Safety and Performance Study of the Reliance 4-Front Lead
- Conditions
- Tachycardia
- Interventions
- Device: Reliance 4-Front lead implantation
- Registration Number
- NCT01772576
- Lead Sponsor
- Boston Scientific Corporation
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 167
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Reliance 4-Front Reliance 4-Front lead implantation Single arm, all patients will be implanted with the Reliance 4-Front lead
- Primary Outcome Measures
Name Time Method Complication Free Rate 3-months follow-up Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.
- Secondary Outcome Measures
Name Time Method Complication Free Rate 3 months through 15 months post implant Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.
Trial Locations
- Locations (15)
Sheba Medical Center
🇮🇱Tel Hashomer, Israel
Landesklinikum St. Poelten
🇦🇹St. Pölten, Austria
Aarhus University Hospitals
🇩🇰Aarhus, Denmark
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Queen Mary Hospital
🇨🇳Hong Kong, China
Institut Cardiovasculaire - Paris Sud
🇫🇷Massy, France
Barzilai Medical Center
🇮🇱Ashkelon, Israel
Ospedale Alessandro Manzoni
🇮🇹Lecco, Italy
Karolinska Hospital
🇸🇪Stockholm, Sweden
Golden Jubilee National Hospital
🇬🇧Clydebank, United Kingdom
Hospital de Santa Cruz
🇵🇹Carnaxide, Portugal
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Italy
Hospital Universitario Virgen de la Victoria
🇪🇸Malaga, Spain
Bristol Royal Infirmary
🇬🇧Bristol, United Kingdom
Deutsches Herzzentrum Berlin
🇩🇪Berlin, Germany