Early Feasibility Study of Medtronic OmniaSecure Model 3930M Defibrillation Lead Implantation Via the Middle Cardiac Vein in Patients With Tricuspid Valve Regurgitation: MCV3930 EFS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Acute Procedural Success
研究概览
简要总结
Prospective, single center, early feasibility study designed to evaluate the initial safety and device performance of the Medtronic 3930M Lead when implanted via the Middle Cardiac Vein in patients with Tricuspid Valve Regurgitation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •Subject meets current clinical practice guidelines for implantation of ICD or CRT-D and will undergo one of the following:
- •Medtronic CRT-D system implant
- •Medtronic ICD system implant (single or dual chamber)
- •Anatomical suitability for middle cardiac vein lead placement based on pre procedural imaging.
- •Subject meets both of the following:
- •At least Moderate Tricuspid Valve Regurgitation documented by cardiac imaging
- •A clinical goal to avoid worsening tricuspid valve regurgitation as determined by the treating physician and/or the patient
- •Age 18 years or older.
- •Subject is willing to undergo implant defibrillation testing
- •Signed Patient Informed Consent Form (ICF).
排除标准
- •Life expectancy < 6 months due to non-cardiac comorbidities or advanced frailty where the procedure is not aligned with goals of care
- •Contraindication to transvenous lead implantation, including:
- •Severe or occlusive disease of the axillary/subclavian venous system
- •Coronary sinus or middle cardiac vein occlusion, severe stenosis, or anatomy prohibiting safe lead delivery
- •Known hypercoagulable state or bleeding disorder is not manageable with standard therapy.
- •Subject is contraindicated for ≤1 mg dexamethasone acetate
- •Patients with a medical condition that precludes them from undergoing defibrillation testing:
- •Pre-existing or suspected pneumothorax
- •Severe aortic stenosis
- •Current Intracardiac LA or LV thrombus
- •Severe proximal three-vessel or left main coronary artery disease without revascularization
- •Hemodynamic instability
- •Unstable angina
- •Recent stroke or transient ischemic attack (within the last 6 months)
- •Known inadequate external defibrillation
- •LVEDD >70 mm
- •Any other known medical condition not listed that precludes their participation in the opinion of the Investigator.
- •Patient with evidence of active infection or undergoing treatment for an infection.
- •Inability to provide informed consent, including:
- •Cognitive impairment without a legally authorized representative
- •Language or communication barriers that prevent adequate understanding of the study
- •Unable to follow through study protocol for any reasons (social support, distance from research center, insurance denial, mental illness etc.) in the investigator's judgement
- •Pregnant women or breastfeeding women, or women of childbearing potential and who are not on a reliable form of birth regulation method or abstinence
- •End-Stage Renal Disease (ESRD) on dialysis
- •Patient participation in another study that precludes concomitant study participation
研究组 & 干预措施
Interventional
Patients will undergo implant of the Medtronic 3930M Defibrillation lead via the Middle Cardiac Vein and undergo required electrical testing
干预措施: Defibrillator (Device)
结局指标
主要结局
Acute Procedural Success
时间窗: Index Procedure
Acute Procedural Success, defined as successful implantation of the investigational lead with all the following: 1. Successful lead delivery and deployment at the intended MCV location within 4 deployment attempts 2. Stable lead position at completion of the procedure 3. Acceptable electrical performance: * Capture threshold: ≤ 2.0 V at 0.4 ms * Sensing amplitude: ≥ 4.0 mV * Impedance: 200-1500 Ω 4. No device- or procedure-related Major Adverse Cardiovascular Events (MACE) through hospital discharge 5. Absence of T-wave Oversensing (TWOS) 6. Absence of P-wave Oversensing (PWOS) 7. Absence of Myopotential Oversensing 8. Successful Defibrillation Test (DFT) with 10J safety margin 9. Absence of any serious adverse events related to the MCV implantation site.
次要结局
- Lead Electrical Performance and Stability through 90 Days(Up to 90 days following implant)
- Incidence of Device- or Procedure-Related Complications(Up to 90 days following implant)
- Freedom from Device-or Procedure-Related Serious Adverse Events(Up to 90 days following implant)