Pacemaker ComplicationSTERILENCT05390216
Impact of Partial Capsule Decortication on Device-related Infection in Patients Receiving Cardiac Implantable Electronic Device Replacement
A study testing Partial capsule decortication in people with Pacemaker Complication and Infections, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Increasing number of cardiac implantable electronic devices (CIEDs) have been implanted in the worldwide every year, which is accompanied by the growing number of CIED-related infection, especially in patients with CIED replacement. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pacemaker Complication, Infections
- What is being tested?
- Partial capsule decortication
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,016 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2022to 31 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient is at least 18 years of age
- Patient is planned to undergo at least one of the following procedures:
- Patient has existing CIED (pacemaker, or CRT-P, or ICD, or CRT-D) and is undergoing pulse generator replacement or upgrade with a new generator. b) Patients planned to have leads added, or extracted and added for upgrades.
- Patient is willing to sign and date informed consent
Who cannot join
- History of CIED-related infection
- Open the pocket for any reason within the last one year
- Any evidence indicating active infection
- Requirement of long term vascular access for any reason
- Expected survival time is less than one year
- Patients who were pregnant or breastfeeding
- Participation in another study that may confound the results of this study
- Patient is unable to comply with scheduled follow up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Partial Capsule Decortication on Device-related Infection in Patients Receiving Cardiac Implantable Electronic Device Replacement: a Multicenter Randomized Controlled Trial
Increasing number of cardiac implantable electronic devices (CIEDs) have been implanted in the worldwide every year, which is accompanied by the growing number of CIED-related infection, especially in patients with CIED replacement. This multicenter, prospective, single-blinded, randomized controlled trial is to confirm the impact of partial capsule decortication on device-related infection in patients receiving CIED replacement.
- Conditions
- Pacemaker Complication, Infections
- Being tested
- Partial capsule decortication
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial capsule decorticationProcedure or surgery
The anterior wall of the capsule was removed during the operation.
| Study group | Role | What they receive |
|---|---|---|
| Partial capsule decortication | Experimental | Not described Receives: Procedure: Partial capsule decortication |
| Without partial capsule decortication | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of major CIED-related infection
Infections that resulted in CIED system removal, an invasive CIED procedure (e.g., pocket revision without removal), treatment with long-term antibiotic therapy (if the patient was not a candidate for system removal) with infection recurrence after discontinuation of antibiotic therapy, or death.
Measured: Within the first year after the operation
Secondary outcomes (5)
Rate of minor CIED-related infection
Infections that do not meet the definition criteria of major CIED infection.
Measured: Within the first year after the operation
Rate of all CIED-related infection
All infections that related to CIED operation.
Measured: Within the first year after the operation
Rate of pocket hematoma
Palpable swelling with fluctuance that extended beyond the device margin but without evidence of infection.
Measured: Within the first year after the operation
Rate of device dysfunction
All the dysfunction of the generators and leads (including abnormal changes of pacing threshold, sensing, impedance, etc.).
Measured: Within the first year after the operation
All-cause mortality
Death regardless of the causes.
Measured: Within the first year after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start5 Jun 2022
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacemaker ComplicationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,016 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390216
- Sponsor's protocol ID
- 12901
- Acronym
- STERILE
- Status last verified
- Jun 2024
- First submitted
- 18 May 2022
- Last updated
- 24 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Partial Capsule Decortication on Device-related Infection in Patients Receiving Cardiac Implantable Electronic Device Replacement: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05390216
- Acronym / sponsor ID
- STERILE / 12901
- Conditions
- Pacemaker Complication, Infections
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,016 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 5 Jun 2022 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 25 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.
Increasing number of cardiac implantable electronic devices (CIEDs) have been implanted in the worldwide every year, which is accompanied by the growing number of CIED-related infection, especially in patients with CIED replacement. This multicenter, prospective, single-blinded, randomized controlled trial is to confirm the impact of partial capsule decortication on device-related infection in patients receiving CIED replacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial capsule decortication | Experimental | Procedure: Partial capsule decortication |
| Without partial capsule decortication | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is at least 18 years of age
- Patient is planned to undergo at least one of the following procedures:
- Patient is willing to sign and date informed consent
Key exclusion criteria (8 listed)
- History of CIED-related infection
- Open the pocket for any reason within the last one year
- Any evidence indicating active infection
- Requirement of long term vascular access for any reason
- Expected survival time is less than one year
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 |
|---|---|---|
| Partial capsule decorticationThe anterior wall of the capsule was removed during the operation. | Procedure or surgery | Partial capsule decortication |
Primary outcome
Rate of major CIED-related infection
Time frame: Within the first year after the operation
Infections that resulted in CIED system removal, an invasive CIED procedure (e.g., pocket revision without removal), treatment with long-term antibiotic therapy (if the patient was not a candidate for system removal) with infection recurrence after discontinuation of antibiotic therapy, or death.
5 secondary outcomes
Rate of minor CIED-related infection
Time frame: Within the first year after the operation
Rate of all CIED-related infection
Time frame: Within the first year after the operation
Rate of pocket hematoma
Time frame: Within the first year after the operation
Rate of device dysfunction
Time frame: Within the first year after the operation
All-cause mortality
Time frame: Within the first year after the operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: No
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Effects of Short-Term Arm Sling Use After Cardiac Implantable Electronic Device Placement
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Ultrasound-Guided PECS II Block for Permanent Pacemaker Implantation
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Not yet recruitingObservational study
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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.
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?
A study testing Partial capsule decortication in people with Pacemaker Complication and Infections, 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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 24 Jun 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Rate of major CIED-related infection (time frame: Within the first year after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2024.