NCT00000607

Brief Summary

To conduct a randomized, unblinded clinical trial comparing the left ventricular assist device (LVAD) with maximum medical management in patients with end-stage heart failure who were not candidates for heart transplantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at below P25 for phase_3 cardiovascular-diseases

Timeline
Completed

Started Oct 1997

Shorter than P25 for phase_3 cardiovascular-diseases

Geographic Reach
1 country

1 active site

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

October 1, 1997

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 1999

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 1999

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

December 23, 2015

Status Verified

December 1, 2015

Enrollment Period

1.4 years

First QC Date

October 27, 1999

Last Update Submit

December 22, 2015

Conditions

Cardiovascular DiseasesHeart DiseasesHeart FailureHeart Failure, Congestive

Outcome Measures

Primary Outcomes (1)

  • Survival rate in LVAD group

    2 years

Secondary Outcomes (1)

  • Survival rate in OMM group

    2 years

Study Arms (2)

Left ventricular assist device

EXPERIMENTAL

Subjects received Thermo Cardiosystems, Inc. (TCI) vented electric (VE) left ventricular assist device (LVAD) and were followed for at least two years

Device: Left ventricular assist device

Optimal medical therapy

ACTIVE COMPARATOR

Subjects received optimal medical therapy (OMM) and were followed for at least two years

Device: Optimal medical therapy

Interventions

Left ventricular assist deviceDEVICE

A type of implantable heart pump

Also known as: LVAD
Left ventricular assist device
Optimal medical therapyDEVICE

(non-experimental) One possibility in handling Heart failure effectively is optimal medicine therapy. The most popular treatment medications at present are ACE Inhibitors and Beta Blockers. The result is the heart being able to pump more effectively and allowing blood to circulate freely.

Also known as: OMM
Optimal medical therapy

Eligibility Criteria

Age18 Years - 72 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women with Class III and Class IV congestive heart failure
  • Between the ages of 18 and 72

You may not qualify if:

  • \. Candidates for heart transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

Related Publications (10)

  • Rose EA, Moskowitz AJ, Packer M, Sollano JA, Williams DL, Tierney AR, Heitjan DF, Meier P, Ascheim DD, Levitan RG, Weinberg AD, Stevenson LW, Shapiro PA, Lazar RM, Watson JT, Goldstein DJ, Gelijns AC. The REMATCH trial: rationale, design, and end points. Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure. Ann Thorac Surg. 1999 Mar;67(3):723-30. doi: 10.1016/s0003-4975(99)00042-9.

    PMID: 10215217BACKGROUND

  • Scalia GM, McCarthy PM, Savage RM, Smedira NG, Thomas JD. Clinical utility of echocardiography in the management of implantable ventricular assist devices. J Am Soc Echocardiogr. 2000 Aug;13(8):754-63. doi: 10.1067/mje.2000.105009.

    PMID: 10936819BACKGROUND

  • Sun BC, Catanese KA, Spanier TB, Flannery MR, Gardocki MT, Marcus LS, Levin HR, Rose EA, Oz MC. 100 long-term implantable left ventricular assist devices: the Columbia Presbyterian interim experience. Ann Thorac Surg. 1999 Aug;68(2):688-94. doi: 10.1016/s0003-4975(99)00539-1.

    PMID: 10475472BACKGROUND

  • Rose EA, Gelijns AC, Moskowitz AJ, Heitjan DF, Stevenson LW, Dembitsky W, Long JW, Ascheim DD, Tierney AR, Levitan RG, Watson JT, Meier P, Ronan NS, Shapiro PA, Lazar RM, Miller LW, Gupta L, Frazier OH, Desvigne-Nickens P, Oz MC, Poirier VL; Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) Study Group. Long-term use of a left ventricular assist device for end-stage heart failure. N Engl J Med. 2001 Nov 15;345(20):1435-43. doi: 10.1056/NEJMoa012175.

    PMID: 11794191BACKGROUND

  • Hunt SA. Comment--the REMATCH trial: Long-term use of a left ventricular assist device for end-stage heart failure. J Card Fail. 2002 Apr;8(2):59-60. doi: 10.1054/jcaf.2002.32944.

    PMID: 12016626BACKGROUND

  • Richenbacher WE, Naka Y, Raines EP, Frazier OH, Couper GS, Pagani FD, Damme L, VanMeter CH, Magovern GJ Jr, Gupta L, Seemuth SC, Weinberg AD, Long JW; REMATCH Investigators. Surgical management of patients in the REMATCH trial. Ann Thorac Surg. 2003 Jun;75(6 Suppl):S86-92. doi: 10.1016/s0003-4975(03)00485-5.

    PMID: 12820740BACKGROUND

  • Oz MC, Gelijns AC, Miller L, Wang C, Nickens P, Arons R, Aaronson K, Richenbacher W, van Meter C, Nelson K, Weinberg A, Watson J, Rose EA, Moskowitz AJ. Left ventricular assist devices as permanent heart failure therapy: the price of progress. Ann Surg. 2003 Oct;238(4):577-83; discussion 583-5. doi: 10.1097/01.sla.0000090447.73384.ad.

    PMID: 14530729BACKGROUND

  • Lazar RM, Shapiro PA, Jaski BE, Parides MK, Bourge RC, Watson JT, Damme L, Dembitsky W, Hosenpud JD, Gupta L, Tierney A, Kraus T, Naka Y. Neurological events during long-term mechanical circulatory support for heart failure: the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) experience. Circulation. 2004 May 25;109(20):2423-7. doi: 10.1161/01.CIR.0000129414.95137.CD. Epub 2004 May 3.

    PMID: 15123534BACKGROUND

  • Stevenson LW, Miller LW, Desvigne-Nickens P, Ascheim DD, Parides MK, Renlund DG, Oren RM, Krueger SK, Costanzo MR, Wann LS, Levitan RG, Mancini D; REMATCH Investigators. Left ventricular assist device as destination for patients undergoing intravenous inotropic therapy: a subset analysis from REMATCH (Randomized Evaluation of Mechanical Assistance in Treatment of Chronic Heart Failure). Circulation. 2004 Aug 24;110(8):975-81. doi: 10.1161/01.CIR.0000139862.48167.23. Epub 2004 Aug 16.

    PMID: 15313942BACKGROUND

  • Holman WL, Park SJ, Long JW, Weinberg A, Gupta L, Tierney AR, Adamson RM, Watson JD, Raines EP, Couper GS, Pagani FD, Burton NA, Miller LW, Naka Y; REMATCH Investigators. Infection in permanent circulatory support: experience from the REMATCH trial. J Heart Lung Transplant. 2004 Dec;23(12):1359-65. doi: 10.1016/j.healun.2003.09.025.

    PMID: 15607664BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesHeart Failure

Study Officials

  • Eric Rose, MD

    Retiree

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

October 1, 1997

Primary Completion

March 1, 1999

Study Completion

March 1, 1999

Last Updated

December 23, 2015

Record last verified: 2015-12

Locations

US(1)