Cardiomems
Protocol Number: CM-06-04
Therapeutic Area: Cardiology
Summary:
Determine reduction of hospitalization related to disease progression with Heart Failure Pressure Measurement System to treat heart failure patient. CardioMEMS is an implantable intravascular pressure sensor. Implanted in the pulmonary vessel during right heart catheterization. By providing Systolic, Diastolic, and Mean pressure readings as well as Cardiac Output readings along with cardiac wave forms, the physician is able to monitor a patient remotely via web based link with patients home based reading device. This allows the physician to adjust patient’s medications before increasing heart failure symptoms are present reducing incidents of hospitalization for heart failure.
Inclusion Criteria:
- NYHA – Class III
- At least 1 HF hospitalization in last 12 months.
- Stable on HF medications for past 30 days prior to enrollment.
- BMI <35
Exclusion Criteria:
- GFR <30
- History of recurrent (> 1) pulmonary embolism or deep vein thrombosis
- CRT / ICD implant <3 mo. Prior
- Likely to undergo heart transplant <6mo
- Known coagulation disorder
- Allergy to ASA or Plavix
* Additional Eligibility Criteria Exist *
Center Name: Mercy Research Institute at Mercy Hospital
Contact Information: Mercy Research Institute Clinical Trial Coordinators
Address: 3659 South Miami Avenue, Suite 3001, Miami, Florida 33133
Phone: (305) 854-4400, ext. 2312
Fax: (305) 285-2791
E-mail: rhumphreys@mercymiami.org