ASCEND CSP

ASCEND CSP
Enrolling By Invitation
18 years - 99 years
All
Phase N/A
12 participants needed
1 Location

Brief description of 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. 

Detailed description of study

The trial aims to study if the investigational CSP ICD Lead is safe and effective in treating adults with heart conditions who need an implantable cardioverter defibrillator (ICD or CRT-D) system. Participants will have data collected at baseline, implant procedure, pre-discharge, and follow-up at 3 months, 6 months, and every 6 months thereafter until site closure. The total duration of the clinical study is expected to be approximately 1.5 years, including enrollment and data collection.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Medical Research
  • Age: 18 years - 99 years
  • Gender: All

Inclusion Criteria:

  • 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
  • Subject is willing to undergo implant defibrillation testing if requested.

Exclusion Criteria:

  • 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, cardiac surgery, 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

Updated on 02 Apr 2026. Study ID: 25-1472
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Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

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