Lead EvaluAtion for Defibrillation and Reliability

JRCT ID: jRCT2072210078

Registered date:18/10/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Life-threatening ventricular tachyarrhythmias
• Date of first enrollment: 05/11/2021
• Target sample size: 25
• Countries of recruitment: United States,Japan,Australia,Japan,Canada,Japan,China,Japan,Austria,Japan,Denmark,Japan,France,Japan,Germany,Japan,Italy,Japan,Portugal,Japan,Serbia,Japan,Spain,Japan,United Kingdom,Japan,Hong Kong,Japan,Malaysia,Japan,Singapore,Japan,Puerto Rico,Japan
• Study type: Interventional
• Intervention(s): Perform the ICD and CRT-D treatment using the MDT-1120 lead.

Outcome(s)

Primary Outcome

Primary Safety Objective: Demonstrate that the freedom from major complications related to the Next Generation ICD lead at 6 months postimplant exceeds a pre-specified threshold of 90%.

Primary Efficacy Objective: Demonstrate the percentage of patients successfully defibrillated at implant with the Next Generation ICD lead exceeds a prespecified threshold of 88%.

• Secondary Outcome: The secondary objective (safety) is to estimate the fracture-free rate of the Next Generation ICD Lead throughout the study duration

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Subject meets current clinical practice guidelines for ICD or CRT-D implantation and will undergo one of the following:
- de novo Medtronic CRT-D system implant
- de novo Medtronic ICD system implant (single or dual chamber)
2.Subject has, per local law and requirements, the minimum age for autonomously signing an ICF
3.Subject is willing to undergo implant defibrillation testing if requested.
4.Subject is geographically stable and willing and able to complete the study procedures and visits for the duration of the follow-up.

Exclude criteria

1.Subject is unwilling or unable to personally provide Informed Consent.
2.Subject has contraindications for standard RV transvenous lead placement (e.g., mechanical right heart valve).
3.Subject is contraindicated for <= 1 mg dexamethasone acetate.
4.Subject has a life expectancy of less than 12 months
5.Subject is unable to undergo defibrillation testing due to physician judgement or medical conditions such as
- Pre-existing or suspected pneumothorax during implant
- Current intracardiac left atrial or left ventricular (LV) thrombus
- Severe aortic stenosis
- Severe proximal three-vessel or left main coronary artery disease without revascularization
- Unstable angina
- Ejection Fraction less than 25%
- 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
6.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.
7.Subject with any exclusion criteria as required by local law (e.g., age or other).
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.Subject with an existing pacemaker (including transcatheter pacing system), ICD, or CRT device or leads
10.Subject with any evidence of active infection or undergoing treatment for an infection
11.Recent (or planned) cardiac surgery or stenting less than 1 month before implant
12.End stage renal disease
13.Subjects with NYHA IV classification
14.Subjects with a transplanted heart
15.Subjects with a history of extracted leads
16.16. Subjects with Left Ventricular Assist Device

Related Information

• Primary Sponsor: Yamamoto Takuto
• Secondary ID(s): NCT04863664