Interventional Cardiovascular Research and Clinical Trials

History

1. How long has your site been conducting clinical trials?

2. Please list all cardiovascular studies in which you have participated over the last 12 months.

Coronary

Endovascular

Structural Heart

TAVR/TAVI Specific

3. Do you have a heart team approach at your institution? (check all that apply)

Interventional cardiologist

Cardiothoracic surgeon

Echo cardiographer/Imaging specialist

Neurologist

4. Do you have a hybrid procedure room in the Cath lab, operating room, or both?

1
 Interventional Cardiovascular Research and Clinical Trials

TAVR/TAVI Assessment

5. For how many years has TAVR/TAVI been performed at your site?

>1 year

>3 years

>5 years

6. What is the surgical risk of the patients who receive TAVR/TAVI according to STS score:

These percentages should add up to 100%.

Inoperable (%)

High Risk (%)

Moderate (%)

Low (%)

7. What is the average number of TAVR/TAVI procedures at your site?

Per week

Per month

Per year

8. What is the percentage of your TAVR/TAVI patients:

Referred from external
sources (%)?

Referred from inside your

institution (%)?

2
9. What % of TAVR/TAVI patients:
Go home within 2 days or
less

Go home within 5 days

Get readmitted to your

institution?

Get readmitted to another

institution?

10. List the percentages for routes of access for TAVR/TAVI procedures at your site:

Transfemoral (%)

Transaortic (%)

Transapical (%)

Subclavian access (%)

Other (%)

11. What % of your non-research TAVR/TAVI patients with aortic stenosis suffers from severe renal
insufficiency (eGFR calculated with the MDRD formula) or is on dialysis?

12. What % of your TAVR/TAVI patients had an indication for oral anti-coagulation therapy, prior to
TAVR/TAVI?

13. What % of TAVR/TAVI patients present with new-onset AF within one week after TAVR/TAVI?

14. What is your post-TAVR/TAVI mortality data in the last year?

In-hospital (%)

At 1 year (%)

3
15. Please indicate the post TAVR/TAVI antiplatelet therapy regimen (single or dual).

Drug #1:

Dose:

Treatment Duration
(months):

Drug #2:

Dose:

Treatment Duration
(months):

Drug #3:

Dose:

Treatment Duration
(months):

16. In patients who underwent TAVR/TAVI, would you agree to a treatment of either: (pick one)

Three months of anti-Xa inhibitor plus aspirin followed by anti-Xa inhibitor monotherapy for max twenty-one months verus?

Three months of DAPT (aspirin + clopidogrel) followed by aspirin monotherapy for max twenty-one months?

17. Is in-hospital neurologic evaluation performed by a stroke neurologist as standard of care?

Yes

No

If not a stroke neurologist, who?

18. Do you perform a follow-up TEE for all subjects as standard of care?

Yes

No

If yes, when?

4
19. Do you perform a follow-up TTE for all subjects as standard of care?

Yes

No

If yes, when?

5
 Interventional Cardiovascular Research and Clinical Trials

Study/Trial Experience and History of TAVR Trials

20. In how many multicenter TAVR-Randomized Clinical Trials (RCT) has your site participated during the
past 5 years?

Number:

Please list trials:

21. Is your center currently or will it soon be enrolling in any other trials of TAVR/TAVI?

If yes, list study name, PI, description, and anticipated enrollment completion date for each study in the
space provided for each trial.

Yes or no

Trial #1

Trial #2

Trial #3

Specify how you manage

competing studies with
similar inclusion/exclusion
criteria.

22. Do you or your institution hold a valid GCP certificate?

Yes

No

Please specify

6
23. Are you familiar with local regulatory requirements?

Yes

No

24. Do you agree to obtain written informed consent prior to patient enrollment in a study?

Yes

No

25. Could you briefly explain the screening and consenting procedure at your site?

26. What has been your Lost-to Follow-up rate in trials with:

2 year follow-ups?

3 year follow-ups?

5 year follow-ups?

27. Do you have a designated Research Study Coordinator/Nurse?

Yes or no

If yes, what is the

experience level (years) of
this designated Research
Study Coordinator/Nurse?

If no, how many Research

Coordinators work in your
team?

28. Does your site have experience with an EDC (Electronic Data Capture) System?

Yes

No

7
29. Does your site use electronic medical records?

Yes

No

If yes, please provide system name

30. Can trial CRA’s/Monitors access your institutions EMR for those study subjects?

Yes

No

31. Check all that your site permits:

On-site monitoring

Auditing

Site inspection

32. Does your site provide internet access for the study personnel during monitoring visits?

Yes

No

33. Are you willing to comply with Sponsor requirements for archiving study records following the
completion of the study?

Yes

No

8
 Interventional Cardiovascular Research and Clinical Trials

Laboratory

34. Does the laboratory have sufficient resources (time and staff) to perform the study related analyses
within the required time?

Yes

No

35. Is your laboratory accredited?

Yes

No

If yes, by whom?

36. Is test equipment calibrated and maintained according to a plan?

Yes

No

Please specify

37. Does your laboratory require specific financial arrangements with the study sponsor?

Yes

No

If yes, please specify

9
 Interventional Cardiovascular Research and Clinical Trials

Study Drug/Pharmacy

38. Does your institution have a dedicated research pharmacy? Check all that apply

Clinical research

Coordinating pharmacy

Other

39. Who is responsible for receipt, distribution, and destruction of study drugs?

40. Are your storage conditions for study drugs adequate? (Rate 1-5, where 5 is perfectly adequate and
1 is unsuitable)

Humidity (1-5)

Access by study personnel

(1-5)

Temperature (1-5)

41. Do you have written procedures specifying the receipt and dispensing of investigational products?

Yes

No

Provide any details you wish

10
42. Do you have written procedures for destruction of study drugs?

Yes

No

Provide any details you wish

43. Is your site willing to destroy study drugs using your own SOP or do you prefer the study sponsor’s
procedure?

44. Are there written procedures ensuring study drug availability during hours when the pharmacy is
closed?

Yes

No

45. Do you have a fee schedule that you can make available for pharmacy charges?

Yes

No

11
 Interventional Cardiovascular Research and Clinical Trials

International Review Board Processes

46. How often does your IRB meet?

47. What is the estimated turnaround time in weeks to obtain IRB approval?

1-3 weeks

4-6 weeks

>6 weeks

48. Are there any other committees at your site that need to approve clinical trials?

Yes

No

If yes, specify the committee(s)

49. How far in advance does the submission package need to be submitted to your IRB?

50. Please indicate your IRB fees:

Initial IRB review

Annual reviews

Protocol revisions

Other

12
51. Do you use an internal IRB or a contract “outside” IRB?

Internal

Contract

If contract IRB, please name:

52. Does your IRB dictate free study medication for control arm in open-label post-approval clinical
studies?

Yes

No

53. Does your site and/or IRB have specific policies regarding acceptable means to find lost/missing
patients?

Yes

No

54. Are there any restrictions/limitations to using patient locator services and accessing patient information
from public records?

Yes

No

If yes, please specify

55. Is a fully executed contract with the study sponsor required before your IRB can provide IRB approval?

Yes

No

13
56. Do any study documents need to be translated and validated into a non-English language for IRB
submission?

Yes or no

If yes, specify document(s)

required.

Which languages are

common at your
institution?

57. Has your site been audited by:

The FDA?

If yes, have you received

any warning letters, such
as FDA 483?

Any other regulatory

agency?

58. Are any physicians at your institution on the FDA Debarment List?

Yes

No

If yes, please explain

14
 Interventional Cardiovascular Research and Clinical Trials

Study Contract

59. What is the turnaround time for a site contract to be finalized with the study sponsor or CRO?

>3 weeks

>6 weeks

Other (please specify)

60. Will your hospital accept:

A Sponsor contract template?

Or only the hospital template?

61. Please provide the name(s) of:

The person(s) who signs

investigator agreements

The person(s) who signs

financial agreements

15
 Interventional Cardiovascular Research and Clinical Trials

Overall Feasibility Aspects

62. Are there challenges to implementing research studies at your facility (i.e. resources, study design, or
current standard of care)?

Yes

No

If yes, please specify

63. Other comments that you would like to share with us or useful information for us to consider.

16