- Secondary Objectives: To identify factors associated with DLI, assess the management strategies, evaluate patient outcomes, and detect risk factors for DLI.
- Study Population
- Inclusion Criteria:
- Patients who received CH-VAD implantations for advanced heart failure (AHF) between June 2017 and October 2024.
- Exclusion Criteria:
- No specific exclusion criteria.
- Data Collection
- Demographic and clinical characteristics from medical records, including age, sex, comorbidities, heart failure etiologies, INTERMACS profiles.
- Surgical details, including device type, duration of support, and concomitant surgeries.
- Infection prevention measures, including the use of prophylactic antibiotics, skin decolonization procedures, driveline fixation sutures, etc.
- Driveline care measures, including dressing change frequency, types of disinfectants, dressing types, fixation measures, etc.
- Incidence and management of DLI, including diagnostic methods, treatment approaches, and outcomes.
- Information on the pathogens involved in DLI and complications such as recurrent infections, driveline revisions, and mortality.
- Statistical Analysis
- Descriptive statistics will be used to summarize patient demographics, DLI incidence, and outcomes.
- Univariate and multivariate regression analyses will be conducted to identify potential risk factors for DLI.
- Time-to-event analysis will be performed using Kaplan-Meier curves to evaluate freedom from DLI over time.
- Statistical significance will be set at p<0.05.
- Expected Outcomes and Significance
- Primary Outcome: Incidence of DLI in patients with CH-VAD.
- Secondary Outcomes: Risk factors associated with DLI, the impact of DLI on patient outcomes, and the effectiveness of different management strategies.
- The findings from this study could provide valuable insights into the clinical management of CH-VAD patients and inform future advancements in LVAD design to minimize DLI.
- Timeline
- Study Period: June 2017 to October 2024 (Data collection period).
- Data Analysis Period: November 2024 to January 2025.
- Results Publication: Expected by March 2025.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 181 consecutive AHF patients who received CH-VAD implantation between June 2017 and October 2024 in China, with no patients excluded.
Key inclusion criteria (1 listed)
- Patients who received CH-VAD implantations for advanced heart failure between June 2017 and October 2024.
Key exclusion criteria (1 listed)
- No specific exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the incidence of driveline infection in CH-VAD patients in China
Time frame: Reported data includes baseline, peri-operative data and data at study completion. Outcome measurement is performed at the study completion, an average of 1.03 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Derived from this study: PubMed 41137667Wang X, Zhou X, Chen H, Zhang H, Zhang Y, Cui Y, Huang K, Hua Z, Yan Y, Zhou M, Zhao Q, Sun X, Wang C, Ge Z, Dong A, Hu S. Low Driveline Infection Rates in Patients With a Novel Fully Magnetically Levitated Ventricular Assist Device. Eur J Cardiothorac Surg. 2025 Dec 1;67(12):ezaf365. doi: 10.1093/ejcts/ezaf365.
- Individual participant dataSharing planned: No
Related trials for Driveline Infection
Active, not recruitingObservational study
Postoperative Infections and Immune Profiles in Patients Undergoing LVAD Implantation
Infection, Driveline Heart-assisted Device Related Infection
Enrolling by invitationObservational study
Non-invasive Detection of Driveline Infections in Patients with a Left Ventricular Assist Device
LVAD (Left Ventricular Assist Device) Driveline Infection
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Driveline Infection, run by China National Center for Cardiovascular Diseases 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: finished, as of the sponsor's last update on 17 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of driveline infection in CH-VAD patients in China (time frame: Reported data includes baseline, peri-operative data and data at study completion. Outcome measurement is performed at the study completion, an average of 1.03 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 NCT06878456, 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 17 Mar 2025.