dt and btt trials running together, page-12

Blakes7,

The DT trial is randomised to 2:1.

You have interpreted the protocols different to what i did initially, I thought it was going to be 180 patients with ventrassist and 90 patients with alternative heart therapy. And 45 patients in Module B with a 2:1 being 23 odd patients with an alternative FDA approved device.

but in reading the protocols again i believe you may be correct. The DT trial states a total of 180 patients. Patients to be assigned in the ratio of 2:1 tothe different two groups i.e. one implanting with the ventrassist and the other the optimal heart therapy. So it would have to be 120 patients and 60 patients being a total of 180 in the group.

The same rationale for the Module B arm.

This is good news because it means that there only needs to be a total of 120 + 30 + say 120 remaining in BTT due to pooling of data with feasibilty = 270 patients.

At 20 centers initially (ramping up to 40 later) with implants at say one a month at each center , we could finish enrolment (theorectically) in say 8-9 months.

That is 20 x 1 per center per month x 4 months then at 40 centers x 1 per center per month = 8-9 months.
Complete enrolment Feb-March 2008. (6 months until end point and 6 months to submit data and wait for approval) Have approvals for BTT by feb 2009 and start selling in 2009 for BTT.

SOund conservative or wishfull thinking???

First things first START THE TRIALS!!!!! enough procrastination..