ASCEND CSP IDE Study

Running, not enrolling · Not applicable

Conditions studied: Heart Failure, Ventricular Arrythmia

In brief

This is a prospective, multi-center, global, single-arm, pivotal investigational study designed to evaluate the safety and effectiveness of the CSP ICD Lead in a subject population indicated for ICD or CRT-D therapy. The clinical investigation will enroll up to 414 subjects at up to 70 participating centers from the United States, Canada, Europe, and Asia Pacific.

Key facts

Study ID: NCT06830746
Run by: Abbott Medical Devices
People needed: 414
Starts: 2025-04-11
Expected to finish: 2028-05-01
Last updated by the study team: 2026-03-18

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject must meet current clinical practice guidelines for implantation of ICD or CRT-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 left ventricle coronary sinus lead implant (for patients indicated for CRT-D according 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. Subjects with AF in whom defibrillation testing is required must have been on or willing to be on uninterrupted anticoagulation therapy before, during, and after the implant procedure.
Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams.
Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC.

You may not qualify if…

Subject has had myocardial infarction or unstable angina within 40 days prior to signing consent
Subject has had recent cardiac revascularization (angioplasty, stent or bypass graft) in the 4 weeks prior to signing consent or planned within 3 months following consent
Subject has had any other therapeutic cardiovascular procedure (such as transcatheter aortic valve replacement, MitraClip, cardiac surgery, left atrial appendage 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 lead placement (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 and who 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 an infection
Subject is enrolled or planning to enroll in another clinical trial that might confound the results of the present study
Subject has moderate or severe aortic stenosis
Subject has ventricular septal defect (VSD) or had prior surgery on the interventricular 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 1 for cardiac transplantation or consideration for transplantation during the study follow-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 disease without revascularization
Subject has Ejection Fraction less than 20%
Subject has recent stroke or transient ischemic attack (within the last 6 months)

Where it is running

Heart Center Research LLC — Huntsville, Alabama, United States
Banner University Medical Center Phoenix — Phoenix, Arizona, United States
Arrhythmia Research Group — Jonesboro, Arkansas, United States
Premier Cardiology, Inc. — Newport Beach, California, United States
University of California at San Diego (UCSD) Medical Center — San Diego, California, United States
MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
AdventHealth Orlando — Orlando, Florida, United States
Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
New York Presbyterian Hospital/Cornell University — New York, New York, United States
The Cleveland Clinic Foundation — Cleveland, Ohio, United States
Geisinger Medical Center — Danville, Pennsylvania, United States
Lancaster General Hospital — Lancaster, Pennsylvania, United States
Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Erlanger Medical Center — Chattanooga, Tennessee, United States
Medical City Dallas Hospital — Dallas, Texas, United States
Sentara Norfolk General Hospital — Norfolk, Virginia, United States
The Prince Charles Hospital — Chermside, Queensland, Australia
Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
Royal Adelaide Hospital — Adelaide, South Australia, Australia
Monash Health — Clayton, Victoria, Australia
MUHC- Montreal General Hospital — Montreal, Canada
CHRU Hopital de Pontchaillou — Rennes, Brittan, France
CHU Trousseau — Chambray-lès-Tours, Centre-Val de Loire, France
Hôpital Pitié Salpetrière — Paris, Ile, France
Prince of Wales Hospital — Hong Kong, Hong Kong

Full record on ClinicalTrials.gov

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