Clinical trial NCT01856491: Safety and Performance Study of the RELIANCE 4-Front Passive Fixation Lead
Official title: RELIANCE 4-FRONT™ Passive Fixation Defibrillation Lead Post Market Clinical Follow-Up (PMCF) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tachycardia
Ventricular Fibrillation
Ventricular Flutter
Keywords: RELIANCE 4-FRONT
Implantable Cardioverter Defibrillator (ICD)
Cardiac Resynchronization Therapy - Defibrillator (CRT-D)
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2013-05-17
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT™ Passive Fixation Defibrillation Leads.

Detailed description: The RELIANCE 4-FRONT Passive Fixation Defibrillation Lead Post Market Clinical Follow-Up Study is a prospective, non-randomized, multi-center, single-group, post market clinical study to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT passive fixation defibrillation leads.

A total of 167 patients (including 10 % attrition) are required to evaluate the Primary Endpoint.

Up to 10 Investigational centers located in Europe and Israel. Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.

Lead-related complications associated with the RELIANCE 4-FRONT passive fixation lead will count toward this endpoint.

Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.

Lead-related complications associated with the RELIANCE 4-FRONT passive fixation lead will count toward this endpoint.

* Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant
* Pacing Threshold at 0.5 ms pulse width at 3 Months Post-Implant
* Sensed Amplitude at 3 Months Post-Implant
* Pacing Impedance at 3 Months Post-Implant All endpoints will be assessed for the RELIANCE 4-FRONT passive fixation lead.

Clinic visits will occur at:

* Enrollment Visit (no later than 30 days prior to implant procedure)
* Implant Procedure (Day 0; all future follow ups based on this date)
* Pre-Discharge Clinic Visit (3 - 72 hours post-implant)
* One Month Clinic Visit (30±7 days)
* 3 Month Clinic Visit (91 ± 21 days)
* 6 Month Clinic Visit (180 ± 30 days)
* 12 Month Clinic Visit (365 ± 45 days)
* 18 Month Clinic Visit (545± 45 days)
* 24 Month Clinic Visit (730 ± 45 days) The study will be considered completed after all subjects have completed the 24 Month follow-up and study completion is anticipated in 2015. Primary endpoint completion is anticipated after all subjects have completed the 3 Month follow-up visit. All study required visits will be completed during clinic visits.

Hypotheses testing in the RELIANCE 4-FRONT passive fixation PMCF Study will use standard statistical methodology as specified more in detail in the protocol.

Eligibility criteria: Inclusion Criteria:

* Willing and capable of providing informed consent
* Has an indication for implantation of a single or dual chamber ICD or CRT-D system in their respective geography
* Subjects planned to be implanted with the RELIANCE 4-FRONT Passive Fixation Lead
* Willing and capable of participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol
* Age 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

* Known or suspected sensitivity to Dexamethasone Acetate (DXA)
* Mechanical tricuspid heart valve
* Subject is enrolled in any other concurrent study without prior written approval from Boston Scientific (BSC), with the exception of local mandatory governmental registries and observational studies/registries that are not in conflict and do not affect the following:
* Schedule of procedures for the RELIANCE 4-Front Study (i.e. should not cause additional or missed visits);
* RELIANCE 4-Front Study outcome (i.e. involve medications that could affect the heart rate of the subject);
* Conduct of the RELIANCE 4-Front Study per Good Clinical Practice (GCP)/ International Organization for Standardization (ISO) 14155:2011/ 21 CFR 812/ local regulations
* Currently on the active heart transplant list
* Documented life expectancy of less than 12 months
* Women of childbearing potential who are or might be pregnant at the time of study enrollment (method of assessment upon physician discretion)
* Currently requiring chronic dialysis

Primary outcomes:
measure: Complication Free Rate
timeFrame: 3-months
Secondary outcomes:
measure: Complication Free Rate
timeFrame: 3 months through 15 months post implant
Other outcomes:
measure: Pacing Threshold at 0.5 ms Pulse Width
timeFrame: 3 Months Post-Implant
measure: Complication Free Rate
timeFrame: 3 months through 24 months post implant
measure: Sensed Amplitude
timeFrame: 3 Months Post-Implant
measure: Pacing Impedance
timeFrame: 3 Months Post-Implant
Locations:
city: Berlin
country: Germany
facility: German Heart Center
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
city: Petah-Tikva
country: Israel
facility: Beilinson Medical Center
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
city: Campobasso
country: Italy
facility: Fondazione di Ricerca e Cura 'Giovanni Paolo II
city: Lecco
country: Italy
facility: Ospedale Alessandro Manzoni
city: Naples
country: Italy
facility: Clinica Mediterranea
city: Naples
country: Italy
facility: Ospedale Buon Consiglio
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Pozzuoli
country: Italy
facility: Osp. Civile S. Maria Delle Grazie
city: Rome
country: Italy
facility: Ospedale San Pietro Fatebenefratelli
Study officials:
affiliation: University Hospital Pisa, Italy
name: Maria Grazia Bongiorni, MD
role: PRINCIPAL_INVESTIGATOR
References: