The purpose of this observational study is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of participants with uncontrolled hypertension in clinical routine practice.
The EnligHTN European Observational study is designed to collect more data, critical to the benefit of the therapy, within a clinical routine setting.
Study Type
OBSERVATIONAL
Enrollment
68
The EnligHTN™ Renal Denervation System is designed to deliver radiofrequency (RF) energy to the renal nerves to achieve targeted denervation. The system consists of the EnligHTN™ RF Ablation Generator (generator), the EnligHTN™ Renal Artery Ablation Catheter (ablation catheter), and the EnligHTN™ Guiding Catheter (optional).
Hôpital Civil Marie Curie
Lodelinsart, Hainaut, Belgium
North Estonia Medical Centre
Tallinn, Harjuma, Estonia
Dr. Gianluigi Patelli
Alzano Lombardo, Lombardy, Italy
Mean Change in Office Systolic Blood Pressure at 6 Months
Time frame: Baseline and 6 months
Assessment of Peri-procedural Adverse Events up Until 30 Days Post Procedure
Time frame: 30 days
Mean Change in Office Systolic Blood Pressure at 1 Month
Time frame: Baseline and 1 month
Mean Change in Office Diastolic Blood Pressure at 1 Month
Time frame: Baseline and 1 month
Mean Change in Ambulatory Systolic Blood Pressure at 1 Month
Time frame: Baseline and 1 month
Mean Change in Ambulatory Diastolic Blood Pressure at 1 Month
Time frame: Baseline and 1 month
Percentage of Subjects Achieving Office Systolic Blood Pressure < 140 mmHg at 1 Month
Time frame: 1 month
Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 6 Months
Time frame: Baseline and 6 months
Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 12 Months
Time frame: Baseline and 12 months
Renovascular Safety at 6 Months (Renal Artery Stenosis)
Assessment of renovascular safety as measured by new renal artery stenosis or aneurysm at the site of ablation.
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Instituto Clinico Citta Studi
Milan, Lombardy, Italy
Policlinico San Marco
Osio Sotto, Lombardy, Italy
Clinica San Gaudenzio
Novara, Peimonte, Italy
Hospital de Santa Cruz
Carnaxide, Lisbon District, Portugal
Hospital Juan Ramon Jimenez
Huelva, Andalusia, Spain
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain
Hopspital Infanta Cristina
Badajoz, Spain
...and 3 more locations
Mean Change in Office Systolic Blood Pressure at 12 Months
Time frame: Baseline and 12 months
Mean Change in Office Diastolic Blood Pressure at 6 Months
Time frame: Baseline and 6 months
Mean Change in Office Diastolic Blood Pressure at 12 Months
Time frame: Baseline and 12 months
Mean Change in Ambulatory Systolic Blood Pressure at 6 Months
Time frame: Baseline and 6 months
Mean Change in Ambulatory Systolic Blood Pressure at 12 Months
Time frame: Baseline and 12 months
Mean Change in Ambulatory Diastolic Blood Pressure at 6 Months
Time frame: Baseline and 6 months
Mean Change in Ambulatory Diastolic Blood Pressure at 12 Months
Time frame: Baseline and 12 months
Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 6 Months
Time frame: 6 months
Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 12 Months
Time frame: 12 months