Patients in both groups were evaluated at three- and six-month
intervals using a variety of tests, including digital imaging and standard
quality of life measurement such as the six-minute walking test, New York
Heart Association (NYHA) heart failure classification and Minnesota Living
with Heart (MLHF) questionnaire. Final six-month results observed in the
SEISMIC Trial include:
-- 84 percent of treated patients experienced improved or unchanged
six-minute walking test scores compared to 16 percent of the control
- 69 percent of the control group's results worsened, versus only
16 percent of the treated group
-- 94 percent of treated patients experienced improved or unchanged NYHA
classification compared to 58 percent of the control group
- 42 percent of the control group's results worsened, versus only
6 percent of the treated group
Prof. Serruys also noted that reports of arrhythmia among the patients evaluated in SEISMIC, both in terms of total number of episodes as well as timing of episodes, were no different between the treatment and control arms in the study. This suggests that MyoCell is not associated with a higher prevalence of arrhythmias; rather, that arrhythmias are an expected occurrence for this subset of heart failure patients.
"These data support the need for a randomized, double-blind, placebo-controlled study involving the MyoCell technology," said Prof. Serruys. "We look forward to applying our learning from this trial to the larger, more comprehensive MARVEL(2) Trial currently underway in the U.S. and Europe."
The MARVEL Trial, a randomized, double-blind, placebo-controlled,
multi-center Phase II/III Trial involving 330 pati
|SOURCE Bioheart, Inc.|
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