Heartfailure
Conditions
Keywords
Phrenic Nerve Stimulation, Heartfailure treatment, CRT-D therapy, Quadripolar lead, Lead related complication free rate
Brief summary
The objective of this study is to collect clinical data on safety and performance of ACUITY X4® leads when used in a standard clinical setting. It is a prospective, non-randomized, observational multicenter study evaluating standard of care. For Post Market Clinical Follow up (PMCF) purposes the 3 month implant success rate, adverse events and basic parameters of the lead will be assessed. The cohort of subjects included in this evaluation will be the first 200 subjects which are indicated for PMCF in Rally X4 to receive an ACUITY X4® lead implant. Study endpoints: Phrenic Nerve Stimulation (PNS) related CFR through 6 months post-implant (Defined as: rate of freedom from loss of function or operative system revision due to unacceptable PNS threshold) Lead-related Complication-Free Rate (CFR) from Implant through 3 months post-implant.
Detailed description
Clinic visits will occur at: * Enrollment and Consenting Clinic Visit (≤ 30 days prior to implant procedure) * Implant Procedure (Day 0; all future follow ups based on this date) * Pre-Discharge Clinic Visit (≤ 7 days post implant procedure) (Required) * One to 6 Month Clinic Visit (20 to 180 days post implant procedure) (Required) * Interim Visit(s) (Any time between the 1 to 6 Month Clinic Visit and Close-out Clinic Visit) (Following study center specific standard of care) (Device follow up optional) AE - reporting required * Close-out Clinic Visit (30 months ± 90 days, OR 180 days ± 90 days after the study is closed to enrollment, whichever comes first) (Required) * During the trial all AEs, deaths, and changes in the device system must be reported * Devices of subjects who have received a Latitude device will be followed by the Boston Scientific (BSC) Latitude team. Device Data as defined in the Clinical Investigation Plan (CIP), device alerts, and diagnostic data from the standard Latitude database may be collected and entered into the study database at any time.
Interventions
DEVICELeft Ventricular lead implant: ACUITY X4® Lead Family
Implantation of (cardiac re-synchronization therapy with defibrillator) CRT-D devices for heartfailure treatment
Sponsors
ICON plc
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Subject is willing and capable of providing informed consent 2. Subject is planned to be implanted with an ACUITY X4® lead for left-ventricular pacing and sensing via the coronary venous system in conjunction with a compatible BSC pulse generator 3. Subject is willing and capable of participating in all visits associated with this study at an approved clinical study center and at the intervals defined by this CIP 4. Subject is age 18 or above, or of legal age to give informed consent specific to state and national law
Exclusion criteria
1. Subjects with a hypersensitivity to a maximum single dose of 0.51 mg dexamethasone acetate 2. Subject is enrolled in any other concurrent study without prior written approval from 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 RALLY X4 Study (i.e. should not cause additional or missed visits); * RALLY X4 Study outcome (i.e. involve medications that could affect the heart rate of the subject); * Conduct of the RALLY X4 Study per GCP/ ISO 14155:2011/ local regulations as applicable 3. Per the implanting physician's discretion, the subject is not a suitable candidate to receive the study device as determined during the implant procedure 4. Women of childbearing potential who are or might be pregnant at the time of study enrollment or ACUITY X4® lead implant. 5. Subject is unwilling or unable to participate in all scheduled study follow up visits at an approved study center 6. Subject does not anticipate being a resident of the area for the scheduled duration of the trial 7. Subject's physician does not allow participation \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phrenic Nerve Complication Free Rate | 6 months post-implant | The Phrenic Nerve Stimulation (PNS) related Complication Free rate (CFR) through 6 months post-implant is defined as the rate of freedom from loss of function or operative system revision due to unacceptable PNS threshold |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3 Month Lead-related Complication-Free Rate (CFR) | 3 months post-implant | Lead-related Complication-Free Rate (CFR) from implant through 3 months post-implant. Lead-related complications associated with the ACUITY X4® lead were counted towards this endpoint. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 3 Month Implant Success Rate for Indicated Subjects | 3 months post-implant | Post Market Clinical Follow-up (PMCF) of the ACUITY X4® lead was evaluated in this study. The outcome of interest is the 3 month implant success rate. The cohort of subjects included in this evaluation is the first 200 subjects to receive an ACUITY X4® lead implant and meet the PMCF eligibility criteria outlined below. The outcomes of interest for the PMCF supplemental analysis is the percent of subjects successfully implanted with an ACUITY X4® lead. Implant success is defined as the ability of the ACUITY X4® lead to be implanted and deliver CRT therapy. Subjects who have multiple lead implant attempts during the procedure, but are eventually successfully implanted with the ACUITY X4® lead and receive CRT therapy are classified as a successful implant. |
Countries
Austria, Belgium, Colombia, Denmark, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Portugal, Singapore, Spain, Switzerland, United Kingdom
Participant flow
Recruitment details
The first subject was enrolled on 10 February 2014. The clinical phase of the study was completed on 30 September 2016 which was the date of the last subject's close-out visit. A total of 863 subjects across 82 centers were enrolled in the study in Europe, Asia and South America.
Participants by arm
| Arm | Count |
|---|---|
| Heart Failure Patients * Subjects with heart failure who receive stable optimal pharmacologic therapy
* Moderate to severe heart failure (NYHA Class III-IV) with ejection fraction (EF) ≤ 35% and QRS duration ≥ 120 ms
* Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or non-ischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure.
The study is collecting observational data on regular CRT-D device implants with special focus on the left ventricular ACUITY X4® Lead Family' .
Left Ventricular lead implant: ACUITY X4® Lead Family: Implantation of (cardiac re-synchronization therapy with defibrillator) CRT-D devices for heartfailure treatment | 863 |
| Total | 863 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 20 |
| Overall Study | Attempted to implant withoput success | 43 |
| Overall Study | Consent ineligible | 1 |
| Overall Study | Death | 54 |
| Overall Study | Did not undergo implant procedure | 24 |
| Overall Study | Lost to Follow-up | 51 |
| Overall Study | Not defined | 4 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 16 |
Baseline characteristics
| Characteristic | Heart Failure Patients | — |
|---|---|---|
| Age, Continuous | 67.5 years STANDARD_DEVIATION 10.09 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Austria | 15 participants | — |
| Region of Enrollment Belgium | 5 participants | — |
| Region of Enrollment Colombia | 13 participants | — |
| Region of Enrollment Denmark | 30 participants | — |
| Region of Enrollment Finland | 23 participants | — |
| Region of Enrollment France | 119 participants | — |
| Region of Enrollment Germany | 162 participants | — |
| Region of Enrollment Hong Kong | 9 participants | — |
| Region of Enrollment Ireland | 12 participants | — |
| Region of Enrollment Israel | 47 participants | — |
| Region of Enrollment Italy | 124 participants | — |
| Region of Enrollment Japan | 60 participants | — |
| Region of Enrollment Netherlands | 57 participants | — |
| Region of Enrollment Portugal | 33 participants | — |
| Region of Enrollment Singapore | 18 participants | — |
| Region of Enrollment Spain | 67 participants | — |
| Region of Enrollment Switzerland | 31 participants | — |
| Region of Enrollment United Kingdom | 38 participants | — |
| Sex: Female, Male Female | 189 Participants | — |
| Sex: Female, Male Male | 674 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 54 / 838 |
| other Total, other adverse events | 452 / 838 |
| serious Total, serious adverse events | 338 / 838 |
Outcome results
Primary
Phrenic Nerve Complication Free Rate
The Phrenic Nerve Stimulation (PNS) related Complication Free rate (CFR) through 6 months post-implant is defined as the rate of freedom from loss of function or operative system revision due to unacceptable PNS threshold
Time frame: 6 months post-implant
Population: 795 patients successfully implanted with ACUITY X4 lead
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Heart Failure Patients | Phrenic Nerve Complication Free Rate | 99.5 % of participants |
p-value: <0.0001exact binominal methodology
Secondary
3 Month Lead-related Complication-Free Rate (CFR)
Lead-related Complication-Free Rate (CFR) from implant through 3 months post-implant. Lead-related complications associated with the ACUITY X4® lead were counted towards this endpoint.
Time frame: 3 months post-implant
Population: 795 patients successfully implanted with ACUITY X4 lead
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Heart Failure Patients | 3 Month Lead-related Complication-Free Rate (CFR) | 98.8 % of participants |
Other Pre-specified
3 Month Implant Success Rate for Indicated Subjects
Post Market Clinical Follow-up (PMCF) of the ACUITY X4® lead was evaluated in this study. The outcome of interest is the 3 month implant success rate. The cohort of subjects included in this evaluation is the first 200 subjects to receive an ACUITY X4® lead implant and meet the PMCF eligibility criteria outlined below. The outcomes of interest for the PMCF supplemental analysis is the percent of subjects successfully implanted with an ACUITY X4® lead. Implant success is defined as the ability of the ACUITY X4® lead to be implanted and deliver CRT therapy. Subjects who have multiple lead implant attempts during the procedure, but are eventually successfully implanted with the ACUITY X4® lead and receive CRT therapy are classified as a successful implant.
Time frame: 3 months post-implant
Population: At data cutoff date on 16 November 2015, 201 enrolled subjects met all of the PMCF eligibility criteria and were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Heart Failure Patients | 3 Month Implant Success Rate for Indicated Subjects | 99.5 % of participants |
p-value: <0.0001exact binominal methodology