BradycardiaPERSEPOLISNCT03922386
Safety and Electrical Performances of XFINE Leads
A study testing XFINE leads in people with Bradycardia, run by MicroPort CRM at 19 sites in 5 countries.
Trial summary
The purpose of the study is to confirm the safety and the electrical performances of the XFINE passive pacing leads, for both right ventricular (RV) straight models and right atrial (RA) J-shape models, up to 12 months follow-up post implant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia
- What is being tested?
- XFINE leads
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 19 sitesin 5 countries
- Study dates
- 9 Sep 2019to 23 Jul 2021
- Phase
- Interventional
- 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
Who may be able to join
- Any subject newly implanted according to the most recent guidelines from the European Society of Cardiology (ESC) for less than10 days with:
- a Single Chamber (SR) or a Dual Chamber (DR) pacemaker from Microport CRM S.r.l.
- any right atrial and/or right ventricular XFINE lead
- Have reviewed, signed and dated the informed consent
Who cannot join
- Included in another clinical study that could confound the results of this study such as studies involving intra-cardiac device
- Contraindication to a maximum single dose of 310 µg Dexamethasone Sodium Phosphate (DSP)
- Tricuspid valvular disease or tricuspid replacement heart valve (mechanical or tissue) only for subject with DR pacemaker
- Active myocarditis, pocket and/or lead infection
- Age less than 18 years old or under guardianship or kept in detention
- Life expectancy less than 1 year
- Known pregnancy, women breastfeeding or in childbearing age without an adequate contraceptive method
- Be unavailable for the scheduled follow-up associated with this clinical study or refusal to cooperate
Trial locations and contacts
19 sites in 5 countries.
19 sites in 5 countries
Italy7 sites
Clinica Medica - Azienda Ospedaliero Universitaria Careggi
Florence
Ospedale Santa Maria Nuova
Florence
Clinica San Carlo
Milan
Azienda Ospedaliera Santa Maria degli Angeli
Pordenone
Ospedale Policlinico Casilino
Roma
Ospedale Civile di Vigevano
Vigevano
Ospedale Civile di Voghera
Voghera
Portugal4 sites
Centro Hospitalar do Baixo Vouga, E.P.E.
Aveiro
Centro Hospitalar do Alto Ave - Hospital da Senhora da Oliveira
Creixomil
Centro Hospitalar de Leiria - Hospital de Santo André
Leiria
Centro Hospitalar Vila Nova de Gaia/Espinho
Vila Nova de Gaia
France3 sites
Centre Hospitalier de Cahors
Cahors
CHU de Clermont-Ferrand
Clermont-Ferrand
Hôpital de la Croix-Rousse
Lyon
United Kingdom3 sites
Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary
Leeds
Kingston Hospital
London
Lister Hospital
Stevenage
Spain2 sites
Hospital Universitari Joan XXIII
Tarragona
Hospital Doctor Peset
Valencia
About this study
Official title: ProspEctive Record of Safety and Electrical Performances Of XFINE Leads: an International Study
The purpose of the study is to confirm the safety and the electrical performances of the XFINE passive pacing leads, for both right ventricular (RV) straight models and right atrial (RA) J-shape models, up to 12 months follow-up post implant.
Read the detailed description
All subjects will be followed until 12 months follow-up post implant.
At each follow-up visits (3, 6 and 12 months), electrical performances will be measured and safety will be monitored during the whole study duration.
- Conditions
- Bradycardia
- Being tested
- XFINE leads
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XFINE leadsDevice
Pacemaker subjects with at least one XFINE passive lead
| Study group | Role | What they receive |
|---|---|---|
| JX model | Other | Subjects implanted with an RA XFINE lead (JX model) Receives: Device: XFINE leads |
| TX model | Other | Subjects implanted with an RV XFINE lead (TX model) Receives: Device: XFINE leads |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from XFINE lead-related complications
This endpoint will confirm the freedom from XFINE Lead-Related Complications (LRC) up to the 6 months post implant follow-up. The anticipated complication-free rate is 0.95, and will be compared against an a priori performance goal of 0.85.
An XFINE Lead-Related Complication (LRC) is defined as any XFINE (RA and/or RV) lead-related Serious Adverse Device Effect (SADE) that resulted in subject death or required an additional invasive intervention (excluding re-programming) and occurred within 6 months post implant. This endpoint will be assessed independently for each lead model.
Measured: at 6 months post implant
Electrical performances confirmation
This endpoint will characterize the XFINE lead performances in ensuring adequate Pacing Capture Thresholds (PCT) through 6 months post implant follow-up. The values assessed in this analysis are the PCT measured at 0.50 ms (or less) pulse width at 6 months follow-up visit. The PCT measured at 6 months will be compared against an a priori performance goal of 1.0V/0.5 ms, assuming an expected pacing threshold at 6 months of 0.8V/0.5 ms with a standard deviation of 0.5V. This endpoint will be assessed independently for each lead model.
Measured: at 6 months post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start9 Sep 2019
- Primary completion25 Mar 2021
- Study completion23 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Post market, multicenter, international, prospective, open label, two arms and longitudinal non comparative non randomized study.
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicroPort CRM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alfredo Bardají, Dr., Principal investigator, Hospital Universitari Joan XXIII, Tarragona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922386
- Sponsor's protocol ID
- LBFX05 - PERSEPOLIS
- Acronym
- PERSEPOLIS
- Status last verified
- Apr 2023
- First submitted
- 15 Apr 2019
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProspEctive Record of Safety and Electrical Performances Of XFINE Leads: an International Study
- ClinicalTrials.gov ID
- NCT03922386
- Acronym / sponsor ID
- PERSEPOLIS / LBFX05 - PERSEPOLIS
- Conditions
- Bradycardia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- MicroPort CRMIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 23 Jul 2021 (actual)
- First posted
- 22 Apr 2019 (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 purpose of the study is to confirm the safety and the electrical performances of the XFINE passive pacing leads, for both right ventricular (RV) straight models and right atrial (RA) J-shape models, up to 12 months follow-up post implant.
Detailed description
All subjects will be followed until 12 months follow-up post implant.
At each follow-up visits (3, 6 and 12 months), electrical performances will be measured and safety will be monitored during the whole study duration.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Post market, multicenter, international, prospective, open label, two arms and longitudinal non comparative non randomized study.
| Arm | Type | Receives |
|---|---|---|
| JX model | Other | Device: XFINE leadsSubjects implanted with an RA XFINE lead (JX model) |
| TX model | Other | Device: XFINE leadsSubjects implanted with an RV XFINE lead (TX model) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any subject newly implanted according to the most recent guidelines from the European Society of Cardiology (ESC) for less than10 days with:
- Have reviewed, signed and dated the informed consent
Key exclusion criteria (8 listed)
- Included in another clinical study that could confound the results of this study such as studies involving intra-cardiac device
- Contraindication to a maximum single dose of 310 µg Dexamethasone Sodium Phosphate (DSP)
- Tricuspid valvular disease or tricuspid replacement heart valve (mechanical or tissue) only for subject with DR pacemaker
- Active myocarditis, pocket and/or lead infection
- Age less than 18 years old or under guardianship or kept in detention
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 |
|---|---|---|
| XFINE leadsPacemaker subjects with at least one XFINE passive lead | Device | JX model, TX model |
Primary outcome
Freedom from XFINE lead-related complications
Time frame: at 6 months post implant
This endpoint will confirm the freedom from XFINE Lead-Related Complications (LRC) up to the 6 months post implant follow-up. The anticipated complication-free rate is 0.95, and will be compared against an a priori performance goal of 0.85. An XFINE Lead-Related Complication (LRC) is defined as any XFINE (RA and/or RV) lead-related Serious Adverse Device Effect (SADE) that resulted in subject death or required an additional invasive intervention (excluding re-programming) and occurred within 6 months post implant. This endpoint will be assessed independently for each lead model.
Electrical performances confirmation
Time frame: at 6 months post implant
This endpoint will characterize the XFINE lead performances in ensuring adequate Pacing Capture Thresholds (PCT) through 6 months post implant follow-up. The values assessed in this analysis are the PCT measured at 0.50 ms (or less) pulse width at 6 months follow-up visit. The PCT measured at 6 months will be compared against an a priori performance goal of 1.0V/0.5 ms, assuming an expected pacing threshold at 6 months of 0.8V/0.5 ms with a standard deviation of 0.5V. This endpoint will be assessed independently for each lead model.
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 6 Apr 2023.
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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.
Alfredo Bardají, Dr. principal investigator
Hospital Universitari Joan XXIII, Tarragona, Spain
19 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XFINE leads in people with Bradycardia, run by MicroPort CRM at 19 sites in 5 countries.
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: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Italy, Portugal, France, United Kingdom, Spain. 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?
Freedom from XFINE lead-related complications (time frame: at 6 months post implant). The study lists 2 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 6 Apr 2023.