Early Feasibility Study of Medtronic 3830 Lead Implantation Via the Middle Cardiac Vein in Patients With Prior or Planned Tricuspid Valve Intervention: MCV 3830 EFS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 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 3830 Lead when implanted via the Middle Cardiac Vein in patients with prior or planned tricuspid valve interventions.
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
- •Subjects who meet current clinical practice guidelines for implantation of a PPM or CRT-P system and will undergo one of the following procedures are eligible for enrollment, provided all inclusion and no
排除标准
- •Medtronic 3830 DDD pacing mode (dual-chamber pacemaker) OR
- •Medtronic 3830 VVI pacing mode (single-chamber ventricular pacemaker) OR
- •Medtronic 3830 CRT-P system implantation
- •Anatomical suitability for middle cardiac vein lead placement based on pre-procedural CT imaging.
- •Patient must have prior or planned tricuspid valve intervention, including any of the following:
- •Surgical tricuspid valve repair (e.g., annuloplasty ring, leaflet repair) OR
- •Surgical tricuspid valve replacement with a bioprosthetic or mechanical valve OR
- •Transcatheter tricuspid valve repair (e.g., edge-to-edge repair devices) OR
- •Transcatheter tricuspid valve replacement (orthotopic or heterotopic) OR
- •Patients with pre-existing transvalvular RV lead undergoing lead extraction for the management of tricuspid regurgitation who require reimplantation of a new ventricular pacing lead
- •A clinical need to avoid crossing the tricuspid valve, as determined by the treating heart team (e.g., risk of prosthesis-lead interaction, leaflet trauma, or the need to maintain a lead-free tricuspid valve)
- •Age 18 years or older.
- •Signed Patient Informed Consent Form (ICF).
- •Exclusion Criteria:
- •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 not manageable with standard therapy.
- •Subject is contraindicated for a single dose of 40.0 µg of beclomethasone dipropionate
- •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
研究组 & 干预措施
Interventional
Patients will undergo implant of the Medtronic Model 3830 pacemaker lead via the Middle Cardiac Vein and undergo required electrical testing
干预措施: Pacemaker (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 SelectSecure™ Model 3830 lead in the targeted proximal septal segment of the middle cardiac vein, absent of any serious adverse events related to the MCV implantation site, and achievement of the following: 1. Successful lead delivery and fixation at the intended MCV location using ≤ 4 deployment attempts 2. Stable lead position at completion of the implant procedure 3. Acceptable acute electrical performance, including: * Capture threshold ≤ 2.0 V at 0.4 ms * Sensing amplitude ≥ 4.0 mV * Lead impedance between 200-1500 Ω 4. No device- or procedure-related Major Adverse Cardiovascular Events (MACE) through hospital discharge 5. Absence of oversensing, including: * T-wave oversensing (TWOS) * P-wave oversensing (PWOS) * Myopotential oversensing * Diaphragm stimulation
次要结局
- Incidence of Device- or Procedure-Related Serious Adverse Events and Complications(Up to 90 days following implant)
- Lead Electrical Performance and Stability Through 12 Months(From Implant through 12 Months)
- Freedom From Device-or Procedure-Related Serious Adverse Events(Up to 90 days following implant)