Safety and Performance Study of the Reliance 4-Front Lead

Tachycardia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01772576
• Other study ID #: BSC-CDM00052753
• Secondary ID: C1830
• Status: Completed
• Phase: N/A
• First received: January 17, 2013
• Last updated: February 14, 2017
• Start date: October 2012
• Est. completion date: August 2016

Study information

• Verified date: April 2016
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: August 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tachycardia

Intervention

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.

Locations

Country	Name	City	State
Austria	Landesklinikum St. Poelten	St. Pölten
China	Queen Mary Hospital	Hong Kong
Denmark	Aarhus University Hospitals	Aarhus
France	Institut Cardiovasculaire - Paris Sud	Massy
Germany	Deutsches Herzzentrum Berlin	Berlin
Germany	Medizinische Hochschule Hannover	Hannover
Israel	Barzilai Medical Center	Ashkelon
Israel	Sheba Medical Center	Tel Hashomer
Italy	Ospedale Alessandro Manzoni	Lecco
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
Portugal	Hospital de Santa Cruz	Carnaxide
Spain	Hospital Universitario Virgen de la Victoria	Malaga
Sweden	Karolinska Hospital	Stockholm
United Kingdom	Bristol Royal Infirmary	Bristol
United Kingdom	Golden Jubilee National Hospital	Clydebank

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Austria,  China,  Denmark,  France,  Germany,  Israel,  Italy,  Portugal,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complication Free Rate	Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant	3 Months through 24 Months Post-Implant
Other	Pacing Threshold	Pacing Threshold at 0.5 ms pulse width at 3 Months Post-Implant	3-months post-implant
Other	Sensed Amplitude	Sensed Amplitude at 3 Months Post-Implant	3 Months Post-Implant
Other	Pacing impedance	Pacing Impedance at 3 Months Post-Implant	3 Months Post-Implant
Primary	complication free rate	Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.	3-months follow-up
Secondary	Complication Free Rate	Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.	3 months through 15 months post implant