Safety and Performance Study of the Reliance 4-Front Lead

NCT01772576 | Completed Results FDA Device

• 2 other identifiers: BSC-CDM00052753C1830
• Study Type: interventional
• Target: 167
• Locations: 11 countries
• Sites: 15

Brief Summary

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.

Conditions

Tachycardia

Keywords

Reliance; Implantable Cardioverter Defibrillator (ICD); Cardiac Resynchronization Therapy - Defibrillator (CRT-D)

Outcome Measures

Primary Outcomes (1)

• Complication Free Rate

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

  3-months follow-up

Secondary Outcomes (1)

• Complication Free Rate

  3 months through 15 months post implant

Other Outcomes (4)

• Complication Free Rate

  3 Months through 24 Months Post-Implant

• Pacing Threshold

  3-months post-implant

• Sensed Amplitude

  3 Months Post-Implant

Study Arms (1)

Reliance 4-Front

EXPERIMENTAL

Single arm, all patients will be implanted with the Reliance 4-Front lead

Device: Reliance 4-Front lead implantation

Interventions

Reliance 4-Front lead implantation DEVICE

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.

Reliance 4-Front

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (15)

Landesklinikum St. Poelten

Sankt Pölten, 3100, Austria

Location

Queen Mary Hospital

Hong Kong, China

Location

Aarhus University Hospitals

Aarhus, 8200, Denmark

Location

Institut Cardiovasculaire - Paris Sud

Massy, 91300, France

Location

Deutsches Herzzentrum Berlin

Berlin, 13353, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Barzilai Medical Center

Ashkelon, 78306, Israel

Location

Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Ospedale Alessandro Manzoni

Lecco, 23900, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, 56127, Italy

Location

Hospital de Santa Cruz

Carnaxide, 2790-134, Portugal

Location

Hospital Universitario Virgen de la Victoria

Málaga, 29019, Spain

Location

Karolinska Hospital

Stockholm, 17176, Sweden

Location

Bristol Royal Infirmary

Bristol, BS2 8HW, United Kingdom

Location

Golden Jubilee National Hospital

Clydebank, G81 4HX, United Kingdom

Location

MeSH Terms

Conditions

Tachycardia

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

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

Results Point of Contact

• Title: Ursula Appl
• Organization: Boston Scientific

ursula.appl@bsci.com

003224167213

Study Officials

• Maria Grazia Bongiorni, MD

  University Hospital Pisa, Italy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2013
• First Posted: January 21, 2013
• Study Start: October 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: August 1, 2016
• Last Updated: July 2, 2017
• Results First Posted: June 2, 2017

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2); GB (2); FR (1); DK (1); PT (1); DE (2); IL (2); ES (1); CN (1); SE (1); AU (1)