Tachycardia, Ventricular Fibrillation, Ventricular Flutter
Conditions
Keywords
RELIANCE 4-FRONT, Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy - Defibrillator (CRT-D)
Brief summary
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.
Detailed description
The RELIANCE 4-FRONT Passive Fixation 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 passive fixation defibrillation leads. A total of 167 patients (including 10 % attrition) are required to evaluate the Primary Endpoint. Up to 10 Investigational centers located in Europe and Israel. Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant. Lead-related complications associated with the RELIANCE 4-FRONT passive 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 passive 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 passive 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 passive fixation PMCF Study will use standard statistical methodology as specified more in detail in the protocol.
Interventions
DEVICERELIANCE 4-FRONT™ Passive Fixation lead implantation
Implantation of transvenous defibrillation lead with passive fixation mechanism.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complication Free Rate | 3-months | Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication Free Rate | 3 months through 15 months post implant | Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pacing Threshold at 0.5 ms Pulse Width | 3 Months Post-Implant | 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. |
| Complication Free Rate | 3 months through 24 months post implant | Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant |
| Sensed Amplitude | 3 Months Post-Implant | 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 Ω Defibrillation ≥ 1mV N/A 20-125 Ω 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. |
| Pacing Impedance | 3 Months Post-Implant | 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 Ω Defibrillation ≥ 1mV N/A 20-125 Ω 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. |
Countries
Germany, Israel, Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RELIANCE 4-FRONT™ Passive Fixation Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead
RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism. | 167 |
| Total | 167 |
Baseline characteristics
| Characteristic | RELIANCE 4-FRONT™ Passive Fixation |
|---|---|
| Age, Continuous | 66.90 years STANDARD_DEVIATION 10.47 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 166 Participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 134 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 167 |
| other Total, other adverse events | 55 / 167 |
| serious Total, serious adverse events | 84 / 167 |
Outcome results
Primary
Complication Free Rate
Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.
Time frame: 3-months
Population: 167 have been enrolled. 165 were included in the analysis because for 2 patients the leads have not been implanted
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RELIANCE 4-FRONT™ Passive Fixation | Complication Free Rate | 97.5 percentage of patients without event |
Secondary
Complication Free Rate
Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.
Time frame: 3 months through 15 months post implant
Population: Subjects were eligible for the secondary endpoint analysis if their date of last follow-up was ≥92 days post-implant procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RELIANCE 4-FRONT™ Passive Fixation | Complication Free Rate | 99.4 percentage of patients without events |
Other Pre-specified
Complication Free Rate
Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant
Time frame: 3 months through 24 months post implant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RELIANCE 4-FRONT™ Passive Fixation | Complication Free Rate | 99.4 percentage of patients without events |
Other Pre-specified
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 Ω Defibrillation ≥ 1mV N/A 20-125 Ω 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.
Time frame: 3 Months Post-Implant
Population: 167 patients have been enrolled. For 150 patients we were able to collect the 3 month pacing impedance
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RELIANCE 4-FRONT™ Passive Fixation | Pacing Impedance | 474 Ohm | Standard Deviation 106 |
Other Pre-specified
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.
Time frame: 3 Months Post-Implant
Population: 167 have been enrolled. 138 were included in the analysis because we have the lead measurements for those number of patients collected .
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RELIANCE 4-FRONT™ Passive Fixation | Pacing Threshold at 0.5 ms Pulse Width | 0.48 Volt | Standard Deviation 0.59 |
Other Pre-specified
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 Ω Defibrillation ≥ 1mV N/A 20-125 Ω 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.
Time frame: 3 Months Post-Implant
Population: 167 patients were enrolled. From 141 patients we could collected the sensed amplitude at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RELIANCE 4-FRONT™ Passive Fixation | Sensed Amplitude | 18.5 mVolt | Standard Deviation 5.7 |