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TandemHeart Experiences and MEthods (THEME Registry)

NCT02326402 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 365

Last updated 2023-09-21

No results posted yet for this study

Summary

This study is intended to be a multicenter, prospective observation registry. By collecting prospective descriptive data, provide insight into disease defining characteristics resulting in the clinical decision to use TandemHeart® or LifeSPARC™ System for mechanical support and enhance knowledge of best practice regarding clinical management, weaning and removal/exit strategies.

Conditions

  • Heart Diseases
  • Lung Diseases

Interventions

DEVICE

TandemHeart or LifeSPARC System

Percutaneous insertion of TandemHeart or LifeSPARC System

Sponsors & Collaborators

  • CardiacAssist, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2022-12-31
Completion
2023-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02326402 on ClinicalTrials.gov