Life-threatening ventricular tachyarrhythmias
Conditions
Interventions
- Implant MDT-1120 in LBBAP
- Required electrical for pacing, sensing, impedance and defibrillation will be completed
Sponsors
Goto Eiichiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subject meets current local clinical practice guidelines for implantation of ICD (single or dual chamber) or CRT-D system and will undergo one of the following: a)De novo Medtronic ICD system implant (single or dual chamber) or b)De novo Medtronic CRT-D system implant and is intended to also undergo LV lead implant (for patients indicated for CRT-D according to locally approved indications/guidelines) 2.Subject is 12 years of age or older and also is greater than 30 kg in weight at time of enrollment, has cardiac anatomy conducive to RV coil placement, and is allowed to participate in study per local law and requirements. Subjects from 12 years of age until adult also have a separate indication for pacing or CRT or are anticipated to develop one. 3.Subject provides written authorization and/or consent per institution and geographical requirements. 4.Subject is geographically stable and willing and able to complete the study procedures and visits for the duration of the follow-up 5.Subject is willing to undergo implant defibrillation testing if requested
Exclusion criteria
Exclusion criteria: 1.Subject has contraindication for screw-in active fixation transvenous lead placement (e.g., mechanical right heart valve) 2.Subject is contraindicated for 12 hours 12.Subjects with end stage renal disease 13.Subjects with NYHA IV classification 14.Subjects with a transplanted heart or on the waiting list for a heart transplant 15.Subjects with previously extracted leads 16.Subjects with Left Ventricular Assist Device 17.Subjects that are vulnerable adults
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Objective Demonstrate the percentage of patients successfully defibrillated at implant with the Next Generation ICD Lead when placed in the LBBAP location exceeds a pre-specified threshold of 88%. Primary Safety Objective Estimate the Next Generation ICD Lead-related major complication rate at 3-months post implant when the Next Generation ICD Lead implant is attempted in the LBBAP location. | — |
Secondary
| Measure | Time frame |
|---|---|
| Ancillary Objectives - Estimate the success rate of LBBAP Next Generation ICD Lead placement at implant. - Characterize pacing capture thresholds at a 0.4 ms pulse duration at implant and 3-months when the Next Generation ICD Lead is placed in the LBBAP location - Characterize R-wave sensing amplitude at implant and 3-months when the Next Generation ICD Lead is placed in the LBBAP location - Characterize pacing impedance at implant and 3-months when the Next Generation ICD Lead is placed in the LBBAP location - Characterize intrinsic (at implant) and paced (at implant and 6 months) ECG measurements - Characterize the change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline to 6 months For LOT-CRT implanted subjects only: - Characterize the change in Left Ventricular End-Systolic Volume Index (LVESVi) from baseline to 6 months - Characterize the change in Left Ventricular Ejection Fraction (LVEF) from baseline to 6 months - Characterize the Clinical Composite Score (CCS) when assessed at 6 months | — |
Countries
Australia, Belgium, Canada, China, France, Hong Kong, Japan, Malaysia, Netherlands, Poland, Spain, United Kingdom, United States
Contacts
Public ContactEiichiro Goto
Medtronic Japan
Outcome results
None listed