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

April 19, 2019 updated by: Boston Scientific Corporation

RELIANCE 4-FRONT™ Passive Fixation Defibrillation Lead Post Market Clinical Follow-Up (PMCF) Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
167

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Implantation of transvenous defibrillation lead with passive fixation mechanism.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complication Free Rate
Time Frame: 3-months
Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.
3-months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complication Free Rate
Time Frame: 3 months through 15 months post implant
Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.
3 months through 15 months post implant

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pacing Threshold at 0.5 ms Pulse Width
Time Frame: 3 Months Post-Implant
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.
3 Months Post-Implant
Complication Free Rate
Time Frame: 3 months through 24 months post implant
Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant
3 months through 24 months post implant
Sensed Amplitude
Time Frame: 3 Months Post-Implant

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.
3 Months Post-Implant
Pacing Impedance
Time Frame: 3 Months Post-Implant

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.
3 Months Post-Implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 16, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 2, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 13, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C1868

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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