HypertensionGPSRegistryNCT05027685
The "Global Paradise System" Registry
An observational study of Hypertension, run by ReCor Medical, Inc. at 55 sites in 9 countries.
Trial summary
The GPS Registry is a multi-centre, single-arm, non-interventional (observational) registry. In addition to collecting data from patients treated as per standard clinical practice, the Registry will also regularly collect telemetric Home Blood Pressure (HBP) measurements and Patient Reported Outcome (PRO) data via a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- The Paradise Ultrasound Renal Denervation System
- Type of treatment
- Medical device
- How many people
- 3,000 participants
- Where
- 55 sitesin 9 countries
- Study dates
- 13 Jan 2022to 31 Dec 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The GPS Registry will collect both retrospective and prospective data in patients treated as per the sites normal practice with the commercially available Paradise Ultrasound Renal Denervation System.
Who may be able to join
- Appropriately signed and dated informed consent
- Age ≥18 at time of consent
- Patient candidate for renal denervation with the Paradise System based on physician's assessment OR Patient treated with the Paradise Ultrasound Renal Denervation System within the 6 months prior to consent
Who cannot join
- Patients who meet any of the contraindications listed in the Instructions for Use will be excluded.
- The contraindications are:
- Stented renal artery
- Less than 18 years of age
- Pregnant
- Known allergy to contrast medium
Show all 11Show fewer
- Renal arteries diameter < 3 mm and > 8 mm
- Renal artery with Fibromuscular (FMD) disease
- Renal artery aneurysm
- Renal artery stenosis of any origin >30%
- Iliac/femoral artery stenosis precluding insertion of the Paradise catheter
Trial locations and contacts
55 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
55 sites in 9 countries
Germany24 sites, 20 recruiting
- Suspended
Krankenhaus Maria Hilf Bad Neuenahr-Ahrweiler
Ahrweiler, 53474
- Recruiting
Universitäts-Herzzentrum Freiburg Bad Krozingen
Bad Krozingen
Olga Greb
Jochen Strübin
- Recruiting
Charité Universitätsmedizin Berlin Campus Benjamin Franklin
Berlin
Thomas Haese, Dr., thomas.haese@dhzc-charite.de
Georg Girke, Dr.
- Terminated
Klinikum Coburg GmbH
Coburg
- Recruiting
Universitätsklinikum Köln
Cologne
Ana Heinrichs
Marcel Halbach, Prof. Dr.
- Recruiting
Klinikum Lippe GmbH Detmold
Detmold
Angelika Göckeler
Marion Denart
- Recruiting
Herzzentrum Dresden GmbH Universitätsklinik
Dresden
Monika Famulla
Robert Höllriegel, Dr.
- Recruiting
Städt. Klinikum Dresden (Standort Friedrichstadt)
Dresden
Kerstin Spranger, Kerstin.Spranger@klinikum-dresden.de
Frank R. Heinzel, Prof.
- Recruiting
Universitätsklinikum Düsseldorf
Düsseldorf
Claudia Schmid, Dr.
Johannes Stegbauer, Prof. Dr.
- Recruiting
Universitätsklinikum Erlangen
Erlangen
Ulrike Heinritz
Roland Schmieder, Prof. Dr.
- Withdrawn
Cardiovasculäres Centrum (CVC) Frankfurt
Frankfurt
- Recruiting
Universitätsklinikum Halle (Saale), AöR
Halle, 06120
Alexander Vogt, Dr.
- Active, not recruiting
St. Barbara-Klinik Hamm Heessen
Hamm
- Recruiting
Universitätsklinikum der Ruhr-Universität Bochum, Medizinische Klinik II
Herne, 44625
Kerstin Voitz, "erstin.voitz@elisabethgruppe.de
Esra Sari, esra.sari@elisabethgruppe.de
- Recruiting
University Clinic of Saarland - Homburg
Homburg, D-66421
Christina Koch
Michael Böhm, Prof. Dr.
- Recruiting
Herzzentrum Leipzig GmbH
Leipzig, D-04289
Ina Wagner
Karl Fengler, Dr.
- Recruiting
Sana Kliniken Lübeck GmbH
Lübeck
Tanja Köllner
Luise Blödorn
- Recruiting
Universitätsmedizin der Johannes Gutenberg Universität Mainz
Mainz, 55131
Philipp Lurz, Prof Dr Dr
- Recruiting
Marienhaus Klinikum Mainz
Mainz
Bärbel Kasesberger
Silvio Kittlaß
- Not yet recruiting
Internistisches Klinikum München Süd GmbH, Klinik für Kardiologie und internistische Intensivmedizin
München, 83179
Louise Guston, studienzentrale@ikms.de
Lukas Gleirscher, Dr.
- Recruiting
Detusches Herzzentrum München (DHM)
München
Renate Bratke
Michael Joner, Prof. Dr.
- Not yet recruiting
Marienhaus Klinikum Bendorf - Neuwied - Waldbreitbach
Neuwied
Margit Over, margit.over@marienhaus.de
Burkhard Hügel, Dr.
- Recruiting
Robert-Bosch-Krankenhaus GmbH Stuttgart
Stuttgart
Sarah Fröbel, Dr.
Steffen Endres, Dr.
- Recruiting
Schwarzwald-Baar Klinikum Villingen-Schwenningen
Villingen-Schwenningen
Oxana Ruff
Mirjam Lehrer
United Kingdom11 sites
- Active, not recruiting
Royal Bournemouth Hospital, Bournemoth
Bournemouth
- Active, not recruiting
Kent and Canterbury Hospital, Canterbury
Canterbury
- Active, not recruiting
University Hospital Wales, Cardiff
Cardiff
- Active, not recruiting
Russells Hall Hospital
Dudley
- Active, not recruiting
Queen Elizabeth Hospital, Glasgow
Glasgow
- Active, not recruiting
Castle Hill Hospital Hull
Hull
- Active, not recruiting
Hammersmith Hospital (Imperial College Healthcare NHS Trust)
London
- Active, not recruiting
Royal Brompton Hospital
London
- Active, not recruiting
St Thomas' Hospital
London
- Active, not recruiting
WHRC - Barts Health, London
London
- Suspended
Freeman Hospital, Newcastle
Newcastle
France5 sites, 1 recruiting
- Active, not recruiting
CHU Bordeaux Hôpital St. André
Bordeaux
- Active, not recruiting
CHU Grenoble Alpes - Hôpital Michallon
Grenoble, La Tronche, 38700
- Withdrawn
Assistance Publique Hôpitaux de Marseille (AP-HM)
Marseille, 13354
- Recruiting
HEGP (Hôpital Européen Georges Pompidouv) Paris
Paris
V. Paquet
C. Déan
- Active, not recruiting
Centre Hospitalier de Pau
Pau
Belgium4 sites
- Active, not recruiting
OLV Ziekenhuis Aalst
Aalst
- Active, not recruiting
CHU Saint Pierre Brussels
Brussels
- Active, not recruiting
UCL St Luc
Brussels
- Active, not recruiting
Clinique CHS MontLégia
Liège, 4000
Netherlands3 sites, 1 recruiting
- Suspended
Noordwest Ziekenhuisgroep
Alkmaar
- Withdrawn
Maastricht University Medical Center
Maastricht, 6229
- Recruiting
Erasmus MC Rotterdam
Rotterdam
V. Zeijen
Jost Daemen, Dr.
Switzerland3 sites, 3 recruiting
- Recruiting
Universitätsspital Basel
Basel, 4031
Lucas Lauder, Dr.
Felix Mahfoud, Prof. Dr.
- Recruiting
HUG Geneve Switzerland
Geneva
Laetitia Gallego
Sylviane Bottone
- Recruiting
Heart Center Lucerne -Luzerner Kantonsspital
Lucerne
Brigitta Mehmann
Stefan Toggweiler, Prof. Dr.
Austria2 sites, 1 recruiting
- Suspended
Medical University of Vienna,
Vienna, 1090
- Recruiting
Klinikum Wels-Grieskirchen GmbH
Wels, 4600
Thomas Weber, Dr.
Spain2 sites
- Terminated
Hospital Universitario German Trias i Pujol
Barcelona, 08916
- Terminated
Hospital Clinico Universitario S.Carlos
Madrid, 28040
Monaco1 site
- Active, not recruiting
Centre Hospitalier Princesse Grace Monaco
Monaco
About this study
Official title: The "Global Paradise® System" Registry
The GPS Registry is a multi-centre, single-arm, non-interventional (observational) registry. In addition to collecting data from patients treated as per standard clinical practice, the Registry will also regularly collect telemetric Home Blood Pressure (HBP) measurements and Patient Reported Outcome (PRO) data via a standardized quality of life questionnaire. The objective of the GPS Registry is to document the long-term safety and effectiveness of the commercially available Paradise Ultrasound Renal Denervation System when used per its labelling in patients deemed to be candidates for RDN as per physician's assessment.
Read the detailed description
Renal denervation (RDN) by way of ultrasound is is a catheter-based technique to deliver ultrasound energy to thermally ablate and disrupt the renal efferent and afferent sympathetic nerves while sparing the renal arterial wall. The ReCor Medical ParadiseTM Ultrasound Renal Denervation System (ParadiseTM System) is a product admitted for clinical use implementing this technique. The goal of ultrasound renal denervation (ultrasound RDN) is to achieve a reduction in sympathetic over-activity with the resultant effect of reducing systemic arterial blood pressure (BP), and mitigating resultant end organ damage. With the expected increase in the number of patients to be treated in clinical practice with ultrasound RDN, and the importance of collecting real-world data on the long-term use and performance of ultrasound RDN through the use of the ParadiseTM System in a large population of patients, the Global ParadiseTM System (GPS) Registry has been set-up
- Conditions
- Hypertension
- Being tested
- The Paradise Ultrasound Renal Denervation System
- Keywords
- Hypertension, Blood pressure, Renal Denervation
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Paradise Ultrasound Renal Denervation SystemDevice
The CE-marked and commercially available ReCor Medical Paradise Ultrasound Renal Denervation System (Paradise System) is a catheter-based device designed to use ultrasound energy to thermally ablate the nerves surrounding the renal artery and serving the kidney.
| Study group | Role | What they receive |
|---|---|---|
| Renal Denervation Treatment | Patients candidate for treatment or already treated within 6 months prior to consent, as per the sites normal practice with the commercially available Paradise Ultrasound Renal Denervation System, will be enrolled in this single arm registry. Receives: Device: The Paradise Ultrasound Renal Denervation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of all-cause mortality
Rate of mortality attributed to any causality as per site standard practice.
Measured: Through 5 Years post-procedure
Incidence of new onset end-stage renal disease
eGFR<15 mL/min/m2 or need for renal replacement therapy as per site standard practice
Measured: Through 5 Years post-procedure
Significant decline in renal function
≥50% increase in serum creatinine (mg/dL)
Measured: Through 5 Years post-procedure
New renal artery stenosis
>70% confirmed by CTA/MRA as per site standard practice.
Measured: Through 5 Years post-procedure
Incidence of renal artery perforation or dissection requiring an invasive intervention
Rate of renal artery perforation or dissection attributed to any causality as per site standard practice.
Measured: Through 5 Years post-procedure
Incidence of major vascular complications (e.g, clinically significant groin hematoma, arteriovenous fistula, pseudoaneurysm) requiring surgical repair, interventional procedure, thrombin injection, or blood transfusion as per site standard practice
Rate of renal major vascular complications attributed to any causality as per site standard practice.
Measured: Through 5 Years post-procedure
Incidence of hospitalization for hypertensive crisis or symptomatic hypotension
Hospitalization for hypertensive crisis or symptomatic hypotension as per site standard practice.
Measured: Through 5 Years post-procedure
Incidence of hospitalization for major cardiovascular- or hemodynamic-related events (e.g. HF; AF)
Hospitalization for major cardiovascular- or hemodynamic-related events as per site standard practice.
Measured: Through 5 Years post-procedure
Incidence of new onset stroke, TIA or CVA
Incidence of new onset stroke, TIA or CVA as per site standard practice.
Measured: Through 5 Years post-procedure
Incidence of acute myocardial infarction
Incidence of acute myocardial infarction as per site standard practice.
Measured: Through 5 Years post-procedure
Incidence of any coronary revascularization
Rate of any coronary revascularization as per site standard practice.
Measured: Through 5 Years post-procedure
Reduction in average home systolic/diastolic BP in mmHg as compared to enrollment
Rate of reduction in average home systolic/diastolic BP in mmHg as compared to enrollment as per site standard practice.
Measured: Through 5 Years post-procedure
Reduction in average office systolic/diastolic BP in mmHg as compared to enrollment
Rate of reduction in average office systolic/diastolic BP in mmHg as compared to enrollment as per site standard practice.
Measured: Through 5 Years post-procedure
Reduction in average ambulatory systolic/diastolic BP in mmHg (daytime, nighttime and 24-hr) as compared to enrollment
Rate of reduction in average ambulatory systolic/diastolic BP in mmHg (daytime, nighttime and 24-hr) as compared to enrollment as per site standard practice.
Measured: Through 5 Years post-procedure
Incidence of home systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg
Rate of incidence of home systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg as per site standard practice.
Measured: Through 5 Years post-procedure
Incidence of office systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg
Rate of incidence of office systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg as per site standard practice.
Measured: Through 5 Years post-procedure
Incidence of ambulatory systolic BP (daytime/24-hr/night-time) reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg
Rate of incidence of ambulatory systolic BP (daytime/24-hr/night-time) reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg as per site standard practice.
Measured: Through 5 Years post-procedure
Percentage of subjects who are controlled according to current guidelines
Percentage of subjects who are controlled according to current guidelines as per site standard practice.
Measured: Through 5 Years post-procedure
Change in office/home/ambulatory pulse pressure in mmHg
Rate change in office/home/ambulatory pulse pressure in mmHg as per site standard practice.
Measured: Through 5 Years post-procedure
Change in office/home/ambulatory heart rate in bpm
Change in office/home/ambulatory heart rate in bpm as per site standard practice.
Measured: Through 5 Years post-procedure
Percentage of subjects without any anti-hypertensive treatment with analysis stratified by number of enrollment antihypertensive medications
Rate percentage of subjects without any anti-hypertensive treatment with analysis stratified by number of enrollment antihypertensive medications per site standard practice.
Measured: Through 5 Years post-procedure
Analysis of quarterly Home BP in mmHg
Analysis of quarterly Home BP in mmHg as per site standard practice.
Measured: Through 5 Years post-procedure
Change from enrollment in quality of life scores as measured by the 12-item Short Form Health Survey (SF-12)
The 12-item Short Form Health Survey (SF-12) is a measure of health-related quality-of-life. Scores for each domain range from 0 to 100, with a higher score indicating a more favorable health state.
Measured: Through 5 Years post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start13 Jan 2022
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- ReCor Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sofie Brouwers, Prof., Principal investigator, OLV Ziekenhuis Aalst BelgiumFelix Mahfoud, Prof., Principal investigator, Klinik für Kardiologie, Universitäres Herzzentrum Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027685
- Sponsor's protocol ID
- CLN-0927
- Acronym
- GPSRegistry
- Status last verified
- Jun 2026
- First submitted
- 26 Jul 2021
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The "Global Paradise® System" Registry
- ClinicalTrials.gov ID
- NCT05027685
- Acronym / sponsor ID
- GPSRegistry / CLN-0927
- Conditions
- Hypertension
- Keywords
- Hypertension, Blood pressure, Renal Denervation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- ReCor Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The GPS Registry is a multi-centre, single-arm, non-interventional (observational) registry. In addition to collecting data from patients treated as per standard clinical practice, the Registry will also regularly collect telemetric Home Blood Pressure (HBP) measurements and Patient Reported Outcome (PRO) data via a standardized quality of life questionnaire. The objective of the GPS Registry is to document the long-term safety and effectiveness of the commercially available Paradise Ultrasound Renal Denervation System when used per its labelling in patients deemed to be candidates for RDN as per physician's assessment.
Detailed description
Renal denervation (RDN) by way of ultrasound is is a catheter-based technique to deliver ultrasound energy to thermally ablate and disrupt the renal efferent and afferent sympathetic nerves while sparing the renal arterial wall. The ReCor Medical ParadiseTM Ultrasound Renal Denervation System (ParadiseTM System) is a product admitted for clinical use implementing this technique. The goal of ultrasound renal denervation (ultrasound RDN) is to achieve a reduction in sympathetic over-activity with the resultant effect of reducing systemic arterial blood pressure (BP), and mitigating resultant end organ damage. With the expected increase in the number of patients to be treated in clinical practice with ultrasound RDN, and the importance of collecting real-world data on the long-term use and performance of ultrasound RDN through the use of the ParadiseTM System in a large population of patients, the Global ParadiseTM System (GPS) Registry has been set-up
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal Denervation Treatment | – | Device: The Paradise Ultrasound Renal Denervation SystemPatients candidate for treatment or already treated within 6 months prior to consent, as per the sites normal practice with the commercially available Paradise Ultrasound Renal Denervation System, will be enrolled in this single arm registry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The GPS Registry will collect both retrospective and prospective data in patients treated as per the sites normal practice with the commercially available Paradise Ultrasound Renal Denervation System.
Key inclusion criteria (3 listed)
- Appropriately signed and dated informed consent
- Age ≥18 at time of consent
- Patient candidate for renal denervation with the Paradise System based on physician's assessment OR Patient treated with the Paradise Ultrasound Renal Denervation System within the 6 months prior to consent
Key exclusion criteria (11 listed)
- Patients who meet any of the contraindications listed in the Instructions for Use will be excluded.
- Stented renal artery
- Less than 18 years of age
- Pregnant
- Known allergy to contrast medium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Paradise Ultrasound Renal Denervation SystemThe CE-marked and commercially available ReCor Medical Paradise Ultrasound Renal Denervation System (Paradise System) is a catheter-based device designed to use ultrasound energy to thermally ablate the nerves surrounding the renal artery and serving the kidney. | Device | Renal Denervation Treatment |
Primary outcome
Incidence of all-cause mortality
Time frame: Through 5 Years post-procedure
Rate of mortality attributed to any causality as per site standard practice.
Incidence of new onset end-stage renal disease
Time frame: Through 5 Years post-procedure
eGFR<15 mL/min/m2 or need for renal replacement therapy as per site standard practice
Significant decline in renal function
Time frame: Through 5 Years post-procedure
≥50% increase in serum creatinine (mg/dL)
New renal artery stenosis
Time frame: Through 5 Years post-procedure
>70% confirmed by CTA/MRA as per site standard practice.
Incidence of renal artery perforation or dissection requiring an invasive intervention
Time frame: Through 5 Years post-procedure
Rate of renal artery perforation or dissection attributed to any causality as per site standard practice.
Incidence of major vascular complications (e.g, clinically significant groin hematoma, arteriovenous fistula, pseudoaneurysm) requiring surgical repair, interventional procedure, thrombin injection, or blood transfusion as per site standard practice
Time frame: Through 5 Years post-procedure
Rate of renal major vascular complications attributed to any causality as per site standard practice.
Incidence of hospitalization for hypertensive crisis or symptomatic hypotension
Time frame: Through 5 Years post-procedure
Hospitalization for hypertensive crisis or symptomatic hypotension as per site standard practice.
Incidence of hospitalization for major cardiovascular- or hemodynamic-related events (e.g. HF; AF)
Time frame: Through 5 Years post-procedure
Hospitalization for major cardiovascular- or hemodynamic-related events as per site standard practice.
Incidence of new onset stroke, TIA or CVA
Time frame: Through 5 Years post-procedure
Incidence of new onset stroke, TIA or CVA as per site standard practice.
Incidence of acute myocardial infarction
Time frame: Through 5 Years post-procedure
Incidence of acute myocardial infarction as per site standard practice.
Incidence of any coronary revascularization
Time frame: Through 5 Years post-procedure
Rate of any coronary revascularization as per site standard practice.
Reduction in average home systolic/diastolic BP in mmHg as compared to enrollment
Time frame: Through 5 Years post-procedure
Rate of reduction in average home systolic/diastolic BP in mmHg as compared to enrollment as per site standard practice.
Reduction in average office systolic/diastolic BP in mmHg as compared to enrollment
Time frame: Through 5 Years post-procedure
Rate of reduction in average office systolic/diastolic BP in mmHg as compared to enrollment as per site standard practice.
Reduction in average ambulatory systolic/diastolic BP in mmHg (daytime, nighttime and 24-hr) as compared to enrollment
Time frame: Through 5 Years post-procedure
Rate of reduction in average ambulatory systolic/diastolic BP in mmHg (daytime, nighttime and 24-hr) as compared to enrollment as per site standard practice.
Incidence of home systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg
Time frame: Through 5 Years post-procedure
Rate of incidence of home systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg as per site standard practice.
Incidence of office systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg
Time frame: Through 5 Years post-procedure
Rate of incidence of office systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg as per site standard practice.
Incidence of ambulatory systolic BP (daytime/24-hr/night-time) reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg
Time frame: Through 5 Years post-procedure
Rate of incidence of ambulatory systolic BP (daytime/24-hr/night-time) reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg as per site standard practice.
Percentage of subjects who are controlled according to current guidelines
Time frame: Through 5 Years post-procedure
Percentage of subjects who are controlled according to current guidelines as per site standard practice.
Change in office/home/ambulatory pulse pressure in mmHg
Time frame: Through 5 Years post-procedure
Rate change in office/home/ambulatory pulse pressure in mmHg as per site standard practice.
Change in office/home/ambulatory heart rate in bpm
Time frame: Through 5 Years post-procedure
Change in office/home/ambulatory heart rate in bpm as per site standard practice.
Percentage of subjects without any anti-hypertensive treatment with analysis stratified by number of enrollment antihypertensive medications
Time frame: Through 5 Years post-procedure
Rate percentage of subjects without any anti-hypertensive treatment with analysis stratified by number of enrollment antihypertensive medications per site standard practice.
Analysis of quarterly Home BP in mmHg
Time frame: Through 5 Years post-procedure
Analysis of quarterly Home BP in mmHg as per site standard practice.
Change from enrollment in quality of life scores as measured by the 12-item Short Form Health Survey (SF-12)
Time frame: Through 5 Years post-procedure
The 12-item Short Form Health Survey (SF-12) is a measure of health-related quality-of-life. Scores for each domain range from 0 to 100, with a higher score indicating a more favorable health state.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sofie Brouwers, Prof. principal investigator
OLV Ziekenhuis Aalst Belgium
Felix Mahfoud, Prof. principal investigator
Klinik für Kardiologie, Universitäres Herzzentrum Basel, Switzerland
55 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by ReCor Medical, Inc. at 55 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in Germany, United Kingdom, France, Belgium, Netherlands and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helen Reeve-Stoffer, PhD (+44 (0) 794 774 8006, hreeve-stoffer@recormedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of all-cause mortality (time frame: Through 5 Years post-procedure). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.