Survey | .:: Cardiokinetix ::.

Interventional PI*

Mobile*:

Office*:

Email*:

Heart Failure PI*

Mobile*:

Office*:

Email*:

Study Coordinator*

Mobile*:

Office*:

Email*:

Have the PI(s) had previous experience participating in cardiovascular device clinical trials (preferably include heart failure and structural heart device clinical trials)?

YES NO

If yes, indicate the most recent trials.

Trial

Number Enrolled

Number of Months Enrolling

Trial

Number Enrolled

Number of Months Enrolling

How many PMA/IDE clinical trials have the PI(s) participated in?

Research Center's Experience with Multi-Disciplinary Trials*

Competing Trials for Ischemic HF Patients*

What is your population catchment area that your HF clinical draws upon?*

How many heart failure patients are seen annually at your site?*

What percentage of those are ischemic?*

How many PCIs are performed annually by all operators at your site?*

Based on your understanding of the HF patient population that can be included in the trial (NYHA III – IV, EF between 15% -35%, and an akinetic or dyskinetic apex), how many patients do you think you will enroll per month?

Who will conduct the screening at your site (check all that apply)?

Will patient referrals come from institutions other than those covered under your IRBs review?

YES NO

Does the investigative site have SOPs pertaining to the acquisition of medical records for patient who might be hospitalized at another institution during participation in a clinical trial?

YES NO

Do you have an echo database that is searchable on clinical parameters (ie. key inclusion/exclusion criteria)?*

YES NO

What is the average lead time for CT imaging?*

What is your closure experience with a 14Fr or 16Fr access site?*

What resources do you believe would help you increase enrollment?*

What do you feel would be the most difficult aspect of finding patients who you could enroll in this trial?*

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Proposed Clinical Leadership