TandemHeart Experiences and MEthods (THEME Registry)

Sponsor

CardiacAssist, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT02326402

Collaborator

(none)

450

Enrollment

Locations

108

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Diseases Lung Diseases	Device: TandemHeart or LifeSPARC System

Detailed Description

The TandemHeart or LifeSPARC percutaneous extracorporeal life support system is used to support circulation. The percutaneous cannulas facilitate access to the venous and arterial circulatory vessels. When connected to the TandemHeart or LifeSPARC centrifugal pump, mechanical support is provided with sufficient cardiac power to perfuse the organs of the body.

It is anticipated that THEME Registry™ analysis will provide insight into disease defining characteristics resulting in the clinical decision to use the TandemHeart or LifeSPARC System for mechanical support and enhance knowledge of best practice regarding clinical management, weaning and removal. The progression of the illness prior to, during and following support will be collected. The THEME Registry will collect descriptive data regarding patient selection criteria and the clinical management of the patient including strategies used to wean and remove the device. Specifically the objectives of the THEME Registry are:

Summarize the characteristics of the patients who receive the System for temporary percutaneous mechanical support with or without an oxygenator, including demographics, pre-implant medical history, details of present illness, exit strategy.
Evaluate the timing of initiation of System support in relation to the progression of the presenting illness and the association of this with clinical outcomes.
Collect descriptive data related to clinical management of the patient while on mechanical support, including procedural details, duration of support, anticoagulation, hemodynamics and biochemical parameters to define trends in clinical care and the association of this decision-making with clinical outcomes.
Collect hospital discharge information including Intensive Care Unit (ICU) and Hospital length of stay (LOS).
Collect survival and exit strategy status at 30 and 180 days post-initial System insertion.
Collect serious adverse events from the time of Pump insertion through removal of the System (or Pump).
Provide data regarding patient characteristics and outcomes.

Study Design

Study Type:

Observational

Anticipated Enrollment :

450 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

THEME Registry: TandemHeart Experiences and MEthods (THEME Registry)

Study Start Date :

Dec 1, 2014

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Outcome Measures

Primary Outcome Measures

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 [180 Days]
Survival

Secondary Outcome Measures

Occurrence of Serious Adverse Events (SAEs) related to the device while on support [Approximately 72 hours after start of support]
Serious Adverse Events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Princeton-Baptist Medical Center	Birmingham	Alabama	United States	35233
2	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
3	Banner - University Medical Center Tucson	Tucson	Arizona	United States	85724
4	University of California, San Diego	La Jolla	California	United States	92037
5	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
6	St. John's Hospital	Springfield	Illinois	United States	62769
7	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
8	University of Michigan Health System	Ann Arbor	Michigan	United States	48109
9	Henry Ford Hospital	Detroit	Michigan	United States	48202
10	Mayo Clinic Hospital, Saint Marys Campus	Rochester	Minnesota	United States	55905
11	St. Louis University Hospital	Saint Louis	Missouri	United States	63110
12	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
13	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140
14	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
15	Baylor College of Medicine	Houston	Texas	United States	77030
16	University of Virginia Health System	Charlottesville	Virginia	United States	22908
17	Providence Sacred Heart Medical Center & Children's Hospital	Spokane	Washington	United States	99204
18	Medical College of Wisconsin-Froedtert Hospital	Milwaukee	Wisconsin	United States	53226