Medtronic SPYRAL HTN – OFF MED

Telephone Pre-screening Script

Global Clinical Study of Renal Denervation with the Symplicity Spyral™ multi-electrode renal denervation system in Patients with Uncontrolled Hypertension in the Absence of Antihypertensive Medications.

Date: ______Passed Telephone Screen: Yes / No

Patient Name: ______

Contact Number: ______

Comments: ______

Name of Person completing this interview: ______

Introduction:

“Hello. This is ______from the [Office of Dr. XX or University of XX].

I’m calling today to talk to you about your interest in participating in a high blood pressure research study. As part of prescreening for the study, we would like to ask you a few questions about your medical history to see if you would be eligible.Do you have 5 -10 minutes for me to tell you about the study and ask you some yes-or-no questions about your health?”

YesNo

If yes, continue.

If no, “Would you like me to call back at another time?”

  • If yes, “When would you like me to call back?”
  • If no, “Thank you for your time.”

“First, please confirm that I am speaking to (Subject’s Name)______.

Answering these questions is voluntary. And if any time during this prescreening you would like to stop and not participate or if you have any questions, just let me know.”

“At the end of these questions, if you are eligible and interested in participating in the clinical study, I will ask for more personal information. But if you do not qualify for the study or do not want to participate, we will not keep the information we collected today.”

“Would you like to continue now with the screening questions?”

------

Screening questions, if agreeable to telephone screen

[If patient does not know the answer to any question, proceed to the next.]

Are you between the ages of 20 and 80?

YesNo

If yes, “What is your date of birth?” ______and, continue.

If no, “Thank you for your time.”

“I am going to ask you some questions about your blood pressure medication.”

Are you currently taking any prescription medications for your high blood pressure?
YesNo

If no, continue.

If yes, “How many prescription medications are you currently taking for your high blood pressure?” ______

Name(s) of blood pressure medications:

Are you under a physician’s care? ______

Are you willing to go about 4 months without taking any blood pressure medications under a doctor’s supervision? ______

“Let me tell you a little bit about the requirements for participating. There are some medical conditions that would prevent you from participating in the study. May I ask you some yes-or-no questions about your health?”

YesNo

If no, “Thank you for your time.”

If yes, continue

Do you have Type 1 Diabetes? / Yes / No
Do you require supplemental oxygen during the day? (except for sleep apnea) / Yes / No
Do you have pulmonary hypertension? / Yes / No
Have you ever been told you have a tumor on your adrenal gland? / Yes / No
Do you have Cushing’s disease?
(The pituitary gland releases too much adrenocorticotropic hormone, ACTH) / Yes / No
Do you have untreated hyperthyroidism or primary hyperparathyroidism? / Yes / No
Do you use daily NSAID’s such as Aspirin, Motrin, Advil and/or Aleve? (Aspirin is allowed.) / Yes / No
What are your hours of work?
(If a patient gives a schedule that is night shift or if it varies between day and night, the patient would NOT qualify for the study.) / ______
Are you currently taking mineralocorticoid drugs (Aldosterone)? / Yes / No
Do you have any bleeding disorders? / Yes / No
Do you have an active peptic ulcer or upper GI bleeding within the past 6 months? / Yes / No
Have you had an organ transplant? / Yes / No
Do you have both of your kidneys? / Yes / No
Have you had a previous treatment of renal denervation? / Yes / No
“I am going to ask you a few more questions about your heart health.”
Do you have an allergy to Aspirin? / Yes / No
Has your doctor ever diagnosed you with unstable angina? / Yes / No
Have you fainted in the past three months? / Yes / No
Have you had a heart attack in the past three months? / Yes / No
Have you had a stroke in the past three months? / Yes / No
Do you have any other serious medical conditions? / Yes / No

If no to all the above questions, continue.

If yes to any of the above questions (or working night shift or the schedule varies), does NOT qualify. “Thank you for your time and interest in the study, but based on the answers you have provided, you do not qualify for this type of study.”

“A few more questions and we are almost finished.”

Do you have any upcoming or planned surgeries?

If no. continue.

If yes, [and in the opinion of the investigator, may affect study endpoints], would NOT qualify. “Thank you for your time and interest in the study, but based on the answers you have provided, you do not qualify for this type of study.”

Are you enrolled in another investigational drug or device trial?

If no, continue.

If yes, does not qualify (except if trial is long-term follow-up trial).
“Thank you for your time and interest in the study, but based on the answers you have provided, you do not qualify for this type of study.”

(If female) Are you pregnant, nursing, or planning to become pregnant?

If no, continue.

If yes, does NOT qualify.
“Thank you for your time and interest in the study, but based on the answers you have provided, you do not qualify for this type of study.”

If subject meets eligibility criteria, ask if he/she would like a brief explanation of the procedures of the study.

If Yes:

“The purpose of this clinical study is to provide additional information about a medical device intended to help treat high blood pressure in patients in the absence of medications for high blood pressure.

The procedure is called renal denervation, which is a procedure that may decrease the kidneys’ release of hormones that raise your blood pressure using a medical device catheter (thin tube) and generator combination. These catheters and generators are not commercially available in the United States and Japan and are considered investigational devices. However, they have been approved for commercial use in European countries and in Australia.

During a study procedure, the generator allows the catheter, which is inserted into your blood vessels, to deliver low-level radiofrequency (RF) energy through the wall of a blood vessel to the kidney (renal artery). This will disrupt nerve activity by either disabling or destroying the nerves that provide signals to the kidney and may in turn decrease high blood pressure.

This study will look at the safety and effectiveness of renal denervation using the device in lowering blood pressure.

If you enroll in the study, you will need to come in for several office visits. You also will be randomly assigned to one of two groups and you will not be told which group you are assigned to until your 12 months follow-up visit. One-half of the patients in the study will be treated with the device and one-half will NOT be treated with the device; then, the results of the two groups will be compared.

After all subjects have completed their12 months follow-up visit the subjects that did not get the procedure, may be offered renal denervation upon consultation with their physicians (If the treatment looks positive at that point in the trial).

It will take 3 years to complete this research study. During this time, we will ask you to make approximately 13 trial visits to our facility, depending on which group you are in.”

Invite them in for an initial visit to determine qualification for the trial:

“Based on your answers, we would like to invite you in for an initial screening visit where we can go over the study in more detail. We will further assess if you are eligible for the study. Would you like to come in for an initial screening visit?

Yes No

If no, “Again, thank you for your time.”

If yes, agree on time and date for appointment, then continue.

“Your first appointment may take up to two hours. We will review and sign the informed consent form together. Now I need your primary doctor’s name and your contact information.”

Name of your PCP
Home Address
Home Phone Number
Work / Cell Phone Number
Email address
“What is the best way to contact you?”

“Do you know where we are?”

“I can email or mail you directions.” (Provide verbal directions to the Doctor’s office or Hospital.)

“Do you have any questions?”

“Thank you so much for your time and interest. I will send you a copy of the consent form with more detailed information for you to review before our meeting. Please feel free to bring in questions you may have.”

“We will see you at the ______(Research Institute, Doctor’s office, or Hospital) on date______at time of appointment______.” (*Note: Only schedule morning appointments before 10:30 a.m.)

“We may call you the day before to remind you of the appointment.”

“Please contact me if you have any questions. My name is ______and I can be reached at ______.”

Thank you. [End call]

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