ASCEND CSP IDE Study

Last updated: January 7, 2026
Sponsor: Abbott Medical Devices
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Heart Failure

Congestive Heart Failure

Treatment

LBBAP Implant with a CSP ICD Lead

Clinical Study ID

NCT06830746
ABT-CIP-10549
  • Ages 18-99
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  2. de novo Abbott ICD system implant (single or dual chamber)

  3. 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)

  4. Subject is ≥ 18 years of age or age of legal consent, whichever age is greater.

  5. 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.

  6. Subject is willing to comply with clinical investigation procedures and agrees toreturn to clinic for all required follow-up visits, tests, and exams.

  7. 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:

  1. Subject has had myocardial infarction or unstable angina within 40 days prior tosigning consent

  2. Subject has had recent cardiac revascularization (angioplasty, stent or bypassgraft) in the 4 weeks prior to signing consent or planned within 3 months followingconsent

  3. 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

  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 leadplacement (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 andwho 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 aninfection

  11. Subject is enrolled or planning to enroll in another clinical trial that mightconfound 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 theinterventricular 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 1for cardiac transplantation or consideration for transplantation during the studyfollow-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 diseasewithout 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 theirparticipation in the opinion of the investigator

Study Design

Total Participants: 414
Treatment Group(s): 1
Primary Treatment: LBBAP Implant with a CSP ICD Lead
Phase:
Study Start date:
April 11, 2025
Estimated Completion Date:
May 31, 2028

Connect with a study center

  • The Prince Charles Hospital

    Chermside, Queensland
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba, Queensland
    Australia

    Site Not Available

  • The Prince Charles Hospital

    Chermside 6943582, Queensland 2152274
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Woolloongabba 6943568, Queensland 2152274
    Australia

    Active - Recruiting

  • Royal Adelaide Hospital

    Adelaide, South Australia
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide 2078025, South Australia 2061327
    Australia

    Active - Recruiting

  • Monash Health

    Clayton, Victoria
    Australia

    Site Not Available

  • Monash Health

    Clayton 2171400, Victoria 2145234
    Australia

    Active - Recruiting

  • MUHC- Montreal General Hospital

    Montreal 6077243, H3G 1A4
    Canada

    Active - Recruiting

  • CHRU Hopital de Pontchaillou

    Rennes 2983990, Brittan 35033
    France

    Active - Recruiting

  • CHU Trousseau

    Chambray-lès-Tours 3027343, Centre-Val de Loire 3027939 37170
    France

    Active - Recruiting

  • Hôpital Pitié Salpetrière

    Paris 2988507, Ile 75013
    France

    Active - Recruiting

  • Prince of Wales Hospital

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Queen Mary Hospital

    Hong Kong,
    Hong Kong

    Site Not Available

  • Prince of Wales Hospital

    Hong Kong 1819729,
    Hong Kong

    Active - Recruiting

  • Queen Mary Hospital

    Hong Kong 1819729,
    Hong Kong

    Active - Recruiting

  • Max Super Specialty Hospital

    New Delhi, Delhi 110017
    India

    Site Not Available

  • Max Super Specialty Hospital

    New Delhi 1261481, National Capital Territory of Delhi 1273293 110017
    India

    Active - Recruiting

  • Sree Chitra Tirunal Institute for Medical Sciences & tech.

    Trivandrum 1254163, New Delhi 695-011
    India

    Active - Recruiting

  • Velammal Medical College Hospital

    Madurai, Tmlnadu 625009
    India

    Site Not Available

  • Velammal Medical College Hospital

    Madurai 1264521, Tmlnadu 625009
    India

    Active - Recruiting

  • Ospedale S.S. Annunziata

    Taranto 3165926, Apulia 3169778 74100
    Italy

    Active - Recruiting

  • Ospedale Niguarda Ca'Granda

    Milan 6951411, Lombard 20162
    Italy

    Active - Recruiting

  • National Heart Centre Singapore

    Singapore 1880252, Singapore 169609
    Singapore

    Active - Recruiting

  • Changi General Hospital

    Singapore,
    Singapore

    Active - Recruiting

  • National Heart Centre Singapore

    Singapore, 169609
    Singapore

    Site Not Available

  • Tan Tock Seng Hospital

    Singapore,
    Singapore

    Active - Recruiting

  • Changi General Hospital

    Singapore 1880252,
    Singapore

    Active - Recruiting

  • Tan Tock Seng Hospital

    Singapore 1880252,
    Singapore

    Active - Recruiting

  • Hospital Universitari i Politècnic La Fe

    Valencia 2509954, Valencia 2593113 46026
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de las Nieves

    Granada 2517117, 18014
    Spain

    Active - Recruiting

  • Hopital Cantonal Universitaire de Geneva

    Geneva 2660646, Canton of Geneva 2660645 1205
    Switzerland

    Active - Recruiting

  • Heart Center Research LLC

    Huntsville 4068590, Alabama 4829764 35801
    United States

    Active - Recruiting

  • Banner University Medical Center Phoenix

    Phoenix 5308655, Arizona 5551752 85006
    United States

    Active - Recruiting

  • Arrhythmia Research Group

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • Arrhythmia Research Group

    Jonesboro 4116834, Arkansas 4099753 72401
    United States

    Active - Recruiting

  • Premier Cardiology, Inc.

    Newport Beach 5376890, California 5332921 92663
    United States

    Active - Recruiting

  • University of California at San Diego (UCSD) Medical Center

    San Diego 5391811, California 5332921 92103
    United States

    Active - Recruiting

  • MedStar Washington Hospital Center

    Washington D.C. 4140963, District of Columbia 4138106 20010
    United States

    Active - Recruiting

  • AdventHealth Orlando

    Orlando 4167147, Florida 4155751 32803
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

  • New York Presbyterian Hospital/Cornell University

    New York 5128581, New York 5128638 10021
    United States

    Active - Recruiting

  • The Cleveland Clinic Foundation

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Active - Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Geisinger Medical Center

    Danville 5186327, Pennsylvania 6254927 17822
    United States

    Active - Recruiting

  • Lancaster General Hospital

    Lancaster 5197079, Pennsylvania 6254927 17602
    United States

    Active - Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Active - Recruiting

  • Erlanger Medical Center

    Chattanooga 4612862, Tennessee 4662168 37403
    United States

    Active - Recruiting

  • Sentara Norfolk General Hospital

    Norfolk 4776222, Virginia 6254928 23507
    United States

    Active - Recruiting

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