Cardiovascular DiseasesPhase 3NCT00000607
Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH)
A Phase 3 study testing Left ventricular assist device and Optimal medical therapy in people with Cardiovascular Diseases and Heart Diseases, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Heart Failure
- What is being tested?
- Left ventricular assist device and Optimal medical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1997to Mar 1999
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women with Class III and Class IV congestive heart failure
- Between the ages of 18 and 72
Who cannot join
- 1. Candidates for heart transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The REMATCH Trial: Rationale, Design, and End Points. Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure
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.
Read the detailed description
BACKGROUND:
Mortality rates for heart failure are high, with five year survival rates approximating 30 to 40 percent in patients with mild to moderate symptoms and 0 to 20 percent survival in patients with severe symptoms. The patient with class IV heart failure has a one year survival rate of only 40 to 50 percent. This is despite advances in medical therapy and the availability of ACE inhibitors. While cardiac transplantation is the most viable form of treatment for these patients, it is limited by complications of chronic immunosuppression, the development of graft coronary artery disease and the serious shortage of donor organs. As many as 16,500 patients per year may be suitable candidates for heart transplantation. The actual number of donor hearts procured over the past few years, however, has remained relatively constant at 2,000. Thus, there is a strong rationale for the therapeutic application of left ventricular assist devices (LVADs) as an alternative to cardiac transplantation.
With respect to LVAD efficacy, patients have been supported for periods as long as 344 days on the pneumatic system and 503 days with the electromechanical device. Experience with the TCI pneumatic system in 75 LVAD patients show improved one year survival after transplantation in the LVAD patients as opposed to patients who did not receive the LVAD despite the same selection criteria. Experience with the vented electric LVADs in bridge patients show a transplant and survival rate that is similar to the pneumatic device. LVADs have also been shown to have a favorable effect on circulatory hemodynamics and exercise capacity. Among 53 patients who survived the TCI LVAD procedure, 90 percent improved to New York Heart Association (NYHA) functional class I and 10 percent to functional class II.
With respect to safety, the principal adverse effects associated with the LVADs include bleeding, hemolysis, and organ dysfunction, thromboembolism, infection, right heart failure, and mechanical failure. Thromboembolic complications are low in the TCI device despite the lack of systemic anticoagulation. The overall mechanical failure rate is small, less than 1 percent in 26 patient years of use. The vented electric and pneumatic device experience to date indicates that the devices are similar with respect to adverse event rates. Thus, in 1997 there was a strong rationale for a randomized controlled trial that compared the benefits and cost of vented electric LVADs to medical treatment. The need to perform a randomized controlled study was further emphasized by the lack of rigorous data on survival, quality of life, and cost effectiveness comparing LVAD support with medical therapy.
DESIGN NARRATIVE:
Unblinded, randomized, multicenter. Patients were randomized to either the Thermo Cardiosystems, Inc. (TCI) vented electric (VE) LVAD or optimal medical therapy (OMM) and followed for at least two years. If randomized to LVAD therapy, patients received a LVAD implantation within 12 hours of randomization. If randomized to medical therapy, patients received optimal medical management including the use of digoxin, diuretics, and ACE (Angiotensin Converting Enzyme) inhibitors in maximally tolerated doses. The primary endpoint was all-cause mortality. Secondary endpoints included cardiovascular mortality, exercise capacity (six-minute walk test) and health-related quality of life, adverse effects, and the relative cost-effectiveness of LVADs versus medical management. Recruitment ended in June, 2001.
- Being tested
- Left ventricular assist device, Optimal medical therapy
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left ventricular assist deviceDevice
Also called LVAD
A type of implantable heart pump
Optimal medical therapyDevice
Also called OMM
(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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Left ventricular assist device |
| Optimal medical therapy | Active comparator | Subjects received optimal medical therapy (OMM) and were followed for at least two years Receives: Device: Optimal medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate in LVAD group
Measured: 2 years
Secondary outcomes (1)
Survival rate in OMM group
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 1999 (estimated)
- Study startOct 1997
- Primary completionMar 1999
- Study completionMar 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Eric Rose, MD, Principal investigator, Retiree
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000607
- Sponsor's protocol ID
- CUMC ID unknown (110)
- Other IDs
- U01HL053986
- Status last verified
- Dec 2015
- First submitted
- 27 Oct 1999
- Last updated
- 23 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10215217Scalia 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.
PubMed 10936819Sun 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.
PubMed 10475472Rose 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.
PubMed 11794191Hunt 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.
PubMed 12016626Richenbacher 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.
PubMed 12820740Oz 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.
PubMed 14530729Lazar 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.
PubMed 15123534Stevenson 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.
PubMed 15313942Holman 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.
PubMed 15607664
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The REMATCH Trial: Rationale, Design, and End Points. Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT00000607
- Acronym / sponsor ID
- CUMC ID unknown (110)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 1997
- Primary completion
- Mar 1999 (actual)
- Study completion
- Mar 1999 (actual)
- First posted
- 28 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND:
Mortality rates for heart failure are high, with five year survival rates approximating 30 to 40 percent in patients with mild to moderate symptoms and 0 to 20 percent survival in patients with severe symptoms. The patient with class IV heart failure has a one year survival rate of only 40 to 50 percent. This is despite advances in medical therapy and the availability of ACE inhibitors. While cardiac transplantation is the most viable form of treatment for these patients, it is limited by complications of chronic immunosuppression, the development of graft coronary artery disease and the serious shortage of donor organs. As many as 16,500 patients per year may be suitable candidates for heart transplantation. The actual number of donor hearts procured over the past few years, however, has remained relatively constant at 2,000. Thus, there is a strong rationale for the therapeutic application of left ventricular assist devices (LVADs) as an alternative to cardiac transplantation.
With respect to LVAD efficacy, patients have been supported for periods as long as 344 days on the pneumatic system and 503 days with the electromechanical device. Experience with the TCI pneumatic system in 75 LVAD patients show improved one year survival after transplantation in the LVAD patients as opposed to patients who did not receive the LVAD despite the same selection criteria. Experience with the vented electric LVADs in bridge patients show a transplant and survival rate that is similar to the pneumatic device. LVADs have also been shown to have a favorable effect on circulatory hemodynamics and exercise capacity. Among 53 patients who survived the TCI LVAD procedure, 90 percent improved to New York Heart Association (NYHA) functional class I and 10 percent to functional class II.
With respect to safety, the principal adverse effects associated with the LVADs include bleeding, hemolysis, and organ dysfunction, thromboembolism, infection, right heart failure, and mechanical failure. Thromboembolic complications are low in the TCI device despite the lack of systemic anticoagulation. The overall mechanical failure rate is small, less than 1 percent in 26 patient years of use. The vented electric and pneumatic device experience to date indicates that the devices are similar with respect to adverse event rates. Thus, in 1997 there was a strong rationale for a randomized controlled trial that compared the benefits and cost of vented electric LVADs to medical treatment. The need to perform a randomized controlled study was further emphasized by the lack of rigorous data on survival, quality of life, and cost effectiveness comparing LVAD support with medical therapy.
DESIGN NARRATIVE:
Unblinded, randomized, multicenter. Patients were randomized to either the Thermo Cardiosystems, Inc. (TCI) vented electric (VE) LVAD or optimal medical therapy (OMM) and followed for at least two years. If randomized to LVAD therapy, patients received a LVAD implantation within 12 hours of randomization. If randomized to medical therapy, patients received optimal medical management including the use of digoxin, diuretics, and ACE (Angiotensin Converting Enzyme) inhibitors in maximally tolerated doses. The primary endpoint was all-cause mortality. Secondary endpoints included cardiovascular mortality, exercise capacity (six-minute walk test) and health-related quality of life, adverse effects, and the relative cost-effectiveness of LVADs versus medical management. Recruitment ended in June, 2001.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left ventricular assist device | Experimental | Device: Left ventricular assist deviceSubjects received Thermo Cardiosystems, Inc. (TCI) vented electric (VE) left ventricular assist device (LVAD) and were followed for at least two years |
| Optimal medical therapy | Active comparator | Device: Optimal medical therapySubjects received optimal medical therapy (OMM) and were followed for at least two years |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women with Class III and Class IV congestive heart failure
- Between the ages of 18 and 72
Key exclusion criteria (1 listed)
- 1. Candidates for heart transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Left ventricular assist deviceAlso: LVADA type of implantable heart pump | Device | Left ventricular assist device |
| Optimal medical therapyAlso: OMM(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. | Device | Optimal medical therapy |
Primary outcome
Survival rate in LVAD group
Time frame: 2 years
1 secondary outcome
Survival rate in OMM group
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2015.
- Background: PubMed 10215217Rose 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.
- Background: PubMed 10936819Scalia 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.
- Background: PubMed 10475472Sun 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.
- Background: PubMed 11794191Rose 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.
- Background: PubMed 12016626Hunt 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.
- Background: PubMed 12820740Richenbacher 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.
- Background: PubMed 14530729Oz 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.
- Background: PubMed 15123534Lazar 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.
- Background: PubMed 15313942Stevenson 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.
- Background: PubMed 15607664Holman 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.
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Rose, MD principal investigator
Retiree
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Left ventricular assist device and Optimal medical therapy in people with Cardiovascular Diseases and Heart Diseases, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate in LVAD group (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000607, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2015.