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
AustraliaSite Not Available
Princess Alexandra Hospital
Woolloongabba, Queensland
AustraliaSite Not Available
The Prince Charles Hospital
Chermside 6943582, Queensland 2152274
AustraliaActive - Recruiting
Princess Alexandra Hospital
Woolloongabba 6943568, Queensland 2152274
AustraliaActive - Recruiting
Royal Adelaide Hospital
Adelaide, South Australia
AustraliaSite Not Available
Royal Adelaide Hospital
Adelaide 2078025, South Australia 2061327
AustraliaActive - Recruiting
Monash Health
Clayton, Victoria
AustraliaSite Not Available
Monash Health
Clayton 2171400, Victoria 2145234
AustraliaActive - Recruiting
MUHC- Montreal General Hospital
Montreal 6077243, H3G 1A4
CanadaActive - Recruiting
CHRU Hopital de Pontchaillou
Rennes 2983990, Brittan 35033
FranceActive - Recruiting
CHU Trousseau
Chambray-lès-Tours 3027343, Centre-Val de Loire 3027939 37170
FranceActive - Recruiting
Hôpital Pitié Salpetrière
Paris 2988507, Ile 75013
FranceActive - Recruiting
Prince of Wales Hospital
Hong Kong,
Hong KongActive - Recruiting
Queen Mary Hospital
Hong Kong,
Hong KongSite Not Available
Prince of Wales Hospital
Hong Kong 1819729,
Hong KongActive - Recruiting
Queen Mary Hospital
Hong Kong 1819729,
Hong KongActive - Recruiting
Max Super Specialty Hospital
New Delhi, Delhi 110017
IndiaSite Not Available
Max Super Specialty Hospital
New Delhi 1261481, National Capital Territory of Delhi 1273293 110017
IndiaActive - Recruiting
Sree Chitra Tirunal Institute for Medical Sciences & tech.
Trivandrum 1254163, New Delhi 695-011
IndiaActive - Recruiting
Velammal Medical College Hospital
Madurai, Tmlnadu 625009
IndiaSite Not Available
Velammal Medical College Hospital
Madurai 1264521, Tmlnadu 625009
IndiaActive - Recruiting
Ospedale S.S. Annunziata
Taranto 3165926, Apulia 3169778 74100
ItalyActive - Recruiting
Ospedale Niguarda Ca'Granda
Milan 6951411, Lombard 20162
ItalyActive - Recruiting
National Heart Centre Singapore
Singapore 1880252, Singapore 169609
SingaporeActive - Recruiting
Changi General Hospital
Singapore,
SingaporeActive - Recruiting
National Heart Centre Singapore
Singapore, 169609
SingaporeSite Not Available
Tan Tock Seng Hospital
Singapore,
SingaporeActive - Recruiting
Changi General Hospital
Singapore 1880252,
SingaporeActive - Recruiting
Tan Tock Seng Hospital
Singapore 1880252,
SingaporeActive - Recruiting
Hospital Universitari i Politècnic La Fe
Valencia 2509954, Valencia 2593113 46026
SpainActive - Recruiting
Hospital Universitario Virgen de las Nieves
Granada 2517117, 18014
SpainActive - Recruiting
Hopital Cantonal Universitaire de Geneva
Geneva 2660646, Canton of Geneva 2660645 1205
SwitzerlandActive - Recruiting
Heart Center Research LLC
Huntsville 4068590, Alabama 4829764 35801
United StatesActive - Recruiting
Banner University Medical Center Phoenix
Phoenix 5308655, Arizona 5551752 85006
United StatesActive - Recruiting
Arrhythmia Research Group
Jonesboro, Arkansas 72401
United StatesSite Not Available
Arrhythmia Research Group
Jonesboro 4116834, Arkansas 4099753 72401
United StatesActive - Recruiting
Premier Cardiology, Inc.
Newport Beach 5376890, California 5332921 92663
United StatesActive - Recruiting
University of California at San Diego (UCSD) Medical Center
San Diego 5391811, California 5332921 92103
United StatesActive - Recruiting
MedStar Washington Hospital Center
Washington D.C. 4140963, District of Columbia 4138106 20010
United StatesActive - Recruiting
AdventHealth Orlando
Orlando 4167147, Florida 4155751 32803
United StatesActive - Recruiting
Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215
United StatesActive - Recruiting
New York Presbyterian Hospital/Cornell University
New York 5128581, New York 5128638 10021
United StatesActive - Recruiting
The Cleveland Clinic Foundation
Cleveland 5150529, Ohio 5165418 44195
United StatesActive - Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Geisinger Medical Center
Danville 5186327, Pennsylvania 6254927 17822
United StatesActive - Recruiting
Lancaster General Hospital
Lancaster 5197079, Pennsylvania 6254927 17602
United StatesActive - Recruiting
Hospital of the University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesActive - Recruiting
Erlanger Medical Center
Chattanooga 4612862, Tennessee 4662168 37403
United StatesActive - Recruiting
Sentara Norfolk General Hospital
Norfolk 4776222, Virginia 6254928 23507
United StatesActive - Recruiting

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