STandardized Ultra-conservative Or Physician-directed ICD Programming for Continuous Flow LVAD Support
Public ClinicalTrials.gov record NCT04264182. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
STandardized Ultra-conservative Or Physician-directed ICD Programming for SHOCK Reduction Among Patients on Continuous Flow LVAD Support: a Randomized Controlled Trial (STOP SHOCK LVAD Study)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will evaluate the utilization of an ultra-conservative programming strategy to reduce shocks for ventricular arrhythmias (VA) among patients with heart failure, an implantable cardioverter-defibrillator (ICD) and continuous flow (CF) left ventricular assist device (LVAD). Patients on LVAD support demonstrate unique hemodynamic tolerability of VA, and the role for ICDs among patients with newer generation CF LVADs remains less clear than the older generation devices. Prior studies have explored extended detection ICD programming to reduce unecessary or potentially avoidable shocks to patients. However, no prospective randomized study to-date has evaluated such programming strategies in the CF LVAD patient population. The study hypothesis is that ultra-conservative (UC) ICD programming will result in a reduction of shocks and an improvement in quality of life without increasing hospitalizations, syncope or death among patients on CF LVAD support, and the primary design is a 1:1 randomization between UC programming over standard, physician discretion programming.
Study identification
- NCT ID
- NCT04264182
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 11 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2, 2020
- Primary completion
- Apr 3, 2022
- Completion
- Apr 3, 2022
- Last update posted
- Jun 7, 2022
2020 – 2022
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04264182, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 7, 2022 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04264182 live on ClinicalTrials.gov.