CompletedNCT01856491Updated Apr 30, 2019Results posted

Safety and Performance Study of the RELIANCE 4-Front Passive Fixation Lead

An interventional study of RELIANCE 4-FRONT™ Passive Fixation lead implantation in Tachycardia, Ventricular Fibrillation and Ventricular Flutter, sponsored by Boston Scientific Corporation. Completed at 11 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-30.

Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 167
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Tachycardia
Ventricular Fibrillation
Ventricular Flutter

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Keywords

RELIANCE 4-FRONT
Implantable Cardioverter Defibrillator (ICD)
Cardiac Resynchronization Therapy - Defibrillator (CRT-D)

In context

Tachycardia

623 studies on the registry are indexed under Tachycardia; 81 are open to participants now.

This study's enrollment of 167 is above the median of 64 across 379 interventional studies indexed under Tachycardia.

Browse Tachycardia studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 167 participants (actual)

Study arms

Other
RELIANCE 4-FRONT™ Passive Fixation
Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead
Device: RELIANCE 4-FRONT™ Passive Fixation lead implantation

Interventions

DeviceRELIANCE 4-FRONT™ Passive Fixation lead implantation
Implantation of transvenous defibrillation lead with passive fixation mechanism.

What researchers measure

Primary outcomes

Complication Free Rate
Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.
Time frame: 3-months

Secondary outcomes

Complication Free Rate
Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.
Time frame: 3 months through 15 months post implant

Other outcomes

Pacing Threshold at 0.5 ms Pulse Width
Pacing Threshold at 0.5 ms pulse width at 3 Months Post-Implant. During the RELIANCE 4-FRONT PASSIVE fixation PMCF Study pacing threshold measurements are collected from RELIANCE 4-FRONT PASSIVE fixation leads in the standard manual fashion. At least 3 cardiac cycles at a given voltage level shall be obtained before stepping down to the next voltage level. A count of two non-capture beats is required at a given voltage level to declare a loss of capture (LOC) for any of these tests. The threshold is defined as one voltage level above the level where two non-captured beats are observed. Threshold tests must be taken with a pulse width of 0.5 ms.
Time frame: 3 Months Post-Implant
Complication Free Rate
Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant
Time frame: 3 months through 24 months post implant
Sensed Amplitude
Lead performance evaluations of the Reliance 4-FRONT PASSIVE fixation lead have been conducted in accordance with the Physician's Lead Manual. Measurements should fall within the recommended values as mentioned below: Signal Type Amplitude Pacing Threshold Impedance Pacing/Sensing ≥ 5mV ≤1.5 V 300-1200 Ω Defibrillation ≥ 1mV N/A 20-125 Ω The required data from the implant procedure for the study lead is measured with a pacing system analyzer (PSA) to verify adequate signals. Electrical performance of the lead was verified before attaching the lead to the Pulse Generator (PG). After the PG has been implanted evaluation of the study lead using the PG has been performed. Lead measurements were required unless the testing is prohibited by a subject's condition (subject has no intrinsic rhythm). In case the measurements are variable (e.g. in patients with atrial fibrillation), the most reproducible value has been collected.
Time frame: 3 Months Post-Implant
Pacing Impedance
Lead performance evaluations of the Reliance 4-FRONT PASSIVE fixation lead have been conducted in accordance with the Physician's Lead Manual. Measurements should fall within the recommended values as mentioned below: Signal Type Amplitude Pacing Threshold Impedance Pacing/Sensing ≥ 5mV ≤1.5 V 300-1200 Ω Defibrillation ≥ 1mV N/A 20-125 Ω The required data from the implant procedure for the study lead is measured with a pacing system analyzer (PSA) to verify adequate signals. Electrical performance of the lead was verified before attaching the lead to the Pulse Generator (PG). After the PG has been implanted evaluation of the study lead using the PG has been performed. Lead measurements were required unless the testing is prohibited by a subject's condition (subject has no intrinsic rhythm). In case the measurements are variable (e.g. in patients with atrial fibrillation), the most reproducible value has been collected.
Time frame: 3 Months Post-Implant

Results

Posted Nov 20, 2017

Limitations and caveats

Sample size is rather small and the power of the study is only 80%

Participant flow

Participant flow — Overall Study
Milestone	RELIANCE 4-FRONT™ Passive Fixation
Started	167
Completed	152
Not completed	15

Outcome measures

PrimaryComplication Free Rate

Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.

Time frame:: 3-months
Reported as:: Number · percentage of patients without event

Complication Free Rate
percentage of patients without event	RELIANCE 4-FRONT™ Passive Fixation
Complication Free Rate	97.5 (94.4 to 100)

SecondaryComplication Free Rate

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

Time frame:: 3 months through 15 months post implant
Reported as:: Number · percentage of patients without events

Complication Free Rate
percentage of patients without events	RELIANCE 4-FRONT™ Passive Fixation
Complication Free Rate	99.4 (95 to 100)

Other pre-specifiedPacing Threshold at 0.5 ms Pulse Width

Pacing Threshold at 0.5 ms pulse width at 3 Months Post-Implant. During the RELIANCE 4-FRONT PASSIVE fixation PMCF Study pacing threshold measurements are collected from RELIANCE 4-FRONT PASSIVE fixation leads in the standard manual fashion. At least 3 cardiac cycles at a given voltage level shall be obtained before stepping down to the next voltage level. A count of two non-capture beats is required at a given voltage level to declare a loss of capture (LOC) for any of these tests. The threshold is defined as one voltage level above the level where two non-captured beats are observed. Threshold tests must be taken with a pulse width of 0.5 ms.

Time frame:: 3 Months Post-Implant
Reported as:: Mean · Volt

Pacing Threshold at 0.5 ms Pulse Width
Volt	RELIANCE 4-FRONT™ Passive Fixation
Pacing Threshold at 0.5 ms Pulse Width	0.48 ± 0.59

Other pre-specifiedComplication Free Rate

Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant

Time frame:: 3 months through 24 months post implant
Reported as:: Number · percentage of patients without events

Complication Free Rate
percentage of patients without events	RELIANCE 4-FRONT™ Passive Fixation
Complication Free Rate	99.4 (95 to 100)

Other pre-specifiedSensed Amplitude

Lead performance evaluations of the Reliance 4-FRONT PASSIVE fixation lead have been conducted in accordance with the Physician's Lead Manual. Measurements should fall within the recommended values as mentioned below: Signal Type Amplitude Pacing Threshold Impedance Pacing/Sensing ≥ 5mV ≤1.5 V 300-1200 Ω Defibrillation ≥ 1mV N/A 20-125 Ω The required data from the implant procedure for the study lead is measured with a pacing system analyzer (PSA) to verify adequate signals. Electrical performance of the lead was verified before attaching the lead to the Pulse Generator (PG). After the PG has been implanted evaluation of the study lead using the PG has been performed. Lead measurements were required unless the testing is prohibited by a subject's condition (subject has no intrinsic rhythm). In case the measurements are variable (e.g. in patients with atrial fibrillation), the most reproducible value has been collected.

Time frame:: 3 Months Post-Implant
Reported as:: Mean · mVolt

Sensed Amplitude
mVolt	RELIANCE 4-FRONT™ Passive Fixation
Sensed Amplitude	18.5 ± 5.7

Other pre-specifiedPacing Impedance

Time frame:: 3 Months Post-Implant
Reported as:: Mean · Ohm

Pacing Impedance
Ohm	RELIANCE 4-FRONT™ Passive Fixation
Pacing Impedance	474 ± 106

Adverse events

Collected over 3-month follow-up data. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
RELIANCE 4-FRONT™ Passive Fixation	4/167 (2.4%)	84/167 (50.3%)	55/167 (32.9%)

Most frequent serious events

Showing 10 of 58

Most frequent serious events
Event	RELIANCE 4-FRONT™ Passive Fixation
GastrointestinalGastrointestinal disorders	10/167
PulmonaryRespiratory, thoracic and mediastinal disorders	9/167
Dyspnea - Heart failureCardiac disorders	8/167
GenitourinaryRenal and urinary disorders	7/167
RenalRenal and urinary disorders	7/167
Heart failure symptoms - UnspecifiedCardiac disorders	6/167
Myocardial infarctionCardiac disorders	6/167
Chest pain - OtherCardiac disorders	6/167
Cerebrovascular accident (CVA)Vascular disorders	6/167
Multi-system failure - Heart failureCardiac disorders	5/167

Most frequent other events

Showing 10 of 37

Most frequent other events
Event	RELIANCE 4-FRONT™ Passive Fixation
Head, eyes, ears, nose, throat (HEENT)General disorders	10/167
Dyspnea - Heart failureCardiac disorders	7/167
Chest pain - OtherCardiac disorders	7/167
Physical traumaGeneral disorders	6/167
MusculoskeletalMusculoskeletal and connective tissue disorders	6/167
GastrointestinalGastrointestinal disorders	5/167
Inappropriate tachy therapy - SVTCardiac disorders	4/167
Atrial fibrillation (AF)Cardiac disorders	4/167
GenitourinaryRenal and urinary disorders	4/167
Not yet classifiedGeneral disorders	3/167

Baseline characteristics

Age, Continuous
Age, Continuous(years)	RELIANCE 4-FRONT™ Passive Fixation
Mean	66.90 ± 10.47

Sex: Female, Male
Sex: Female, Male(Participants)	RELIANCE 4-FRONT™ Passive Fixation
Female	33
Male	134

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	RELIANCE 4-FRONT™ Passive Fixation
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	166
More than one race	0
Unknown or Not Reported	1

Study locations

11 sites

German Heart Center
Berlin, 13353, Germany
Meir Medical Center
Kfar-Saba, 44281, Israel
Beilinson Medical Center
Petah-Tikva, 49100, Israel
Sheba Medical Center
Tel Hashomer, 52621, Israel
Fondazione di Ricerca e Cura 'Giovanni Paolo II
Campobasso, Italy
Ospedale Alessandro Manzoni
Lecco, 23900, Italy
Clinica Mediterranea
Naples, 80121, Italy
Ospedale Buon Consiglio
Naples, 80123, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56127, Italy
Osp. Civile S. Maria Delle Grazie
Pozzuoli, 80078, Italy
Ospedale San Pietro Fatebenefratelli
Rome, 00189, Italy

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01856491
Lead sponsor: Boston Scientific Corporation
Responsible party: Sponsor
First posted: May 17, 2013
Start date: Dec 16, 2013
Primary completion: Nov 2, 2015
Completion: Nov 13, 2017
Results posted: Nov 20, 2017
Last update: Apr 30, 2019

Study contacts

Maria Grazia Bongiorni, MD

principal investigator · University Hospital Pisa, Italy

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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