Phase
Condition
Chest Pain
Congestive Heart Failure
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
AustraliaSite Not Available
Princess Alexandra Hospital
Woolloongabba 6943568, Queensland 2152274
AustraliaSite Not Available
Royal Adelaide Hospital
Adelaide, South Australia
AustraliaSite Not Available
Royal Adelaide Hospital
Adelaide 2078025, South Australia 2061327
AustraliaSite Not Available
Monash Health
Clayton, Victoria
AustraliaSite Not Available
Monash Health
Clayton 2171400, Victoria 2145234
AustraliaSite Not Available
MUHC- Montreal General Hospital
Montreal, H3G 1A4
CanadaSite Not Available
MUHC- Montreal General Hospital
Montreal 6077243, H3G 1A4
CanadaSite Not Available
CHRU Hopital de Pontchaillou
Rennes, Brittan 35033
FranceSite Not Available
CHRU Hopital de Pontchaillou
Rennes 2983990, Brittan 35033
FranceSite Not Available
CHU Trousseau
Chambray-lès-Tours, Centre-Val de Loire 37170
FranceSite Not Available
CHU Trousseau
Chambray-lès-Tours 3027343, Centre-Val de Loire 3027939 37170
FranceSite Not Available
Hôpital Pitié Salpetrière
Paris, Ile 75013
FranceSite Not Available
Hôpital Pitié Salpetrière
Paris 2988507, Ile 75013
FranceSite Not Available
Prince of Wales Hospital
Hong Kong,
Hong KongSite Not Available
Queen Mary Hospital
Hong Kong,
Hong KongSite Not Available
Prince of Wales Hospital
Hong Kong 1819729,
Hong KongSite Not Available
Queen Mary Hospital
Hong Kong 1819729,
Hong KongSite Not Available
Max Super Specialty Hospital
New Delhi, National Capital Territory of Delhi 110017
IndiaSite Not Available
Max Super Specialty Hospital
New Delhi 1261481, National Capital Territory of Delhi 1273293 110017
IndiaSite Not Available
Sree Chitra Tirunal Institute for Medical Sciences & tech.
Trivandrum, New Delhi 695-011
IndiaSite Not Available
Sree Chitra Tirunal Institute for Medical Sciences & tech.
Trivandrum 1254163, New Delhi 695-011
IndiaSite Not Available
Velammal Medical College Hospital
Madurai, Tmlnadu 625009
IndiaSite Not Available
Velammal Medical College Hospital
Madurai 1264521, Tmlnadu 625009
IndiaSite Not Available
Ospedale S.S. Annunziata
Taranto, Apulia 74100
ItalySite Not Available
Ospedale S.S. Annunziata
Taranto 3165926, Apulia 3169778 74100
ItalySite Not Available
ASST Grande Ospedale Metropolitano Niguarda
Milan, Lombard 20162
ItalySite Not Available
Ospedale Niguarda Ca'Granda
Milan 6951411, Lombard 20162
ItalySite Not Available
National Heart Centre Singapore
Singapore 1880252, Singapore 169609
SingaporeSite Not Available
Changi General Hospital
Singapore,
SingaporeSite Not Available
National Heart Centre Singapore
Singapore, 169609
SingaporeSite Not Available
Tan Tock Seng Hospital
Singapore,
SingaporeSite Not Available
Changi General Hospital
Singapore 1880252,
SingaporeSite Not Available
Tan Tock Seng Hospital
Singapore 1880252,
SingaporeSite Not Available
Hospital Universitari i Politècnic La Fe
Valencia 2509954, Valencia 2593113 46026
SpainSite Not Available
Hospital Universitario Virgen de las Nieves
Granada, 18014
SpainSite Not Available
Hospital Universitario Virgen de las Nieves
Granada 2517117, 18014
SpainSite Not Available
Hospital Universitari i Politècnic La Fe
Valencia, 46026
SpainSite Not Available
Hopital Cantonal Universitaire de Geneva
Geneva 2660646, Canton of Geneva 2660645 1205
SwitzerlandSite Not Available
Hôpitaux Universitaires de Genève
Geneva, 1205
SwitzerlandSite Not Available
Heart Center Research LLC
Huntsville, Alabama 35801
United StatesSite Not Available
Heart Center Research LLC
Huntsville 4068590, Alabama 4829764 35801
United StatesSite Not Available
Banner University Medical Center Phoenix
Phoenix, Arizona 85006
United StatesSite Not Available
Banner University Medical Center Phoenix
Phoenix 5308655, Arizona 5551752 85006
United StatesSite Not Available
Arrhythmia Research Group
Jonesboro, Arkansas 72401
United StatesSite Not Available
Arrhythmia Research Group
Jonesboro 4116834, Arkansas 4099753 72401
United StatesSite Not Available
Premier Cardiology, Inc.
Newport Beach, California 92663
United StatesSite Not Available
University of California at San Diego (UCSD) Medical Center
San Diego, California 92103
United StatesSite Not Available
Premier Cardiology, Inc.
Newport Beach 5376890, California 5332921 92663
United StatesSite Not Available
University of California at San Diego (UCSD) Medical Center
San Diego 5391811, California 5332921 92103
United StatesSite Not Available
MedStar Washington Hospital Center
Washington D.C., District of Columbia 20010
United StatesSite Not Available
MedStar Washington Hospital Center
Washington D.C. 4140963, District of Columbia 4138106 20010
United StatesSite Not Available
AdventHealth Orlando
Orlando, Florida 32803
United StatesSite Not Available
AdventHealth Orlando
Orlando 4167147, Florida 4155751 32803
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215
United StatesSite Not Available
New York Presbyterian Hospital/Cornell University
New York, New York 10021
United StatesSite Not Available
New York Presbyterian Hospital/Cornell University
New York 5128581, New York 5128638 10021
United StatesSite Not Available
The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesSite Not Available
The Cleveland Clinic Foundation
Cleveland 5150529, Ohio 5165418 44195
United StatesSite Not Available
Geisinger Medical Center
Danville, Pennsylvania 17822
United StatesSite Not Available
Lancaster General Hospital
Lancaster, Pennsylvania 17602
United StatesSite Not Available
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Geisinger Medical Center
Danville 5186327, Pennsylvania 6254927 17822
United StatesSite Not Available
Lancaster General Hospital
Lancaster 5197079, Pennsylvania 6254927 17602
United StatesSite Not Available
Hospital of the University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available
Erlanger Medical Center
Chattanooga, Tennessee 37403
United StatesSite Not Available
Erlanger Medical Center
Chattanooga 4612862, Tennessee 4662168 37403
United StatesSite Not Available
Medical City Dallas Hospital
Dallas, Texas 75230
United StatesSite Not Available
Medical City Dallas Hospital
Dallas 4684888, Texas 4736286 75230
United StatesSite Not Available
Sentara Norfolk General Hospital
Norfolk, Virginia 23507
United StatesSite Not Available
Sentara Norfolk General Hospital
Norfolk 4776222, Virginia 6254928 23507
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.