Ventricular Fibrillation Clinical Trial
Official title:
RELIANCE 4-FRONT™ Passive Fixation Defibrillation Lead Post Market Clinical Follow-Up (PMCF) Study
Verified date | April 2019 |
Source | Boston Scientific Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 167 |
Est. completion date | November 13, 2017 |
Est. primary completion date | November 2, 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 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 |
Country | Name | City | State |
---|---|---|---|
Germany | German Heart Center | Berlin | |
Israel | Meir Medical Center | Kfar-Saba | |
Israel | Beilinson Medical Center | Petah-Tikva | |
Israel | Sheba Medical Center | Tel Hashomer | |
Italy | Fondazione di Ricerca e Cura 'Giovanni Paolo II | Campobasso | |
Italy | Ospedale Alessandro Manzoni | Lecco | |
Italy | Clinica Mediterranea | Naples | |
Italy | Ospedale Buon Consiglio | Naples | |
Italy | Azienda Ospedaliero Universitaria Pisana | Pisa | |
Italy | Osp. Civile S. Maria Delle Grazie | Pozzuoli | |
Italy | Ospedale San Pietro Fatebenefratelli | Rome |
Lead Sponsor | Collaborator |
---|---|
Boston Scientific Corporation |
Germany, Israel, Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pacing Threshold at 0.5 ms Pulse Width | 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 | |
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 | Sensed Amplitude | 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 O Defibrillation = 1mV N/A 20—125 O 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 | |
Other | Pacing Impedance | 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 O Defibrillation = 1mV N/A 20—125 O 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 | |
Primary | Complication Free Rate | Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant. | 3-months | |
Secondary | Complication Free Rate | Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant. | 3 months through 15 months post implant |
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