Safety and Electrical Performances of XFINE Leads (PERSEPOLIS)
Primary Purpose
Bradycardia
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
XFINE leads
Sponsored by
About this trial
This is an interventional other trial for Bradycardia
Eligibility 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
Sites / Locations
- Centre Hospitalier de Cahors
- CHU de Clermont-Ferrand
- Hôpital de la Croix-Rousse
- Clinica Medica - Azienda Ospedaliero Universitaria Careggi
- Ospedale Santa Maria Nuova
- Clinica San Carlo
- Azienda Ospedaliera Santa Maria degli Angeli
- Ospedale Policlinico Casilino
- Ospedale Civile di Vigevano
- Ospedale Civile di Voghera
- Centro Hospitalar do Baixo Vouga, E.P.E.
- Centro Hospitalar do Alto Ave - Hospital da Senhora da Oliveira
- Centro Hospitalar de Leiria - Hospital de Santo André
- Centro Hospitalar Vila Nova de Gaia/Espinho
- Hospital Universitari Joan XXIII
- Hospital Doctor Peset
- Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary
- Kingston Hospital
- Lister Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
JX model
TX model
Arm Description
Subjects implanted with an RA XFINE lead (JX model)
Subjects implanted with an RV XFINE lead (TX model)
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03922386
Brief Title
Safety and Electrical Performances of XFINE Leads
Acronym
PERSEPOLIS
Official Title
ProspEctive Record of Safety and Electrical Performances Of XFINE Leads: an International Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
March 25, 2021 (Actual)
Study Completion Date
July 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MicroPort CRM
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Post market, multicenter, international, prospective, open label, two arms and longitudinal non comparative non randomized study.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
188 (Actual)
8. Arms, Groups, and Interventions
Arm Title
JX model
Arm Type
Other
Arm Description
Subjects implanted with an RA XFINE lead (JX model)
Arm Title
TX model
Arm Type
Other
Arm Description
Subjects implanted with an RV XFINE lead (TX model)
Intervention Type
Device
Intervention Name(s)
XFINE leads
Intervention Description
Pacemaker subjects with at least one XFINE passive lead
Primary Outcome Measure Information:
Title
Freedom from XFINE lead-related complications
Description
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.
Time Frame
at 6 months post implant
Title
Electrical performances confirmation
Description
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.
Time Frame
at 6 months post implant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfredo Bardají, Dr.
Organizational Affiliation
Hospital Universitari Joan XXIII, Tarragona, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de Cahors
City
Cahors
Country
France
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
Country
France
Facility Name
Hôpital de la Croix-Rousse
City
Lyon
Country
France
Facility Name
Clinica Medica - Azienda Ospedaliero Universitaria Careggi
City
Firenze
Country
Italy
Facility Name
Ospedale Santa Maria Nuova
City
Firenze
Country
Italy
Facility Name
Clinica San Carlo
City
Milano
Country
Italy
Facility Name
Azienda Ospedaliera Santa Maria degli Angeli
City
Pordenone
Country
Italy
Facility Name
Ospedale Policlinico Casilino
City
Roma
Country
Italy
Facility Name
Ospedale Civile di Vigevano
City
Vigevano
Country
Italy
Facility Name
Ospedale Civile di Voghera
City
Voghera
Country
Italy
Facility Name
Centro Hospitalar do Baixo Vouga, E.P.E.
City
Aveiro
Country
Portugal
Facility Name
Centro Hospitalar do Alto Ave - Hospital da Senhora da Oliveira
City
Creixomil
Country
Portugal
Facility Name
Centro Hospitalar de Leiria - Hospital de Santo André
City
Leiria
Country
Portugal
Facility Name
Centro Hospitalar Vila Nova de Gaia/Espinho
City
Vila Nova De Gaia
Country
Portugal
Facility Name
Hospital Universitari Joan XXIII
City
Tarragona
Country
Spain
Facility Name
Hospital Doctor Peset
City
Valencia
Country
Spain
Facility Name
Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary
City
Leeds
Country
United Kingdom
Facility Name
Kingston Hospital
City
London
Country
United Kingdom
Facility Name
Lister Hospital
City
Stevenage
Country
United Kingdom
12. IPD Sharing Statement
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Safety and Electrical Performances of XFINE Leads
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