Defibrillator, Tricuspid Valve Regurgitation
Conditions
Brief summary
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
Interventions
DEVICEDefibrillator
Required electrical testing for pacing, sensing, impedance, and defibrillation will be completed
Sponsors
Minneapolis Heart Institute Foundation
Cara Medical Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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) 2. Anatomical suitability for middle cardiac vein lead placement based on pre procedural imaging. 3. 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 4. Age 18 years or older. 5. Subject is willing to undergo implant defibrillation testing 6. Signed Patient Informed Consent Form (ICF).
Exclusion criteria
1. Life expectancy \< 6 months due to non-cardiac comorbidities or advanced frailty where the procedure is not aligned with goals of care 2. 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. 3. Subject is contraindicated for ≤1 mg dexamethasone acetate 4. 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. 5. Patient with evidence of active infection or undergoing treatment for an infection. 6. Inability to provide informed consent, including: * Cognitive impairment without a legally authorized representative * Language or communication barriers that prevent adequate understanding of the study 7. 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 8. Pregnant women or breastfeeding women, or women of childbearing potential and who are not on a reliable form of birth regulation method or abstinence 9. End-Stage Renal Disease (ESRD) on dialysis 10. NYHA IV 11. Patient participation in another study that precludes concomitant study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Procedural Success | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lead Electrical Performance and Stability through 90 Days | Up to 90 days following implant | Evaluation of MCV lead electrical performance and stability through 90 days following implantation, including: * Stability of electrical performance (e.g., pacing threshold, sensing, impedance) * Lead stability (e.g., no dislodgement or migration) * Need for lead revision or system modification |
| Incidence of Device- or Procedure-Related Complications | Up to 90 days following implant | Number of participants experiencing device- or procedure-related complications through 90 days following implantation: 1\. Incidence of device- or procedure-related major adverse events including, but not limited to: * Death (all-cause or procedure-related) * Cardiac perforation, pericardial effusion, or cardiac tamponade * Clinically significant arrhythmia requiring intervention * Device-related infection requiring intervention * Lead dislodgement requiring intervention * Coronary sinus or venous injury * Clinically significant phrenic nerve stimulation * System revision or extraction |
| Freedom from Device-or Procedure-Related Serious Adverse Events | Up to 90 days following implant | Proportion of participants free from device-or procedure-related serious adverse events through 90 days following implantation. |
Countries
United States
Contacts
CONTACTEfrah M Hussein, BS
CONTACTDawn R Witt, PhD
PRINCIPAL_INVESTIGATORJohn S Zakaib, MD
Minneapolis Heart Institute Foundation
Outcome results
None listed