ventricular tachyarrhythmias
Conditions
Interventions
Please see visit schedule overview in CIP section 9.2, table 7
Enrollment/Baseline visit - Visit 1
- Physical Exam - a general exam that will include height and weight
- Demographics: including age,
Sponsors
Medtronic B.V.
Eligibility
Age
18 Years to 64 Years
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/indications*) 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 *CRT-D indications in the U.S. are based on Class I and II indications per current AHA/ACC/HFSA Guideline
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 **If required by local law, individuals who are of child-bearing potential must undergo a pregnancy test within seven days prior to study procedures
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 LBBAP location exceeds a pre-specified threshold of 88%. Successful implant defibrillation is defined as: • First induced SSVA episode successfully terminated with an 18J or maximum output minus 10 Joule (M-10J) shock, or • First therapy of the second induced SSVA episode successfully terminated with a M-10J shock, or • First therapy after a system reposition of an induced SSVA episode successfully terminated with a M-10J shock, or • Two consecutively induced SSVA episodes successfully terminated with a M-10J shock. 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
Netherlands
Outcome results
None listed