NCT01568424

Brief Summary

The study objective is to gather post-market clinical data on the use of the CentriMag RVAS when used for temporary mechanical circulatory support of the right ventricle in patients with acute right ventricular failure from any cause

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 2, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

April 17, 2017

Completed
Last Updated

June 27, 2022

Status Verified

June 1, 2022

Enrollment Period

4.4 years

First QC Date

March 28, 2012

Results QC Date

March 3, 2017

Last Update Submit

June 23, 2022

Conditions

Right Ventricular Failure

Keywords

Heart FailureRight Ventricular FailureLevitronixThoratec Corporation

Outcome Measures

Primary Outcomes (1)

  • Survival

    In patients who recover and do not go on to transplantation or a long-term device: Survival to 30 days post-support or to hospital discharge (whichever is longer). In patients who do not recover and are bridged to transplant or a long-term system: Survival to induction of anesthesia for implantation of a long-term device or heart transplant.

    30 days post device removal

Secondary Outcomes (6)

  • Central Venous Pressure (CVP)

    Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal

  • Mean Arterial Pressure (MAP)

    Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal.

  • Cardiac Index (CI)

    Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal.

  • Blood Urea Nitrogen (BUN)

    Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal, 30 days after RVAD removal

  • Creatinine

    Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal, 30 days after RVAD removal

  • +1 more secondary outcomes

Study Arms (1)

Treatment Group

OTHER

Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.

Device: CentriMag RVAS placement

Interventions

CentriMag RVAS placementDEVICE

Patients will be treated with a CentriMag RVAS

Treatment Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Right ventricular failure from any cause

You may not qualify if:

  • Primary coagulopathy or platelet disorders
  • Allergy or sensitivity to heparin and all alternative anticoagulants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Mayo Clinic Hospital Arizona

Phoenix, Arizona, 85054, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

New York Columbia Presbyterian Hospital

New York, New York, 10032, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

St. Luke's Episcopal Medical Center

Houston, Texas, 77030, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Poornima Sood
Organization
St. Jude Medical
psood@sjm.com
+1.781.852.8334

Study Officials

  • Pooja Chatterjee

    Abbott Medical Devices

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2012

First Posted

April 2, 2012

Study Start

September 1, 2009

Primary Completion

February 1, 2014

Study Completion

June 1, 2014

Last Updated

June 27, 2022

Results First Posted

April 17, 2017

Record last verified: 2022-06

Locations

US(10)