Optimizing Pacing Therapy by Using Multi-Programmable Pulse Generators for Cardiac Resynchronization Pacing (CRT-P)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 8
- 主要终点
- Percentage of Participants Without CRT-P Device Related Complications
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or above, or above legal age to give informed consent specific to state and national law
- •Willing and capable of providing informed consent
- •Planned to be implanted or replaced with a VISIONIST Ingenio 2 CRT-P device
- •Planned to be implanted with a 3-lead CRT-P system
- •Planned to be connected to the remote data collection through the Latitude® system
- •Able to do a 6 minute walk test
- •Maximum sensor rate of age predicted maximal heart rate (APMHR) 80% should be clinically acceptable
- •Willing and capable of participating in all visits associated with this study at an approved clinical study center and at the intervals defined-
排除标准
- •Documented life expectancy of less than 12 months
- •Currently on the active heart transplant list
- •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
- •In chronic atrial fibrillation
- •APMHR needs to be programmed < 80%.
- •Not planned to receive a functional atrial lead
- •Per the implanting physician's discretion, subject is not a suitable candidate to receive the study device as determined during the implant procedure
- •Women of childbearing potential who are or might be pregnant at the time of study enrollment
- •Unwilling or unable to participate in all scheduled study follow up visits at an approved study center
- •Does not anticipate being a resident of the area for the scheduled duration of the trial. -
结局指标
主要结局
Percentage of Participants Without CRT-P Device Related Complications
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点