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| Sponsor: | CardioMEMS |
|---|---|
| Information provided by: | CardioMEMS |
| ClinicalTrials.gov Identifier: | NCT00531661 |
Purpose
This is a prospective, multi-center, randomized, single-blind clinical trial conducted in the United States (US). The objective of the study is to evaluate the safety and efficacy of the HF Pressure Measurement System in reducing heart failure (HF) related hospitalizations in a subset of subjects suffering from HF.
| Condition | Intervention |
|---|---|
|
Heart Failure, Congestive |
Device: HF Pressure Measurement System |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients |
| Estimated Enrollment: | 550 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
|
Device: HF Pressure Measurement System
A pressure sensor is intended to be implanted into the pulmonary artery at the time of Swan-Ganz catheterization.
|
|
2: Sham Comparator
CONTROL group: standard of care HF management
|
Device: HF Pressure Measurement System
A pressure sensor is intended to be implanted into the pulmonary artery at the time of Swan-Ganz catheterization.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contact sponsor for details.
Exclusion Criteria:
Contact sponsor for details.
Contacts and Locations| United States, Georgia | |
| CardioMEMS Investigational Sites | |
| Nationwide, Georgia, United States | |
| Principal Investigator: | Phillip Adamson, MD, FACC | Oklahoma Heart Hospital |
| Principal Investigator: | William T Abraham, MD, FACC | The Ohio State University Medical Center |
More Information
| Responsible Party: | CardioMEMS, Inc. ( Susan Neville, Clinical Project Manager ) |
| Study ID Numbers: | CM-06-04 |
| Study First Received: | September 18, 2007 |
| Last Updated: | February 5, 2010 |
| ClinicalTrials.gov Identifier: | NCT00531661 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Heart Failure Heart Diseases Cardiovascular Diseases |
