TandemHeart Experiences and MEthods (THEME Registry)

NCT02326402 | Terminated

• 1 other identifier: THEME
• Study Type: observational
• Target: 365
• Locations: 1 country
• Sites: 16

Brief 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

Keywords

Circulatory support; Extracorporeal circulatory support; Extracorporeal bypass; LifeSPARC

Outcome Measures

Primary Outcomes (1)

• Survival to Pump removal with myocardial and/or pulmonary recovery, durable ventricular assist device (VAD) implant or transition to another mechanical support device, or cardiac and/or lung transplant

  Survival

  180 Days

Secondary Outcomes (1)

• Occurrence of Serious Adverse Events (SAEs) related to the device while on support

  Approximately 72 hours after start of support

Interventions

TandemHeart or LifeSPARC System DEVICE

Percutaneous insertion of TandemHeart or LifeSPARC System

Also known as: TandemHeart, LifeSPARC System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in whom the System has been inserted percutaneously (e.g. in the cath lab or peri-operatively) for any diagnosis/condition at an institution participating in the THEME Registry (or transferred to an institution participating in the THEME Registry following insertion).

You may qualify if:

• Patient has had the TandemHeart or LifeSPARC System inserted percutaneously (e.g. in the cath lab or peri-operatively)
• Age \>= 18
• Patient (or legally authorized representative \[LAR\]) has signed informed consent

You may not qualify if:

• Patient is incarcerated (prisoner)
• Participation in a clinical trial of an investigational drug or device

Sponsors & Collaborators

• CardiacAssist, Inc.: lead

Study Sites (16)

Princeton-Baptist Medical Center

Birmingham, Alabama, 35233, United States

Location

Banner - University Medical Center Tucson

Tucson, Arizona, 85724, United States

Location

University of California, San Diego

La Jolla, California, 92037, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

St. John's Hospital

Springfield, Illinois, 62769, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

St. Louis University Hospital

St Louis, Missouri, 63110, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Providence Sacred Heart Medical Center & Children's Hospital

Spokane, Washington, 99204, United States

Location

Medical College of Wisconsin-Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• Rao P, Mosier J, Malo J, Dotson V, Mogan C, Smith R, Keller R, Slepian M, Khalpey Z. Peripheral VA-ECMO with direct biventricular decompression for refractory cardiogenic shock. Perfusion. 2018 Sep;33(6):493-495. doi: 10.1177/0267659118761558. Epub 2018 Feb 21.

  PMID: 29466925 DERIVED

MeSH Terms

Conditions

Heart Diseases; Lung Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: December 29, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

US (16)