Pacemaker MalfunctionHUCSNCT04320849
Human Use Condition Study- Evaluation of Implanted Leads in Humans
An observational study of Pacemaker Malfunction, run by Duke University at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate different types of leads (wires) that are connected to your pacemaker (an implanted device which assists your heart function) to understand how the shape and motion of your previously implanted lead changes in the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacemaker Malfunction
- How many people
- 117 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Jun 2021to 23 May 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: The study will enroll at least 80 and up to 120 subjects with one of four different specified market-released lead families. The leads are from all four CIED manufacturers participating in this protocol. Approximately 30 leads from each manufacturer's lead family will be required.
Who may be able to join
- Patients with RV leads included in the scope of this study whose system has been implanted for at least 3 calendar months Patients at least 18 years of age and capable of providing informed consent Patients who can physically perform range of arm motion and breath-holding described in the imaging protocol Patients who are willing and able to comply with instruction related to the imaging protocol
Who cannot join
- Planned lead modification Patients with abandoned leads (includes: RV/RA/LV) Patients undergoing second or subsequent pulse generator change Patient has permanent atrial arrhythmias Limited life expectancy or medical condition that would not allow completion of the study Patient is known to be pregnant or breastfeeding at time of consent Limited range of mobility of the implant location arm Patient is unable to climb on and off an examination table unassisted Patients deemed hemodynamically unstable
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
MercyOne Iowa Heart Center
Des Moines, Iowa, 50266
Jackson Heart Clinic
Jackson, Mississippi, 39216
Cedars Sinai Medical Center
Los Angeles, California, 90048
Minneapolis Heart Institute
Saint Paul, Minnesota, 55102
Trinity Clinic
Tyler, Texas, 75701
About this study
Official title: Human Use Condition Study-Fluoroscopic Evaluation of 3D Curvature of Implanted Right Ventricular Leads in Humans
The purpose of this study is to evaluate different types of leads (wires) that are connected to your pacemaker (an implanted device which assists your heart function) to understand how the shape and motion of your previously implanted lead changes in the body.
Read the detailed description
The purpose of this study is to evaluate different types of leads (wires) that are connected to the pacemaker (an implanted device which assists enrolled subject's heart function) to understand how the shape and motion of the previously implanted lead changes in the body.
- Conditions
- Pacemaker Malfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with protocol identified RV Leads | Medtronic model 6935M (Quattro Secure Single Coil Defibrillation Lead) Abbott model LDA 210Q (Optisure Single Coil Defibrillation Lead) Abbott model LDA 220Q (Optisure Dual Coil Defibrillation Lead) Boston Scientific model 4470/4471 (FINELINE II/FINELINE II Sterox); Positive Fixation Biotronik model Solia S (Active Fixation Leads) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With in Vivo Cyclic Mean Curvature of Pacing and Defibrillation Leads in the Extravenous Region Determined During Specified Arm Movements
Measure dynamic in vivo curvature of RV pacing and defibrillator leads in the extravenous and intracardiac anatomy
***In vivo cyclic mean curvature of RV pacing and defibrillation leads in the extravenous region will be determined during specified arm movements. The relationship between lead stiffness and curvature will be evaluated.
Measured: Approximately 1 month
Number of Participants With in Vivo Cyclic Mean Curvature of Pacing and Defibrillation Leads in the Intracardiac Region Determined During Two or More Cardiac Cycles
Measure the relationship between lead bending stiffness and in vivo curvature
***In vivo cyclic mean curvature of RV pacing and defibrillation leads in the intracardiac region will be determined during two or more cardiac cycles. The relationship between lead stiffness and curvature will be evaluated.
Measured: Approximately 1 month
Number of Participants With in Vivo Cyclic Mean Curvature of Pacing and Defibrillation Leads in the Connector Region Determined During Specified Arm Movements
Assess the relationship between subject and implant variables and lead curvature
***In vivo cyclic mean curvature of RV pacing and defibrillation leads in the connector region were determined during specified arm movements. The relationship between lead stiffness and curvature was evaluated.
Measured: Approximately 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start1 Jun 2021
- Primary completion30 Apr 2022
- Study completion23 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pacemaker MalfunctionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott, Medtronic, Biotronik SE & Co. KG, Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Jonathan Piccini, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320849
- Sponsor's protocol ID
- Pro00103284
- Acronym
- HUCS
- Status last verified
- Jan 2024
- First submitted
- 23 Mar 2020
- Last updated
- 19 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Use Condition Study-Fluoroscopic Evaluation of 3D Curvature of Implanted Right Ventricular Leads in Humans
- ClinicalTrials.gov ID
- NCT04320849
- Acronym / sponsor ID
- HUCS / Pro00103284
- Conditions
- Pacemaker Malfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Abbott, Medtronic, Biotronik SE & Co. KG, Boston Scientific Corporation
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 23 May 2022 (actual)
- First posted
- 25 Mar 2020 (actual)
- Results
- Posted 19 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate different types of leads (wires) that are connected to your pacemaker (an implanted device which assists your heart function) to understand how the shape and motion of your previously implanted lead changes in the body.
Detailed description
The purpose of this study is to evaluate different types of leads (wires) that are connected to the pacemaker (an implanted device which assists enrolled subject's heart function) to understand how the shape and motion of the previously implanted lead changes in the body.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with protocol identified RV Leads | – | –Medtronic model 6935M (Quattro Secure Single Coil Defibrillation Lead) Abbott model LDA 210Q (Optisure Single Coil Defibrillation Lead) Abbott model LDA 220Q (Optisure Dual Coil Defibrillation Lead) Boston Scientific model 4470/4471 (FINELINE II/FINELINE II Sterox); Positive Fixation Biotronik model Solia S (Active Fixation Leads) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll at least 80 and up to 120 subjects with one of four different specified market-released lead families. The leads are from all four CIED manufacturers participating in this protocol. Approximately 30 leads from each manufacturer's lead family will be required.
Key inclusion criteria (1 listed)
- Patients with RV leads included in the scope of this study whose system has been implanted for at least 3 calendar months Patients at least 18 years of age and capable of providing informed consent Patients who can physically perform range of arm motion and breath-holding described in the imaging protocol Patients who are willing and able to comply with instruction related to the imaging protocol
Key exclusion criteria (1 listed)
- Planned lead modification Patients with abandoned leads (includes: RV/RA/LV) Patients undergoing second or subsequent pulse generator change Patient has permanent atrial arrhythmias Limited life expectancy or medical condition that would not allow completion of the study Patient is known to be pregnant or breastfeeding at time of consent Limited range of mobility of the implant location arm Patient is unable to climb on and off an examination table unassisted Patients deemed hemodynamically unstable
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
Number of Participants With in Vivo Cyclic Mean Curvature of Pacing and Defibrillation Leads in the Extravenous Region Determined During Specified Arm Movements
Time frame: Approximately 1 month
Measure dynamic in vivo curvature of RV pacing and defibrillator leads in the extravenous and intracardiac anatomy ***In vivo cyclic mean curvature of RV pacing and defibrillation leads in the extravenous region will be determined during specified arm movements. The relationship between lead stiffness and curvature will be evaluated.
Number of Participants With in Vivo Cyclic Mean Curvature of Pacing and Defibrillation Leads in the Intracardiac Region Determined During Two or More Cardiac Cycles
Time frame: Approximately 1 month
Measure the relationship between lead bending stiffness and in vivo curvature ***In vivo cyclic mean curvature of RV pacing and defibrillation leads in the intracardiac region will be determined during two or more cardiac cycles. The relationship between lead stiffness and curvature will be evaluated.
Number of Participants With in Vivo Cyclic Mean Curvature of Pacing and Defibrillation Leads in the Connector Region Determined During Specified Arm Movements
Time frame: Approximately 1 month
Assess the relationship between subject and implant variables and lead curvature ***In vivo cyclic mean curvature of RV pacing and defibrillation leads in the connector region were determined during specified arm movements. The relationship between lead stiffness and curvature was evaluated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jonathan Piccini, MD principal investigator
Duke University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pacemaker Malfunction, run by Duke University at 5 sites in United States.
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 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
Yes. Results are posted in the registry (first posted 19 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With in Vivo Cyclic Mean Curvature of Pacing and Defibrillation Leads in the Extravenous Region Determined During Specified Arm Movements (time frame: Approximately 1 month). The study lists 3 primary outcomes in all. 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 19 Jan 2024.