Safety and Electrical Performances of XFINE Leads

NCT03922386 | Completed

• 1 other identifier: LBFX05 - PERSEPOLIS
• Study Type: interventional
• Target: 188
• Locations: 5 countries
• Sites: 19

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.

Conditions

Bradycardia

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  at 6 months post implant

Study Arms (2)

JX model

OTHER

Subjects implanted with an RA XFINE lead (JX model)

Device: XFINE leads

TX model

OTHER

Subjects implanted with an RV XFINE lead (TX model)

Device: XFINE leads

Interventions

XFINE leads DEVICE

Pacemaker subjects with at least one XFINE passive lead

JX model; TX model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MicroPort CRM: lead

Study Sites (19)

Centre Hospitalier de Cahors

Cahors, France

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Location

Hôpital de la Croix-Rousse

Lyon, France

Location

Clinica Medica - Azienda Ospedaliero Universitaria Careggi

Florence, Italy

Location

Ospedale Santa Maria Nuova

Florence, Italy

Location

Clinica San Carlo

Milan, Italy

Location

Azienda Ospedaliera Santa Maria degli Angeli

Pordenone, Italy

Location

Ospedale Policlinico Casilino

Roma, Italy

Location

Ospedale Civile di Vigevano

Vigevano, Italy

Location

Ospedale Civile di Voghera

Voghera, Italy

Location

Centro Hospitalar do Baixo Vouga, E.P.E.

Aveiro, Portugal

Location

Centro Hospitalar do Alto Ave - Hospital da Senhora da Oliveira

Creixomil, Portugal

Location

Centro Hospitalar de Leiria - Hospital de Santo André

Leiria, Portugal

Location

Centro Hospitalar Vila Nova de Gaia/Espinho

Vila Nova de Gaia, Portugal

Location

Hospital Universitari Joan XXIII

Tarragona, Spain

Location

Hospital Doctor Peset

Valencia, Spain

Location

Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary

Leeds, United Kingdom

Location

Kingston Hospital

London, United Kingdom

Location

Lister Hospital

Stevenage, United Kingdom

Location

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alfredo Bardají, Dr.

  Hospital Universitari Joan XXIII, Tarragona, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Post market, multicenter, international, prospective, open label, two arms and longitudinal non comparative non randomized study.

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 22, 2019
• Study Start: September 9, 2019
• Primary Completion: March 25, 2021
• Study Completion: July 23, 2021
• Last Updated: April 6, 2023

Record last verified: 2023-04

Locations

IT (7); FR (3); ES (2); PT (4); GB (3)