Clinical trial NCT05027685: The "Global Paradise System" Registry
Official title: The "Global Paradise® System" Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertension
Keywords: Hypertension
Blood pressure
Renal Denervation
Lead sponsor: ReCor Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-30
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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
* 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

Primary outcomes:
measure: Incidence of all-cause mortality
timeFrame: Through 5 Years post-procedure
measure: Incidence of new onset end-stage renal disease
timeFrame: Through 5 Years post-procedure
measure: Significant decline in renal function
timeFrame: Through 5 Years post-procedure
measure: New renal artery stenosis
timeFrame: Through 5 Years post-procedure
measure: Incidence of renal artery perforation or dissection requiring an invasive intervention
timeFrame: Through 5 Years post-procedure
measure: 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
timeFrame: Through 5 Years post-procedure
measure: Incidence of hospitalization for hypertensive crisis or symptomatic hypotension
timeFrame: Through 5 Years post-procedure
measure: Incidence of hospitalization for major cardiovascular- or hemodynamic-related events (e.g. HF; AF)
timeFrame: Through 5 Years post-procedure
measure: Incidence of new onset stroke, TIA or CVA
timeFrame: Through 5 Years post-procedure
measure: Incidence of acute myocardial infarction
timeFrame: Through 5 Years post-procedure
measure: Incidence of any coronary revascularization
timeFrame: Through 5 Years post-procedure
measure: Reduction in average home systolic/diastolic BP in mmHg as compared to enrollment
timeFrame: Through 5 Years post-procedure
measure: Reduction in average office systolic/diastolic BP in mmHg as compared to enrollment
timeFrame: Through 5 Years post-procedure
measure: Reduction in average ambulatory systolic/diastolic BP in mmHg (daytime, nighttime and 24-hr) as compared to enrollment
timeFrame: Through 5 Years post-procedure
measure: Incidence of home systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg
timeFrame: Through 5 Years post-procedure
measure: Incidence of office systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg
timeFrame: Through 5 Years post-procedure
measure: Incidence of ambulatory systolic BP (daytime/24-hr/night-time) reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg
timeFrame: Through 5 Years post-procedure
measure: Percentage of subjects who are controlled according to current guidelines
timeFrame: Through 5 Years post-procedure
measure: Change in office/home/ambulatory pulse pressure in mmHg
timeFrame: Through 5 Years post-procedure
measure: Change in office/home/ambulatory heart rate in bpm
timeFrame: Through 5 Years post-procedure
measure: Percentage of subjects without any anti-hypertensive treatment with analysis stratified by number of enrollment antihypertensive medications
timeFrame: Through 5 Years post-procedure
measure: Analysis of quarterly Home BP in mmHg
timeFrame: Through 5 Years post-procedure
measure: Change from enrollment in quality of life scores as measured by the 12-item Short Form Health Survey (SF-12)
timeFrame: Through 5 Years post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Ziekenhuis Aalst
city: Brussel
country: Belgium
facility: CHU Saint Pierre Brussels
city: Brussel
country: Belgium
facility: UCL St Luc
city: Bordeaux
country: France
facility: CHU Bordeaux Hôpital St. André
city: Paris
country: France
facility: HEGP (Hôpital Européen Georges Pompidouv) Paris
city: Pau
country: France
facility: Centre Hospitalier de Pau
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg Bad Krozingen
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin Campus Benjamin Franklin
city: Coburg
country: Germany
facility: Klinikum Coburg GmbH
city: Detmold
country: Germany
facility: Klinikum Lippe GmbH Detmold
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH Universitätsklinik
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Frankfurt
country: Germany
facility: Cardiovasculäres Centrum (CVC) Frankfurt
city: Hamm
country: Germany
facility: St. Barbara-Klinik Hamm Heessen
city: Homburg
country: Germany
facility: University Clinic of Saarland - Homburg
city: Köln
country: Germany
facility: Universitätsklinikum Köln
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Lübeck
country: Germany
facility: Sana Kliniken Lübeck gGmbH
city: Mainz
country: Germany
facility: Marienhaus Klinikum Mainz
city: München
country: Germany
facility: Detusches Herzzentrum München (DHM)
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus GmbH Stuttgart
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar Klinikum Villingen-Schwenningen
city: Monaco
country: Monaco
facility: Centre Hospitalier Princesse Grace Monaco
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
city: Rotterdam
country: Netherlands
facility: Erasmus MC Rotterdam
city: Geneva
country: Switzerland
facility: HUG Geneve Switzerland
city: Luzern
country: Switzerland
facility: Heart Center Lucerne -Luzerner Kantonsspital
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital, Bournemoth
city: Canterbury
country: United Kingdom
facility: Kent and Canterbury Hospital, Canterbury
city: Cardiff
country: United Kingdom
facility: University Hospital Wales, Cardiff
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth Hospital, Glasgow
city: London
country: United Kingdom
facility: Hammersmith Hospital (Imperial College Healthcare NHS Trust)
city: London
country: United Kingdom
facility: WHRC - Barts Health, London
city: Newcastle
country: United Kingdom
facility: Freeman Hospital, Newcastle
Study officials:
affiliation: Barts NIHR Biomedical Research Centre, William Harvey Research Institute, QMUL
name: Melvin Lobo, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: UKS Universitätsklinikum des Saarlandes, Kardiologie, Angiologie und internistische Intensivmedizin
name: Felix Mahfoud, Prof.
role: PRINCIPAL_INVESTIGATOR
References: