Next Generation INCEPTA ICD and CRT-D Field Following Study: Respiratory Rate Trend Evaluation in Heart Failure (HF) Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Clinical Performance at Implant for Right Ventricle (RV) Sensing Amplitude
研究概览
简要总结
This study has 2 purposes:
The first purpose of the study is to test a new family of Boston Scientific Implantable Cardioverter Defibrillators ("ICDs") and cardiac resynchronization therapy ICDs ("CRT-Ds") and show how well these new devices work in patients. This new family is called the INCEPTA ICD and the INCEPTA CRT-D.
The second purpose of the study is to collect data from a feature that monitors breathing. It is called the Respiratory Rate Trend (RRT). These data will help to better understand how changes in breathing relate to changes in clinical conditions.
详细描述
Study Purpose
Study purpose I:
To evaluate and document appropriate clinical performance of the INCEPTA (DR and VR) implantable cardioverter defibrillator (ICD) system and the INCEPTA cardiac resynchronization therapy ICD (CRT-D) system and associated application software.
Study purpose II:
Demonstrate the clinical relevance of chronic ambulatory daily median Respiratory Rate Trend (RRT) in HF patients
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patients who are willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical study;
- •Patients whose age is 18 or above, or of legal age to give informed consent specific to national law
- •Patients indicated for an ICD according to normal clinical practice (for those patients receiving an INCEPTA ICD).
- •As soon as 20 ICD patients are included in the study for purpose I, only NYHA Class III patients will be allowed in the study.
- •New York Heart Association (NYHA) Class III patients indicated for a CRT-D according to normal clinical practice (for those patients receiving an INCEPTA CRT-D).
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.
- •Inability or refusal to comply with the follow-up schedule
- •Patients that have received routinely scheduled intravenous inotropic therapy as part of their drug regimen within the past 90 days
- •Patients prescribed to positive airway pressure therapy
- •A life expectancy of less than 1 year, per physician discretion
- •Patient in NYHA Class IV during the last 4 weeks
结局指标
主要结局
Clinical Performance at Implant for Right Ventricle (RV) Sensing Amplitude
时间窗: implant
RV Sensed Amplitude results were reported at implant for CRT-D and ICD patients
Clinical Performance for Left Ventricular (LV) Sensing Amplitude at Implant for CRT-D Patients
时间窗: implant
Left Ventricular (LV) Sensed Amplitude results were reported at implant for CRT-D patients.
Clinical Performance at Pre-discharge for LV Sensing Amplitude for CRT-D Patients
时间窗: pre-discharge
Left Ventricular (LV) Sensed Amplitude results were reported pre-discharge for CRT-D patients.
Clinical Performance at1-month for Left Ventricular (LV) Sensing Amplitude for CRT-D Patients
时间窗: 1-month
LV Sensed Amplitude results were reported at 1-month post-implant for CRT-D patients.
Clinical Performance at Implant for Right Atrium (RA) Sensing Amplitude
时间窗: implant
RA Sensed Amplitude results were reported for implant for CRT-D and ICD patients
Clinical Performance at Pre-discharge for RA Sensing Amplitude
时间窗: pre-discharge
RA Sensed Amplitude results were reported at pre-discharge for CRT-D and ICD patients
Clinical Performance at1-month for RA Sensing Amplitude
时间窗: 1-month
RA Sensed Amplitude results were reported at 1-month post-implant for CRT-D and ICD patients
Clinical Performance at Pre-discharge for Right Ventricle (RV) Sensing Amplitude
时间窗: pre-discharge
RV Sensed Amplitude results were reported at pre-discharge for CRT-D and ICD patients
Clinical Performance at1-month for Right Ventricle (RV) Sensing Amplitude
时间窗: 1month
RV Sensed Amplitude results were reported at 1-month post-implant for CRT-D and ICD patients
Clinical Performance at Implant for LV Pacing Threshold
时间窗: implant
LV pacing threshold results were reported for CRT-D patients at implant.
Clinical Performance at Pre-discharge for LV Pacing Threshold
时间窗: pre-discharge
LV pacing threshold results were reported at pre-discharge for CRT-D patients.
Clinical Performance at1-month for LV Pacing Threshold
时间窗: 1-month
LV pacing threshold results were reported at 1-month post-implant for CRT-D patients.
Clinical Performance at Implant for RV Pacing Threshold
时间窗: implant
RV pacing threshold results were reported at implant
Clinical Performance at Pre-discharge for RV Pacing Threshold
时间窗: pre-discharge
RV pacing threshold results were reported at pre-discharge
Clinical Performance at 1-month for RV Pacing Threshold
时间窗: 1-month
RV pacing threshold results were reported at 1-month post-implant
Clinical Performance at Implant for RA Pacing Threshold
时间窗: implant
RA pacing threshold results were reported for implant
Clinical Performance at Pre-discharge for RA Pacing Threshold
时间窗: pre-discharge
RA pacing threshold results were reported at pre-discharge
Clinical Performance at 1-month for RA Pacing Threshold
时间窗: 1-month
RA pacing threshold results were reported at 1-month post-implant
Clinical Performance at Implant LV Pacing Impedance for CRT-D.
时间窗: implant
LV pacing impedance results at implant were measured in CRT-D.
Clinical Performance at Pre-discharge for LV Pacing Impedance for CRT-D.
时间窗: pre-discharge
LV pacing impedance results were reported for pre-discharge visit
Clinical Performance at 1-month for LV Pacing Impedance for CRT-D.
时间窗: 1-month
LV pacing impedance results were reported at 1-month post-implant
Clinical Performance at Implant for RV Pacing Impedance
时间窗: implant
RV pacing impedance results were reported at implant
Clinical Performance at Pre-discharge for RV Pacing Impedance
时间窗: pre-discharge
RV pacing impedance results were reported for pre-discharge
Clinical Performance at 1-month for RV Pacing Impedance
时间窗: 1-month
RV pacing impedance results were reported at 1-month post-implant
Clinical Performance at Implant for RA Pacing Impedance
时间窗: implant
RA pacing impedance results were reported at implant
Clinical Performance at Pre-discharge for RA Pacing Impedance
时间窗: pre-discharge
RA pacing impedance results were reported at pre-discharge
Clinical Performance at 1-month for RA Pacing Impedance
时间窗: 1-month
RA pacing impedance results were reported at 1-month post-implant
Product Experiences Reported by the Site for All Patients for Study Duration
时间窗: Overall study results
Product experiences reported may include the shock impedance noise display, problems encountered with the universal serial bus (USB), a program parameter mismatch, reverse mode switches, electrogram (EGM) noise without oversensing, lead connection issues, or customer device feedback.
Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episode Successful Conversion Rates at Implant
时间窗: implant
The % of successful conversions after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. All episodes of induced VT/VF that resolved with successful conversion were counted from the total attempted conversions and reported as the % of successful conversions from those attempted.
Induced VT/VF Episode Successful Conversion Rates at 1-month
时间窗: 1-month
The % of successful conversions after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. All episodes of induced VT/VF that resolved with successful conversion were counted from the total attempted conversions and reported as the % of successful conversions from those attempted.
Induced VT/VF Episode Successful Conversion Rates at 3-months
时间窗: 3-month
The % of successful conversions after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. All episodes of induced VT/VF that resolved with successful conversion were counted from the total attempted conversions and reported as the % of successful conversions from those attempted.
Induced Episode Detection Times at Implant
时间窗: implant
The mean time it took to complete a successful conversion after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. The time was recorded (in seconds) for the time duration that was required to successfully convert the patient after inducing VT/VF.
Induced Episode Detection Times at 1-month
时间窗: 1-month
The mean time it took to complete a successful conversion after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. The time was recorded (in seconds) for the time duration that was required to successfully convert the patient after inducing VT/VF.
Induced Episode Detection Times at 3 Months
时间窗: 3-month
The mean time it took to complete a successful conversion after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. The time was recorded (in seconds) for the time duration that was required to successfully convert the patient after inducing VT/VF.
Spontaneous Episode Conversion Success Rate at 3 Months
时间窗: 3-month
Of the total patients that experienced a spontaneous episode, the % of patients with a spontaneous rhythm conversion that was successful was determined.
Wanded Telemetry Issues at Pre-discharge Follow-up
时间窗: Pre-Discharge visit occurred after implant but prior to 1 month follow-up visit
The Investigators completed a questionnaire based on the performance of the wanded telemetry during device interrogations at pre-discharge follow-up. The number of problems reported were counted from the entire study cohort.
次要结局
- Evaluate the Daily Median Respiratory Rate Trend in Patients Who Experience a HF-event Compared to Patients Who do Not Experience a HF-event.(Results were captured from implant time window to the first event for patients with HFE, up to an average of 9 months)