Trial record 12 of 13 for:
ventricular assist device OR VAD OR BIVAD OR heart pump | Open Studies | NIH, U.S. Fed
Risk Stratification and Benefits With Cardiac Resynchronization Therapy (CRT) (BENEFIT)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by St. Jude Medical.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
St. Jude Medical
Collaborators:
Northwestern University
VA Pittsburgh Healthcare System
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00996086
First received: October 14, 2009
Last updated: April 4, 2011
Last verified: April 2011
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Purpose
This is an observational study to learn which patients benefit from CRT therapy and to track the clinical changes that help identify the risk-level of CRT patients.
| Condition | Intervention |
|---|---|
|
Heart Failure Ventricular Arrhythmias |
Device: CRT device implant |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Risk Stratification and Benefits With Cardiac Resynchronization Therapy |
Resource links provided by NLM:
Further study details as provided by St. Jude Medical:
Primary Outcome Measures:
- Change in 6-minute hall walk distance between baseline and subsequent follow-up [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Composite endpoint a. 6-minute hall walk distance b. NYHA Classification c. Quality of Life (Minnesota Living with Heart Failure, DASS, SF-36) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- The occurrence of either death (all-cause) or first HF hospitalization. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Change in echocardiographic variables including: a. Ejection Fraction b. Wall motion score c. Increase in TD velocity d. Yu index [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Cause-specific mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
There is a genetic substudy that will evaluate the presence of certain protein markers.
| Estimated Enrollment: | 150 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| CRT device-recipients |
Device: CRT device implant
CRT device-recipients
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
All patients who undergo implantation of a market-approved St. Jude Medical CRT defibrillator (CRT-D) and a compatible lead system may be included in the study.
Criteria
Inclusion Criteria:
- Meets current clinical indications for CRT-D therapy
- Patient is 18 years old or older
- Ability to independently comprehend and complete all QOL questionnaires
- Patient has the ability to perform the 6-minute Hall Walk Test (6-MHW) with the only limiting factor being fatigue or shortness-of-breath
- Ability to provide informed consent for a study and be willing and able to comply with the prescribed follow-up
Exclusion Criteria:
- Inability to successfully implant an intravascular lead and CRT-D device. (i.e. exclude epicardial leads) within 30 days of initial procedure.
- Myocardial infarction in the last 3 weeks
- Unstable angina in the last 3 weeks
- Status 1 classification for cardiac transplantation
- Currently participating in a clinical trial that includes an active treatment arm
- Life expectancy of less than 12 months.
- Recent (within 1 week) administration of Nesiritide™ or inotropes
- Patients in whom revascularization is expected
- Patient is pregnant
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00996086
Contacts
| Contact: Jasmina Halilovic | 408-522-6105 | jhalilovic@sjm.com |
| Contact: Manish S Gupta | 818 493 2608 | mgupta@sjm.com |
Locations
| United States, Illinois | |
| Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Alan Kadish, M.D. | |
| Contact: Karen Fachet, MS, RN 312.695.1914 | |
| United States, Pennsylvania | |
| Veterans' Adminstration Pittsburgh Healthcare System | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15240 | |
| Contact: Aala Shalaby, MD FACC 412-688-6176 Alaa.Shalaby@va.gov | |
Sponsors and Collaborators
St. Jude Medical
Northwestern University
VA Pittsburgh Healthcare System
Investigators
| Principal Investigator: | Alan Kadish, M.D. | Northwestern University |
| Principal Investigator: | Alaa Shalaby, M.D. | VA Pittsburgh Healthcare System |
More Information
No publications provided
| Responsible Party: | Director, Clinical Studies, St. Jude Medical |
| ClinicalTrials.gov Identifier: | NCT00996086 History of Changes |
| Other Study ID Numbers: | CRD 480 |
| Study First Received: | October 14, 2009 |
| Last Updated: | April 4, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Arrhythmias, Cardiac Heart Failure Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on June 17, 2013