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Related Concept Videos

Clinical Trials: Overview01:11

Clinical Trials: Overview

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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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Clinical Trials01:16

Clinical Trials

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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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Mitral Valve Prolapse II: Assessment and Management01:22

Mitral Valve Prolapse II: Assessment and Management

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IntroductionA range of clinical features characterizes Mitral Valve Prolapse (MVP), but it is important to note that many individuals with MVP are asymptomatic and may remain so throughout their lives. For those who do exhibit symptoms, the following are the key clinical features:Palpitations: This is a common symptom where individuals feel an irregular or rapid heartbeat. Palpitations in MVP are often due to arrhythmias such as premature ventricular contractions or supraventricular...
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Mitral Regurgitation I: Introduction01:20

Mitral Regurgitation I: Introduction

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Mitral regurgitation is characterized by the backward circulation of blood from the left ventricle to the left atrium during systole, a phase of the cardiac cycle when the heart contracts and pumps blood out of the chambers. This abnormal flow occurs primarily due to the dysfunction of the mitral valve or its supporting structures, which include the mitral leaflets, chordae tendineae, annulus, and papillary muscles.Etiology and Mechanisms:Primary Mitral Regurgitation: This type arises from...
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Mitral Regurgitation III: Medical Management01:25

Mitral Regurgitation III: Medical Management

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Mitral regurgitation (MR) is characterized by retrograde blood circulation from the left ventricle into the left atrium due to inadequate mitral valve closure. The severity of the condition, symptoms, and underlying cause determine treatment strategies.Monitoring and Pharmacological TreatmentPatients with mild to moderate MR typically do not need immediate intervention but regular monitoring to assess progression and guide treatment. Patients with mild MR should have an echocardiogram every 3-5...
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Mitral Valve Prolapse I: Introduction01:27

Mitral Valve Prolapse I: Introduction

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IntroductionThe mitral valve, one of the heart's four valves, regulates blood flow. These valves have flaps that open and close to direct blood properly through the heart and body. During each heartbeat, the flaps open for blood to pass through and seal shut to prevent backflow. Specifically, the mitral valve opens to allow blood flow from the heart's upper left chamber to the lower left chamber. It then closes securely as the lower left chamber contracts to pump blood to the body, preventing...
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Updated: Apr 19, 2026

A Simplified Stepwise Approach to Echo Guidance during Percutaneous Mitral Valve Repair
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The CoreValve US pivotal trial.

Colin M Barker1, Michael J Reardon2

  • 1Department of Cardiology, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.

Seminars in Thoracic and Cardiovascular Surgery
|December 21, 2014
PubMed
Summary

Transcatheter aortic valve replacement (TAVR) offers a less-invasive option for high-risk patients. Studies show TAVR achieved primary endpoints and demonstrated superior survival compared to surgery in specific patient groups.

Keywords:
CoreValveTAVRextreme riskhigh riskpivotal study

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Upper-extremity Approach for Secondary Access in Transfemoral Transcatheter Aortic Valve Implantation
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Upper-extremity Approach for Secondary Access in Transfemoral Transcatheter Aortic Valve Implantation

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Area of Science:

  • Cardiology
  • Interventional Cardiology
  • Medical Devices

Background:

  • Severe aortic stenosis poses significant risks for traditional surgery.
  • Transcatheter aortic valve replacement (TAVR) emerged as a less-invasive alternative.
  • The CoreValve system was evaluated in high- to extreme-risk patient cohorts.

Purpose of the Study:

  • To assess the safety and efficacy of transfemoral TAVR using the CoreValve system.
  • To evaluate TAVR outcomes in extreme-risk and high-risk patients with severe aortic stenosis.
  • To compare TAVR with surgical aortic valve replacement in high-risk patients.

Main Methods:

  • Enrollment of symptomatic severe aortic stenosis patients into extreme-risk and high-risk cohorts.
  • Transfemoral TAVR implantation using the CoreValve system.
  • The high-risk cohort underwent a randomized trial comparing TAVR to surgical aortic valve replacement.

Main Results:

  • In extreme-risk patients, TAVR met its primary endpoint of 1-year all-cause mortality or stroke.
  • Low stroke and paravalvular leak rates were observed, with improvement over time.
  • The high-risk trial demonstrated superior survival with TAVR versus surgical replacement, with fewer major strokes.

Conclusions:

  • Transfemoral TAVR with the CoreValve system is effective and safe for extreme-risk patients.
  • TAVR offers superior survival benefits compared to surgical aortic valve replacement in high-risk patients.
  • The CoreValve system shows promising results for managing severe aortic stenosis across different risk profiles.