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出境医 / 临床实验 / Safety and Electrical Performances of XFINE Leads (PERSEPOLIS)
Safety and Electrical Performances of XFINE Leads (PERSEPOLIS)
Study Description
Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bradycardia | Device: XFINE leads | Not Applicable |
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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 188 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Post market, multicenter, international, prospective, open label, two arms and longitudinal non comparative non randomized study. |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | ProspEctive Record of Safety and Electrical Performances Of XFINE Leads: an International Study |
| Actual Study Start Date : | September 9, 2019 |
| Actual Primary Completion Date : | March 25, 2021 |
| Estimated Study Completion Date : | July 15, 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
JX model
Subjects implanted with an RA XFINE lead (JX model)
|
Device: XFINE leads
Pacemaker subjects with at least one XFINE passive lead
|
|
TX model
Subjects implanted with an RV XFINE lead (TX model)
|
Device: XFINE leads
Pacemaker subjects with at least one XFINE passive lead
|
Outcome Measures
Primary Outcome Measures :
- 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.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
- 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
Contacts and Locations
Locations
Show 19 study locations
Sponsors and Collaborators
MicroPort CRM
Investigators
| Principal Investigator: | Alfredo Bardají, Dr. | Hospital Universitari Joan XXIII, Tarragona, Spain |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 15, 2019 | ||||
| First Posted Date ICMJE | April 22, 2019 | ||||
| Last Update Posted Date | April 19, 2021 | ||||
| Actual Study Start Date ICMJE | September 9, 2019 | ||||
| Actual Primary Completion Date | March 25, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Safety and Electrical Performances of XFINE Leads | ||||
| Official Title ICMJE | ProspEctive Record of Safety and Electrical Performances Of XFINE Leads: an International Study | ||||
| Brief 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. | ||||
| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Intervention Model Description: Post market, multicenter, international, prospective, open label, two arms and longitudinal non comparative non randomized study. Masking: None (Open Label)Primary Purpose: Other |
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| Condition ICMJE | Bradycardia | ||||
| Intervention ICMJE | Device: XFINE leads
Pacemaker subjects with at least one XFINE passive lead
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Actual Enrollment ICMJE |
188 | ||||
| Original Estimated Enrollment ICMJE |
228 | ||||
| Estimated Study Completion Date ICMJE | July 15, 2021 | ||||
| Actual Primary Completion Date | March 25, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | France, Italy, Portugal, Spain, United Kingdom | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03922386 | ||||
| Other Study ID Numbers ICMJE | LBFX05 - PERSEPOLIS | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | MicroPort CRM | ||||
| Study Sponsor ICMJE | MicroPort CRM | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | MicroPort CRM | ||||
| Verification Date | April 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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