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Related Concept Videos

Clinical Trials01:16

Clinical Trials

8.5K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
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Clinical Trials: Overview01:11

Clinical Trials: Overview

4.7K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Preclinical Development: Overview01:28

Preclinical Development: Overview

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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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First Pass Effect01:12

First Pass Effect

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Presystemic elimination, or the first-pass effect, is the metabolism of drugs that reduces their effective concentration at the site of action. Apart from the first-pass effect, the systemic bioavailability of the drug is also reduced by other factors, including incomplete absorption or chemical degradation of drugs.
Depending on the route of administration, drugs can be metabolized in the liver, intestine, lungs, and vasculature. Orally administered drugs are first absorbed through the...
10.5K
Assessment of the Gastrointestinal System I: Subjective Data01:17

Assessment of the Gastrointestinal System I: Subjective Data

857
Assessing the gastrointestinal (GI) system is a complex process that begins with collecting subjective data. This data, collected through patient interviews, provides crucial insights into the patient's health history, perception patterns, and lifestyle habits, all contributing significantly to GI health.
Health History
The initial step in assessing the GI system is obtaining a comprehensive health history. This includes inquiring about the patient's history or presence of problems...
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Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

252
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
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Related Experiment Video

Updated: May 6, 2026

The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
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The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation

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Left Atrial Appendage Occlusion Using a Novel System: Preclinical Evaluation and First-in-Human Experience.

Felix Mahfoud1, Christian Ukena2, Philip D Adamson3

  • 1Department of Cardiology, University Heart Center, University Hospital Basel, Basel, Switzerland; Cardiovascular Research Institute Basel, University Heart Center, University Hospital Basel, Basel, Switzerland; Department of Biomedical Engineering, University Basel, Basel, Switzerland.

JACC. Cardiovascular Interventions
|October 25, 2025
PubMed
Summary

The Zenith left atrial appendage (LAA) occlusion system shows promising safety and effectiveness in preclinical and early human trials for preventing stroke in atrial fibrillation patients. This novel device achieved successful implantation and closure with no device-related thrombus, supporting further clinical investigation.

Keywords:
atrial fibrillationleft atrial appendage closurepreclinical modelstroke prevention

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Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
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Last Updated: May 6, 2026

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Use of a Percutaneous Ventricular Assist Device/Left Atrium to Femoral Artery Bypass System for Cardiogenic Shock
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Area of Science:

  • Cardiovascular Medicine
  • Medical Devices
  • Interventional Cardiology

Background:

  • Atrial fibrillation (AF) poses a significant stroke risk, with most clots originating in the left atrial appendage (LAA).
  • Oral anticoagulation is effective but not suitable for all AF patients.
  • Existing percutaneous LAA occlusion devices face challenges like device-related thrombus (DRT) and peridevice leak.

Purpose of the Study:

  • To evaluate the safety and performance of the novel Zenith LAA occlusion system.
  • Assessment included preclinical canine models and a prospective first-in-human (FIH) study.

Main Methods:

  • A multistage evaluation involved 3 preclinical canine trials (n=17) and a single-arm, prospective FIH study (n=10) in nonvalvular AF patients.
  • The Zenith system features a conformable Nitinol scaffold, a PET membrane, a self-closing conduit, and a dynamic anchoring system.
  • Primary follow-up included 45-day transesophageal echocardiography.

Main Results:

  • Preclinical explant analysis showed complete endothelialization with no DRT or significant inflammation at 45 days.
  • In the FIH study, 90% of patients (9/10) had successful implantation.
  • Primary safety and performance endpoints were achieved in 100% of patients (9/9), demonstrating acute procedural success, mechanical device closure, stable implants, and no DRT or serious adverse events at 45 days.

Conclusions:

  • The Zenith LAA occlusion system demonstrated favorable early safety and performance in preclinical and FIH evaluations.
  • Novel design features contributed to effective LAA sealing and the absence of DRT.
  • Results support further investigation of the Zenith system in larger clinical trials.