Pivotal Study News
THRIVE
July 2025 Issue
Study Performance Snapshot:
Cumulative Patient Enrollment
6% (15 / 262)
Site Activity
5 randomizing
7 consenting
2 pre-screening
16 none
Highlights
Welcome to the first issue of the THRIVE Pivotal Study newsletter! Each issue will bring you the latest updates on study performance, important reminders and everything you need to stay informed and engaged in THRIVE.
As of this issue’s release, we’re excited to report 30 activated sites (20 in the US and 10 in Europe), and 15 patients randomized. We are also celebrating Boston Scientific's acquisition of SoniVie Ltd. (you can read the full announcement here), a significant step forward for our mission and the future of TIVUS™.
We hope you enjoy this newsletter and find it valuable. Thank you for your hard work, dedication, and the excellence you bring to this study. We’re thrilled to have you as part of the THRIVE journey!
Top 5 Sites
Consents
Randomized
NC Heart
Dr. Zidar | Raleigh | North Carolina
22
10
Arkansas Heart
Dr. Paixao | Little Rock | Arkansas
08
02
SIU School of Medicine
07
01
Dr. Flack | Springfield | Illinois
Sana Kliniken
Dr. Weil | Lubeck | Germany
05
01
Renown
Dr. Flack | Reno | Nevada
02
01
Site Spotlight
Photo: First THRIVE treatment. January 31, 2025. North Carolina Heart & Vascular
North Carolina Heart & Vascular
Leading the Way in THRIVE Enrollment
This first issue, we’re proud to shine the spotlight on North Carolina Heart & Vascular and PI, Dr. Zidar, for their outstanding performance and commitment to the THRIVE study. Since conducting their first procedure on January 31, the team at NC Heart has demonstrated exceptional efficiency and dedication.
As of this newsletter’s release, they’ve successfully consented 22 patients and randomized 10, setting a remarkable example for all participating sites. Their ability to promptly schedule patients for informed consent signing and screening has played a key role in their success.
We extend our heartfelt thanks to the entire NC Heart team for their tireless efforts and continued excellence.
Keep up the great work!
Reminders
At screening visit after consent has been obtained, patient must meet systolic and diastolic office blood pressure requirements to be eligible for the study.
Please send your Screening & Enrollment log to your site manager every week.
Please remember to enter ICF details and data into the EDC within 5 business days of visit.
Important THRIVE Contacts
Erin M. Spinner, PhD
Vice President, Global Clinical SHV, RDN and ICTx Operations,
Boston Scientific
Patient Recruitment Support
PinPoint
What is PinPoint?
PinPoint is THRIVE's own Patient Recruitment Project, aimed at helping create and maintain a healthy pipeline of candidates for our participating sites. PinPoint combines our geofencing social media campaign, our external team of screeners and Monday.com, our CRM (Customer Relationship Management) software, all working together to facilitate candidates to your site.
PinPoint Reminders for Active Sites:
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Log-in daily to Monday.com.
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Check for new candidates to contact.
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Contact new candidates within 48 hours to avoid loosing their interest.
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Attempt to contact at least 3 times before archiving candidates.
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Consider using text messages and email if candidates are not answering the phone.
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Update patient status for each attempted contact.
Do you need support with Monday.com?
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For support in Europe and Israel, please contact Omri Gill: omri@sonivie.com; +972-54-483-6492
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For support in the US, please contact Carlos Lander: carlos@sonivie.com; +1-754-317-4007
Video Content
Prof. Michael Jonas explains how TIVUS™ by SoniVie can Advance Hypertension Treatment
Educational Animated Video demonstrates how TIVUS™ by SoniVie works
Useful Links
SoniVie Website:
Boston Scientific Website:
Systems Access & Support
ABPM, Office and Home Blood Pressure Monitors
Access to Platform:
CRM / Database of Candidates from Social Media Campaigns
Access to Platform:
EDC / Electronic Data Capture Software
Access to Platform:
Medical Imaging Anonymization and Workflow
Access to Platform:
Urine Samples Management and Storage Under ISO 9001 Regime
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Will SoniVie/Boston Scientific be using a central laboratory?All imaging and BP measurements to go through a central core lab. Sites will utilize their local labs for blood and urine samples with the exception of the urine concentration for antihypertensive medications which will go to the central lab: BioRep.
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Will SoniVie/Boston Scientific be needing access to site's EMR in order for the screeners to contact potential patients?Neither SoniVie/Boston Scientific nor the screeners will need access to MCVI’s EMR. At the SIV we will be providing thorough training on the full process.
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How are the patients screened?The social media campaign will include advertisements through social media sites such as Facebook and Instagram. Patients will be directed to a landing page to answer basic questions. Those who qualify based on those answers will be pushed through to a screener who will review the inclusion/exclusion criteria with them directly.
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What PHI protections are in place for this process?Only the screener (consultant and not an employee of SoniVie/Boston Scientific) will see the patient’s PHI. If the screener confirms that the patient is an ideal candidate, they will then provide them to the site closest to the patient. We, as the sponsor, will never have access or visibility to the patient questionnaires.
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What are all the timepoints and escape criteria that patients can crossover?Patients are offered the chance to crossover if they remain uncontrolled at 6M follow-up once unblinded. The escape criteria can occur at any timepoint according to their office BP readings.
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Does one person at the site need to be blinded and the other unblinded?Yes, one blinded and one unblinded study coordinator. The unblinded coordinator would be needed at the procedure and would be expected to complete data entry for the procedure in order to maintain the blind for other site staff. Additional details will be provided at the SIV.
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What website will be used for the campaign?The website is a SoniVie/Boston Scientific built as part of our recruitment recruitment project branded as "PinPoint" for this study. The CRM (Customer Relationship Management) platform used to manage candidates coming from PinPoint is Monday.com. Training to cover these tools will be provided during or after SIV.
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Is the titration between 1-2 months based on the Home BP?Patients should remain off meds between 1-2 months post procedure. If the patient meets escape criteria they should be put back on AHTN medication according to the medication escalation protocol in the study protocol.
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At what temperature do the urine concentration samples need to be stored?-20, preferably -80.
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Will subject compensation be paid by site or a third-party vendor (e.g.: Greenphire)?We do not have a third-party vendor for patient compensation. There is a line item in the budget for it.
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Will the 2:1 (treatment to sham) stratification will be balanced at each site?Yes. The protocol states that randomization will be generated by computer and stratified by center using blocks of small size and treatment permutation. The 2:1 (treatment to sham) stratification will be balanced at each site.
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In case of hypothyroidism, if corrected, would the patient be eligible?Yes, the patient would be eligible.
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What is the definition of rapid AFIB criteria?Uncontrolled and symptomatic.
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Are we required to put patients back on medication after two months?Only if uncontrolled, please refer to medication protocol escalation.
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If patient becomes pregnant during the study do we withdraw them?We would defer to ethics committee.
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During washout what happens if a subject needs to take medication? What is our plan to ensure that patients are being honest?Urine will be collected at end of study to check the adherence of the patient.
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Are we going to be treating only main artery? Or artery and accessories?Both can be treated if vessel diameter is >4mm. Review protocol angiographic criteria for complete information.
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If previously treated for PAD, can catheter go through a stent?No.
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Do the patient study visits need to be done before 10am?Not required, but recommended (for on-med portion of the study).
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What about the BlueTooth, would they bring in their phone? What about people that do not have BlueTooth phone/music?We will provide noise cancelling headphones. Patients can use their own devices or, if not allowed, a hospital device (based on individual hospital requirements).
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What if patient has a known intolerance to an ARB?Medications to be modified at physician's discretion and with approval from sponsor.
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Is there treatment failure?We are not collecting treatment failure. An analysis may be done at the end of the trial to identify non-responders.
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How to manage subjects who are taking GLP-1s?The steering committee says that while these drugs do influence blood pressure, they believe that GLP-1s are not exclusionary. We monitor medications throughout the study and can track their relationship with blood pressure. Also, because the study is randomized, GLP-1 use should appear in both study groups.
Thank You
Thank you for reading the first issue of the THRIVE newsletter. We hope you found the content helpful and inspiring as we continue moving forward together in this important study. Your dedication and collaboration are what make the THRIVE study possible, and we are incredibly grateful to have you as part of this effort.
Until next time—let’s keep THRIVING!
Feedback?
If you have any feedback, questions, or ideas for future editions, don’t hesitate to reach out to Carlos Lander:
carlos@sonivie.com
+1-754-317-4007