Phase
Condition
Chest Pain
Heart Failure
Congestive Heart Failure
Treatment
LBBAP Implant with a CSP ICD Lead
Clinical Study ID
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject must meet current clinical practice guidelines for implantation of ICD orCRT-D and will undergo one of the following:
de novo Abbott ICD system implant (single or dual chamber)
de novo Abbott CRT-D system implant and is intended to also undergo leftventricle coronary sinus lead implant (for patients indicated for CRT-Daccording to locally approved indications)
Subject is ≥ 18 years of age or age of legal consent, whichever age is greater.
Subject is willing to undergo implant defibrillation testing if requested. Subjectswith AF in whom defibrillation testing is required must have been on or willing tobe on uninterrupted anticoagulation therapy before, during, and after the implantprocedure.
Subject is willing to comply with clinical investigation procedures and agrees toreturn to clinic for all required follow-up visits, tests, and exams.
Subject has been informed of the nature of the clinical investigation, agrees to itsprovisions and has provided a signed written informed consent, approved by theIRB/EC.
Exclusion
Exclusion Criteria:
Subject has had myocardial infarction or unstable angina within 40 days prior tosigning consent
Subject has had recent cardiac revascularization (angioplasty, stent or bypassgraft) in the 4 weeks prior to signing consent or planned within 3 months followingconsent
Subject has had any other therapeutic cardiovascular procedure (such astranscatheter aortic valve replacement, MitraClip, cardiac surgery, left atrialappendage closure, patent foramen ovale closure, or any ablation procedures) in the 3 months prior to signing consent or planned within 3 months following consent
Subject has had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months of prior to signing consent
Subject has a life expectancy of less than 12 months
Subject has contraindications for standard RV transvenous and/or LBBAP leadplacement (e.g., mechanical right heart valve)
Subject is contraindicated for ≤1mg Dexamethasone sodium phosphate.
Subject is pregnant or breastfeeding women, or women of childbearing potential andwho are not on a reliable form of birth regulation method or abstinence
Subject has an existing pacemaker (including a temporary pacing system), ICD, CRT,or cardiac contractility modulation (CCM) device or leads
Subject has any evidence of active infection or undergoing treatment for aninfection
Subject is enrolled or planning to enroll in another clinical trial that mightconfound the results of the present study
Subject has moderate or severe aortic stenosis
Subject has ventricular septal defect (VSD) or had prior surgery on theinterventricular septum that could impact LBBAP implant, such as septal myomectomy,ethanol septal ablation, VSD repair, etc
Subject has end-stage renal disease
Subject has NYHA IV classification
Subject has undergone cardiac transplantation or have a classification of Status 1for cardiac transplantation or consideration for transplantation during the studyfollow-up period
Subject has had previously extracted leads
Subject has had an LV Assist Device
Subject has had a failed LBBAP lead implant
Defibrillation testing exclusion criteria (these are part of general exclusion criteria when defibrillation testing is requested):
Subject has pre-existing or suspected pneumothorax during implant
Subject has current known intracardiac left atrial or Left Ventricular thrombus
Subject has severe proximal three-vessel or left main coronary artery diseasewithout revascularization
Subject has Ejection Fraction less than 20%
Subject has recent stroke or transient ischemic attack (within the last 6 months)
Subject has known inadequate external defibrillation
Subject has any other known medical condition not listed that precludes theirparticipation in the opinion of the investigator
Study Design
Connect with a study center
The Prince Charles Hospital
Chermside, Queensland
AustraliaActive - Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland
AustraliaActive - Recruiting
Royal Adelaide Hospital
Adelaide, South Australia
AustraliaActive - Recruiting
Monash Health
Clayton, Victoria
AustraliaActive - Recruiting
Prince of Wales Hospital
Hong Kong,
Hong KongActive - Recruiting
Queen Mary Hospital
Hong Kong,
Hong KongActive - Recruiting
Changi General Hospital
Singapore,
SingaporeActive - Recruiting
Tan Tock Seng Hospital
Singapore,
SingaporeActive - Recruiting
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