Ingenio Device Algorithm Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 41
- 主要终点
- Accuracy of Commanded Right Atrial Automatic Threshold (RAAT)
研究概览
简要总结
The purpose of the IVORY Study is to gather data to support global submissions/approvals for some models of the Ingenio device family.
详细描述
IVORY is a prospective, multi-center, randomized within-patient, single-blinded study to gather data to support Right Atrial Auto Threshold and RYTHMIQ
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Subjects who are willing and capable of providing informed consent to undergo a device implant and to participate in all testing associated with this clinical study;
- •Subjects whose age is 18 or above, or of legal age to give informed consent specific to national law;
- •Subjects indicated for a dual chamber pacemaker or a CRT-P device according to class I or class II indications of the standard ESC or ACC / AHA implant guidelines;
- •Subjects who are planned to be implanted with all leads intended for a specific device type (dual chamber pacemaker: atrial and right ventricular lead, CRT-P: atrial, right and left ventricular lead) or are already implanted with such leads;
- •Subjects who receive or are implanted with a bipolar atrial lead.
排除标准
- •Women of childbearing potential who are or might be pregnant at the time of the study (method of assessment upon physician's discretion);
- •Enrolled in any other concurrent study, with the exception of local mandatory governmental registries and observational studies/registries that are not in conflict or affect
- •Schedule of procedures for IVORY (i.e. should not cause additional or missed visits);
- •Programming of devices for IVORY per CIP;
- •IVORY outcome (i.e. involve medications that could affect the heart rate of the subject);
- •Conduct of IVORY per GCP / ISO 14 155:2011 / local regulations.
- •Subjects who live at such a distance from the clinic that travels for FU visits at a study center would be unusually difficult or burdensome for the subject;
- •Inability or refusal to comply with the FU schedule;
- •A life expectancy of less than 12 months, per physician discretion;
- •Subjects who are planned to be programmed to a pacing mode other than DDD / DDDR during the study period.
研究组 & 干预措施
Pacemaker - RYTHMIQ Off at Pre-discharge, On at 1-Month
For the RYTHMIQ endpoint only, subjects implanted with a pacemaker will be randomized. Those randomized to RYTHMIQ Off at Pre-Discharge will have RYTHMIQ programmed Off until their 1-month follow up, when they will be crossed over to RYTHMIQ On until their 3-month follow up.
干预措施: RAAT (Device)
Pacemaker - RYTHMIQ Off at Pre-discharge, On at 1-Month
For the RYTHMIQ endpoint only, subjects implanted with a pacemaker will be randomized. Those randomized to RYTHMIQ Off at Pre-Discharge will have RYTHMIQ programmed Off until their 1-month follow up, when they will be crossed over to RYTHMIQ On until their 3-month follow up.
干预措施: RYTHMIQ (Device)
Pacemaker - RYTHMIQ On at Pre-Discharge, Off at 1-Month
For the RYTHMIQ endpoint only, subjects implanted with a pacemaker will be randomized. Those randomized to RYTHMIQ On at Pre-Discharge will have RYTHMIQ programmed On until their 1-month follow up, when they will be crossed over to RYTHMIQ Off until their 3-month follow up.
干预措施: RAAT (Device)
Pacemaker - RYTHMIQ On at Pre-Discharge, Off at 1-Month
For the RYTHMIQ endpoint only, subjects implanted with a pacemaker will be randomized. Those randomized to RYTHMIQ On at Pre-Discharge will have RYTHMIQ programmed On until their 1-month follow up, when they will be crossed over to RYTHMIQ Off until their 3-month follow up.
干预措施: RYTHMIQ (Device)
CRT-P
CRT-P devices were not involved in RYTHMIQ endpoint evaluation, only RAAT.
干预措施: RAAT (Device)
结局指标
主要结局
Accuracy of Commanded Right Atrial Automatic Threshold (RAAT)
时间窗: 3 months post implant
Accuracy was evaluated by the proportion of tests resulting in an RAAT commanded threshold with \|Manual unipolar threshold - commanded threshold\| ≤ 0.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for purposes of endpoint analysis. A paired dataset consisted of the manual unipolar threshold and the commanded threshold obtained at a visit.
System-related Complication-free Rate
时间窗: 90 days post-implant
Arms/Groups are only applicable for the outcome measure 'Secondary Outcome: RYTHMIQ - Median Relative Reduction of RV Pacing Percent (RVPP) for RYTHMIQ Programmed to ON vs. RYTHMIQ Programmed to OFF'. This outcome measure was analyzed only for the combined population and both pacemakers and CRT-P devices were pooled for the analysis. The analysis assesses the system-related complication (SRC) -free rate (excluding LV related events for CRT-P subjects) for subjects implanted or attempted to be implanted with a study device through the first 90 days following the implant procedure.
次要结局
- RYTHMIQ - Median Relative Reduction of RV Pacing Percent (RVPP) for RYTHMIQ On at Pre-Discharge, Off at 1-Month vs. RYTHMIQ Off at Pre-discharge, On at 1-Month(3 months post implant)
- Accuracy of Ambulatory RAAT(3 months post-implant)
- Appropriate RAAT Test Outcome(3 months post-implant)
- Percentage of RAAT Threshold Tests With Sufficient RAAT Pace Output Margin(3 months post implant)