Safety and Performance Study of the Reliance 4-Front Lead

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01772576
First received: January 17, 2013
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Tachycardia
Device: Reliance 4-Front lead implantation

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: RELIANCE 4-FRONT™ Active Fixation Defibrillation Lead Post Market Clinical Follow-Up (PMCF) Study

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • complication free rate [ Time Frame: 3-months follow-up ] [ Designated as safety issue: No ]
    Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.


Secondary Outcome Measures:
  • Complication Free Rate [ Time Frame: 3 months through 15 months post implant ] [ Designated as safety issue: No ]
    Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.


Other Outcome Measures:
  • Complication Free Rate [ Time Frame: 3 Months through 24 Months Post-Implant ] [ Designated as safety issue: No ]
    Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant

  • Pacing Threshold [ Time Frame: 3-months post-implant ] [ Designated as safety issue: No ]
    Pacing Threshold at 0.5 ms pulse width at 3 Months Post-Implant

  • Sensed Amplitude [ Time Frame: 3 Months Post-Implant ] [ Designated as safety issue: No ]
    Sensed Amplitude at 3 Months Post-Implant

  • Pacing impedance [ Time Frame: 3 Months Post-Implant ] [ Designated as safety issue: No ]
    Pacing Impedance at 3 Months Post-Implant


Estimated Enrollment: 167
Study Start Date: October 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Reliance 4-Front
Single arm, all patients will be implanted with the Reliance 4-Front lead
Device: Reliance 4-Front lead implantation
The patients selected for participation should be from the investigator's general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system.

Detailed Description:

The RELIANCE 4-FRONT 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 active fixation defibrillation leads.

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

Up to 20 Investigational centers located in Europe and Asia Pacific. Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.

Lead-related complications associated with the RELIANCE 4-FRONT active 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 active 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 active 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 PMCF Study will use standard statistical methodology as specified more in detail in the protocol.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 Active 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772576

Locations
Austria
Landesklinikum St. Poelten
St. Pölten, Austria, 3100
China
Queen Mary Hospital
Hong Kong, China
Denmark
Aarhus University Hospitals
Aarhus, Denmark, 8200
France
Institut Cardiovasculaire - Paris Sud
Massy, France, 91300
Germany
Deutsches Herzzentrum Berlin
Berlin, Germany, 13353
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Israel
Barzilai Medical Center
Ashkelon, Israel, 78306
Sheba Medical Center
Tel Hashomer, Israel, 52621
Italy
Ospedale Alessandro Manzoni
Lecco, Italy, 23900
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56127
Portugal
Hospital de Santa Cruz
Carnaxide, Portugal, 2790-134
Spain
Hospital Universitario Virgen de la Victoria
Malaga, Spain, 29019
Sweden
Karolinska Hospital
Stockholm, Sweden, 17176
United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom, BS2 8HW
Golden Jubilee National Hospital
Clydebank, United Kingdom, G81 4HX
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Maria Grazia Bongiorni, MD University Hospital Pisa, Italy
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01772576     History of Changes
Other Study ID Numbers: BSC-CDM00052753, C1830
Study First Received: January 17, 2013
Last Updated: March 11, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Denmark: Danish Medicines Agency
Portugal: Ethics Committee for Clinical Research
Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Boston Scientific Corporation:
Reliance
Implantable Cardioverter Defibrillator (ICD)
Cardiac Resynchronization Therapy - Defibrillator (CRT-D)

Additional relevant MeSH terms:
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014