ASCEND CSP IDE Study (ASCEND CSP IDE)

A Stylet-Driven ICD Lead Intended for Conduction System Pacing IDE Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure; Ventricular Arrythmia
• Intervention / Treatment: Device: LBBAP Implant with a CSP ICD Lead

• Study Type: Interventional
• Enrollment (Estimated): 414
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Chermside, Queensland, Australia
      • The Prince Charles Hospital
    • Woolloongabba, Queensland, Australia
      • Princess Alexandra Hospital
  • South Australia
    • Adelaide, South Australia, Australia
      • Royal Adelaide Hospital
  • Victoria
    • Clayton, Victoria, Australia
      • Monash Health
• Canada
  • Montreal, Canada, H3G 1A4
    • MUHC- Montreal General Hospital
• France
  • Brittan
    • Rennes, Brittan, France, 35033
      • CHRU Hôpital de Pontchaillou
  • Centre-Val de Loire
    • Chambray-lès-Tours, Centre-Val de Loire, France, 37170
      • CHU Trousseau
  • Ile
    • Paris, Ile, France, 75013
      • Hopital Pitie Salpetriere
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital
• India
  • National Capital Territory of Delhi
    • New Delhi, National Capital Territory of Delhi, India, 110017
      • MAX Super Specialty Hospital
  • New Delhi
    • Trivandrum, New Delhi, India, 695-011
      • Sree Chitra Tirunal Institute for Medical Sciences & tech.
  • Tmlnadu
    • Madurai, Tmlnadu, India, 625009
      • Velammal Medical College Hospital
• Italy
  • Apulia
    • Taranto, Apulia, Italy, 74100
      • Ospedale S.S. Annunziata
  • Lombard
    • Milan, Lombard, Italy, 20162
      • ASST Grande Ospedale Metropolitano Niguarda
• Singapore
  • Singapore, Singapore, 169609
    • National Heart Centre Singapore
  • Singapore, Singapore
    • Tan Tock Seng Hospital
  • Singapore, Singapore
    • Changi General Hospital
• Spain
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de Las Nieves
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe
• Switzerland
  • Geneva, Switzerland, 1205
    • Hôpitaux Universitaires de Genève
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Heart Center Research LLC
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner University Medical Center Phoenix
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Arrhythmia Research Group
  • California
    • Newport Beach, California, United States, 92663
      • Premier Cardiology, Inc.
    • San Diego, California, United States, 92103
      • University of California at San Diego (UCSD) Medical Center
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Medstar Washington Hospital Center
  • Florida
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • New York
    • New York, New York, United States, 10021
      • New York Presbyterian Hospital/Cornell University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Lancaster, Pennsylvania, United States, 17602
      • Lancaster General Hospital
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Medical Center
  • Texas
    • Dallas, Texas, United States, 75230
      • Medical City Dallas Hospital
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subject must meet current clinical practice guidelines for implantation of ICD or CRT-D and will undergo one of the following:

   1. de novo Abbott ICD system implant (single or dual chamber)
   2. 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)
2. Subject is ≥ 18 years of age or age of legal consent, whichever age is greater.
3. 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.
4. Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams.
5. 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.

Exclusion Criteria:

1. Subject has had myocardial infarction or unstable angina within 40 days prior to signing consent
2. 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
3. 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
4. Subject has had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months of prior to signing consent
5. Subject has a life expectancy of less than 12 months
6. Subject has contraindications for standard RV transvenous and/or LBBAP lead placement (e.g., mechanical right heart valve)
7. Subject is contraindicated for ≤1mg Dexamethasone sodium phosphate.
8. 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
9. Subject has an existing pacemaker (including a temporary pacing system), ICD, CRT, or cardiac contractility modulation (CCM) device or leads
10. Subject has any evidence of active infection or undergoing treatment for an infection
11. Subject is enrolled or planning to enroll in another clinical trial that might confound the results of the present study
12. Subject has moderate or severe aortic stenosis
13. 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
14. Subject has end-stage renal disease
15. Subject has NYHA IV classification
16. 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
17. Subject has had previously extracted leads
18. Subject has had an LV Assist Device
19. Subject has had a failed LBBAP lead implant

Defibrillation testing exclusion criteria (these are part of general exclusion criteria when defibrillation testing is requested):

1. Subject has pre-existing or suspected pneumothorax during implant
2. Subject has current known intracardiac left atrial or Left Ventricular thrombus
3. Subject has severe proximal three-vessel or left main coronary artery disease without revascularization
4. Subject has Ejection Fraction less than 20%
5. Subject has recent stroke or transient ischemic attack (within the last 6 months)
6. Subject has known inadequate external defibrillation
7. Subject has any other known medical condition not listed that precludes their participation in the opinion of the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Subjects undergoing ICD/CRT implant will be implanted with the CSP ICD Lead in the LBBAP location and undergo required electrical testing	Device: LBBAP Implant with a CSP ICD Lead; Required electrical testing for pacing, sensing, impedance and defibrillation will be completed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Endpoint	Freedom from CSP ICD Lead-related Serious Adverse Device Effects (SADEs) through 3 months post-implant for subjects in which the CSP ICD Lead implant was attempted	3 months post-implant
Primary Effectiveness Endpoint 1	3-month composite success rate of acceptable pacing capture thresholds and R-wave sense amplitudes of the CSP ICD Leads in the subjects with the CSP ICD Lead implanted at the LBBA	3-months post-implant
Primary Effectiveness Endpoint 2	Success rate of the defibrillation testing at implant in the subjects who complete the defibrillation test with the CSP ICD Lead implanted at the LBBA	at implant

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2025
• Primary Completion (Actual): January 29, 2026
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: February 12, 2025
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): February 17, 2025

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: ICD; lead; conduction system pacing; CRT-D; LBBAP
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: ABT-CIP-10549

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No