Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)

JRCT ID: jRCT2072240047

Registered date:08/08/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Life-threatening ventricular tachyarrhythmias
• Date of first enrollment: 30/09/2024
• Target sample size: 20
• Countries of recruitment: United States,Japan,Canada,Japan,United Kingdom,Japan,Belgium,Japan,France,Japan,Poland,Japan,Netherlands,Japan,Spain,Japan,Australia,Japan,Malaysia,Japan,Hong Kong,Japan,China,Japan
• Study type: Interventional

Intervention(s)

- Implant MDT-1120 in LBBAP
- Required electrical for pacing, sensing, impedance and defibrillation will be completed

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude criteria

1.Subject has contraindication for screw-in active fixation transvenous lead placement (e.g., mechanical right heart valve)
2.Subject is contraindicated for <=1 mg dexamethasone acetate
3.Subject has a life expectancy of less than 12 months
4.For subject undergoing defibrillation testing the following medical conditions exclude them:
- Pre-existing or suspected pneumothorax
- Current intracardiac left atrial or LV thrombus
- Severe aortic stenosis
- Severe proximal three-vessel or left main coronary artery disease without revascularization
- Unstable angina
- Recent stroke or transient ischemic attack (within the last 6 months)
- Known inadequate external defibrillation
- Any other known medical condition not listed that precludes their participation in the opinion of the investigator
5.Subject is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager
6.Subject with any exclusion criteria as required by local law (e.g., age or other)
7.Subject is pregnant or breastfeeding, or subject is of childbearing potential and not on a reliable form of birth regulation method or abstinence
8.Subject with an existing pacemaker (including transvenous and transcatheter pacing system), ICD (transvenous) or CRT-D (transvenous) device or leads
9.Subject with previous subcutaneous ICD (S-ICD), extravascular ICD (EV ICD) or Implantable Cardiac Monitor explanted within 30 days before implant
10.Subject with any evidence of active bacterial infection or undergoing treatment for a bacterial infection within the last 30 days
11.Recent (or planned) cardiovascular intervention within 30 days before or after implant, such as cardiac surgery, cardiac ablation, Percutaneous Coronary Intervention (PCI), or temporary cardiac pacing 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

Related Information

• Primary Sponsor: Goto Eiichiro
• Secondary ID(s): NCT04863664