Tachycardia
Conditions
Keywords
Reliance, 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™ 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.
Interventions
DEVICEReliance 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.
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complication Free Rate | 3-months follow-up | 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 |
|---|---|---|
| Complication Free Rate | 3 Months through 24 Months Post-Implant | Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant |
| Pacing Threshold | 3-months post-implant | Pacing Threshold at 0.5 ms pulse width at 3 Months Post-Implant |
| Sensed Amplitude | 3 Months Post-Implant | Sensed Amplitude at 3 Months Post-Implant |
| Pacing Impedance | 3 Months Post-Implant | Pacing Impedance at 3 Months Post-Implant |
Countries
Austria, China, Denmark, France, Germany, Israel, Italy, Portugal, Spain, Sweden, United Kingdom
Participant flow
Recruitment details
167 patients were enrolled in the study. Patients were considered enrolled when the consent form was signed regardless whether they received the RELIANCE 4FRONT lead or not. Recruitment started on 22 November 2012. Last patient was enrolled 9 March 2014.
Pre-assignment details
No wash out or run-in period was planned for the study. 3 patients did not receive the study lead: lead not available at site, wrong lead chosen and patient needed MRI (magnet resonance imaging) compatible lead, while the RELIANCE 4FRONT lead was not labeled MRI compatible.
Participants by arm
| Arm | Count |
|---|---|
| Reliance 4-Front Single arm, all patients will be implanted with the Reliance 4-Front lead
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. | 167 |
| Total | 167 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Death | 15 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Study device not used | 3 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Reliance 4-Front | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 102 Participants | — |
| Age, Categorical Between 18 and 65 years | 65 Participants | — |
| Age, Continuous | 65.26 years STANDARD_DEVIATION 10.94 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Austria | 10 participants | — |
| Region of Enrollment China | 10 participants | — |
| Region of Enrollment Denmark | 25 participants | — |
| Region of Enrollment France | 4 participants | — |
| Region of Enrollment Germany | 20 participants | — |
| Region of Enrollment Israel | 44 participants | — |
| Region of Enrollment Italy | 15 participants | — |
| Region of Enrollment Portugal | 4 participants | — |
| Region of Enrollment Spain | 4 participants | — |
| Region of Enrollment Sweden | 9 participants | — |
| Region of Enrollment United Kingdom | 22 participants | — |
| Sex: Female, Male Female | 29 Participants | — |
| Sex: Female, Male Male | 138 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 14 / 164 |
| other Total, other adverse events | 69 / 167 |
| serious Total, serious adverse events | 89 / 167 |
Outcome results
Primary
Complication Free Rate
Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.
Time frame: 3-months follow-up
Population: Patients enrolled in the study and having received the RELIANCE 4FRONT active fixation lead
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reliance 4-Front | Complication Free Rate | 96.3 percentage of all subjects |
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: 156 patients remained after 3 months in the study without lead related complication. Those were used for the secondary endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reliance 4-Front | Complication Free Rate | 98.7 percentage of total participants |
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
Population: Patients remaining after the 3 months follow-up in the study until the 24 months follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reliance 4-Front | Complication Free Rate | 98.7 percentage of all participants |
Other Pre-specified
Pacing Impedance
Pacing Impedance at 3 Months Post-Implant
Time frame: 3 Months Post-Implant
Population: Patients with 3 month follow-up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Reliance 4-Front | Pacing Impedance | 474 Ohm |
Other Pre-specified
Pacing Threshold
Pacing Threshold at 0.5 ms pulse width at 3 Months Post-Implant
Time frame: 3-months post-implant
Population: Patients having undergone the 3 months follow-up visit.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Reliance 4-Front | Pacing Threshold | 0.53 Volt |
Other Pre-specified
Sensed Amplitude
Sensed Amplitude at 3 Months Post-Implant
Time frame: 3 Months Post-Implant
Population: Patients having undergone the 3 months follow-up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Reliance 4-Front | Sensed Amplitude | 18.1 mV |