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ACTIVE NOT RECRUITING NA

A Randomised Trial of S-ICD Implantation With and Without Defibrillation Testing

NCT03495297 · View on ClinicalTrials.gov ↗

Study Summary

This study will test the hypothesis that implantation of a subcutaneous implantable cardioverter defibrillator (S-ICD) without performing a defibrillation test is non-inferior to S-ICD implant with a defibrillation test with regards to the primary endpoint failed first shock in a spontaneous arrhythmia episode when implant position is confirmed with PRAETORIAN score.

Conditions Studied

Interventions

  • PROCEDURE ommitence of defibrillation testing

Study Locations (20)

Other

  • Asklepios Kliniken — Hamburg
  • Universitätsklinikum Schleswig-Holstein — Kiel
  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck — Lübeck
  • Universitätsklinikum Mannheim — Mannheim
  • Universitätsklinikum Würzburg — Würzburg
  • Flevoziekenhuis — Almere Stad
  • Academic Medical Center Amsterdam — Amsterdam
  • OLVG — Amsterdam
  • Albert Schweitzer Ziekenhuis — Dordrecht
  • Catharina Ziekenhuis — Eindhoven
  • UMCG — Groningen
  • Spaarne Gasthuis — Haarlem
  • Medisch Centrum Leeuwarden — Leeuwarden

New York

  • Mount Sinai Beth Israel — New York
  • Icahn School of Medicine at Mount Sinaï — New York

Florida

  • Adventh Health System — Orlando

Georgia

  • Emory University Hospital — Atlanta

Illinois

  • CorVita Science Foundation — Chicago

New Jersey

  • Englewood Hospital and Medical Center — Englewood

Tennessee

  • Erlanger Health System — Chattanooga

Trial Details

FieldValue
Enrollment Target 965 participants
Start Date 2018-05-07
Est. Completion 2025-07
Phase NA

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03495297

The ClinicalTrials.gov registry entry for NCT03495297 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 965 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), which has 33 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Ventricular Arrythmia appearing as the primary indexed condition, and to 1 intervention — of which ommitence of defibrillation testing is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03495297 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Other, New York, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03495297 about?

NCT03495297 is a clinical study titled "A Randomised Trial of S-ICD Implantation With and Without Defibrillation Testing". This study will test the hypothesis that implantation of a subcutaneous implantable cardioverter defibrillator (S-ICD) without performing a defibrillation test is non-inferior to S-ICD implant with a defibrillation test with regards to the primary endpoint failed first shock in a spontaneous arrhyth...

What is the current status of trial NCT03495297?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 965 participants. The study started on 2018-05-07. Estimated completion is 2025-07.

What conditions does trial NCT03495297 study?

This clinical trial studies the following conditions: Ventricular Arrythmia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03495297?

The interventions under investigation include: ommitence of defibrillation testing (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03495297?

This trial is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), which has 33 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03495297 being conducted?

This trial has 20 study locations across Florida, Georgia, Illinois, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial