ASCEND CSP IDE Study

Last updated: May 22, 2025
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

    Active - Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, Queensland
    Australia

    Active - Recruiting

  • Royal Adelaide Hospital

    Adelaide, South Australia
    Australia

    Active - Recruiting

  • Monash Health

    Clayton, Victoria
    Australia

    Active - Recruiting

  • Prince of Wales Hospital

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Queen Mary Hospital

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Changi General Hospital

    Singapore,
    Singapore

    Active - Recruiting

  • Tan Tock Seng Hospital

    Singapore,
    Singapore

    Active - Recruiting

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