Post Market Surveillance Study Following Clinical Routine
Conditions
Brief summary
The objective of this Post Market Clinical Follow-up (PMCF) is to collect data on the performance of the Ingenio 2 CRT-P devices and to document that device-related events, device malfunctions or device deficiencies (DDs) do not increase safety risks in Ingenio 2 CRT-P devices (CRT-Ps), both in general and specific to the new features and hardware of the devices.
Detailed description
Prospective, non-randomized, multi-center, single group, post market clinical study The devices are fully commercially available and all subjects are planned to receive a CRT-P implant as part of their standard of care (SOC). The assignment of the specific Ingenio 2 device is physician's choice and will consider leads currently in place from previous devices and planned new leads (e.g., Acuity X4 and/or other LV leads). Enrollment and Consenting Clinic Visit (≤ 30 days prior to implant procedure) (required) * Implant Procedure (Day 0; all future follow ups based on this date) (required) * Pre-Discharge Clinic Visit (after pocket closure and wound coverage 0-5 days post-implant procedure) (required) * 1 month post-implant Clinic Visit (30 ± 15 days) (required) * 3 month post-implant Clinic Visit (91 ± 21 days) (required) * Latitude-based Close-out (91 - 120 days months post last enrollment) (reporting only required) * Unscheduled clinic follow-up (any clinic visit between pre-discharge and 3 month follow up which is in addition to the 1 month follow up; per center SOC or subject needs; event reporting only) * Re-implant/Revision (as needed) * During the trial unanticipated serious adverse device effects (USADEs), serious adverse device effects (SADEs), adverse device effects (ADEs), DDs, all serious adverse events (SAEs), deaths, and changes in the device system must be reported (enrollment to Closeout). Study Duration Enrollment is expected to take 12 months. The study will be considered complete (primary endpoint completion) after all subjects have completed the Latitude based close-out 3-4 months after the last study enrollment. All study required visits will be completed as part of regularly scheduled clinic visits.
Interventions
DEVICECRT-P indicated patients
Patients who are indicated for a CRT-P device are planned to be implanted with a CRT-P device
Sponsors
ICON plc
Boston Scientific Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years or above, or above legal age to give informed consent specific to state and national law 2. Willing and capable of providing informed consent 3. Planned to be implanted or replaced with a VISIONIST Ingenio 2 CRT-P device 4. Planned to be implanted with a 3-lead CRT-P system 5. Planned to be connected to the remote data collection through the Latitude® system 6. Able to do a 6 minute walk test 7. Maximum sensor rate of age predicted maximal heart rate (APMHR) 80% should be clinically acceptable 8. Willing and capable of participating in all visits associated with this study at an approved clinical study center and at the intervals defined-
Exclusion criteria
1. Documented life expectancy of less than 12 months 2. Currently on the active heart transplant list 3. Enrolled in any other concurrent study without prior written approval from Boston Scientific, 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 CRT-P Study (i.e., should not cause additional or missed visits) * Rally CRT-P Study outcomes (i.e., involve medications that could affect the heart rate of the subject) * Conduct of the Rally CRT-P Study per Good Clinical Practice (GCP)/ International Standard Organization (ISO) 14155:2011/ local regulations as applicable 4. In chronic atrial fibrillation 5. APMHR needs to be programmed \< 80%. 6. Not planned to receive a functional atrial lead 7. Per the implanting physician's discretion, subject is not a suitable candidate to receive the study device as determined during the implant procedure 8. Women of childbearing potential who are or might be pregnant at the time of study enrollment 9. Unwilling or unable to participate in all scheduled study follow up visits at an approved study center 10. Does not anticipate being a resident of the area for the scheduled duration of the trial. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Without CRT-P Device Related Complications | 3 months post-implant | Evaluate the Device-Related Complication Free Rate (DRCFR) at 3 months post-implant, which was based on complications that were related to the CRT-P device. A device-related complication was an adverse event that resulted in death, serious injury, a correction using invasive intervention or permanent loss of device functions, and that was assessed as related to the device. |
| LV Pacing Threshold | 3 months post-implant | Primary Effectiveness endpoint: evaluation of the left ventricular pacing threshold measurements performed at 0.5 ms pulse width at 3 months post-implant. |
Countries
Finland, Germany
Participant flow
Recruitment details
The first subject was enrolled on 11 May 2015 and the study was completed on 22 March 2017, which corresponds to the last visit of the last subject. A total of 64 subjects across 8 centers were enrolled in Finland and Germany.
Participants by arm
| Arm | Count |
|---|---|
| Actively Enrolled Patients Patients actively enrolled and implanted with a 3-lead CRT-P system. | 61 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Consent ineligible | 1 |
| Overall Study | Death | 3 |
| Overall Study | Did not undergo implant procedure | 1 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Actively Enrolled Patients | — |
|---|---|---|
| Age, Continuous | 73.3 years STANDARD_DEVIATION 10.06 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Finland | 15 participants | — |
| Region of Enrollment Germany | 46 participants | — |
| Sex: Female, Male Female | 24 Participants | — |
| Sex: Female, Male Male | 37 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 61 |
| other Total, other adverse events | 40 / 61 |
| serious Total, serious adverse events | 20 / 61 |
Outcome results
Primary
LV Pacing Threshold
Primary Effectiveness endpoint: evaluation of the left ventricular pacing threshold measurements performed at 0.5 ms pulse width at 3 months post-implant.
Time frame: 3 months post-implant
Population: 61 actively enrolled subjects were included in the analysis. 3 subjects did not receive the study device.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Actively Enrolled Patients | LV Pacing Threshold | 1.65 Volt |
p-value: <0.001t-test, 1 sided
Primary
Percentage of Participants Without CRT-P Device Related Complications
Evaluate the Device-Related Complication Free Rate (DRCFR) at 3 months post-implant, which was based on complications that were related to the CRT-P device. A device-related complication was an adverse event that resulted in death, serious injury, a correction using invasive intervention or permanent loss of device functions, and that was assessed as related to the device.
Time frame: 3 months post-implant
Population: Out of 61 actively enrolled subjects (3 subjects were not implanted with the study device), 55 patients continued the study for at least 3 months: 6 subjects were excluded from analysis because either they died or withdrew before 3 months analysis, or because no 3 months data was available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Actively Enrolled Patients | Percentage of Participants Without CRT-P Device Related Complications | 100 % of participants |
p-value: <0.001exact binomial rate