Observational Study of the EnligHTN Renal Denervation System in Europe

October 14, 2019 updated by: Abbott Medical Devices

EnligHTN European Observational Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Hainaut
      • Lodelinsart, Hainaut, Belgium, 6042
        • Hôpital Civil Marie Curie
  • Estonia
    • Harjuma
      • Tallinn, Harjuma, Estonia, 13419
        • North Estonia Medical Centre
  • Italy
    • Lombardia
      • Alzano Lombardo, Lombardia, Italy, 24068
        • Dr. Gianluigi Patelli
    • Lombardy
      • Milano, Lombardy, Italy, 20131
        • Instituto Clinico Citta Studi
      • Osio Sotto, Lombardy, Italy, 24040
        • Policlinico San Marco
    • Peimonte
      • Novara, Peimonte, Italy, 28100
        • Clinica San Gaudenzio
  • Portugal
    • Lisbon
      • Carnaxide, Lisbon, Portugal, 2795-523
        • Hospital de Santa Cruz
  • Spain
      • Badajoz, Spain, 06010
        • Hopspital Infanta Cristina
      • Valencia, Spain, 46206
        • Hospital Universitari i Politecnic La Fe
      • Vigo, Spain, 36204
        • Hospital Xeral-Cies de Vigo
    • Andalucia
      • Huelva, Andalucia, Spain, 21005
        • Hospital Juan Ramón Jiménez
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universitaria de Navarra
  • United Kingdom
    • Nirelnd
      • Portadown, Nirelnd, United Kingdom, BT63 5QQ
        • Craigavon Area Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with uncontrolled hypertension

Description

Inclusion Criteria:

  • Subject is planned to undergo a renal denervation procedure for the treatment of hypertension
  • Subject is ≥18 years of age at time of consent
  • Subject must be able and willing to provide written informed consent
  • Subject must be able and willing to comply with the required follow-up schedule
  • Subject has office SBP ≥ 140 mmHg
  • Subject has established hypertension (diagnosed ≥12 months prior to baseline) and is on a guideline based drug regimen at a stable (≥ 14 days) and a fully tolerated dose consisting of ≥3 anti-hypertensive medications (including 1 diuretic)

Exclusion Criteria:

  • Subject has known significant renovascular abnormalities such as renal artery stenosis > 30%
  • Subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts
  • Subject has a history of hemodynamically significant valvular heart disease
  • Subject has blood clotting abnormalities
  • Subject life expectancy is < 12 months, as determined by the Study Investigator
  • Subject is participating in another clinical study which has the potential to impact his/her hypertension management (pharmaceutical/ device/ homeopathic)
  • Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
  • Subject has active systemic infection
  • Subject has known renal arteries with diameter(s) < 4 mm
  • Subject has an estimated GFR <45 mL/min per 1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula
  • Subject had a renal transplant or is awaiting a renal transplant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Uncontrolled hypertension patients
The study will enroll 500 patients planned to undergo a renal denervation procedure (with the 'EnligHTN™ Renal Denervation System') for the treatment of their uncontrolled hypertension.
Device: EnligHTN™ Renal Denervation System
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Mean Change in Office Systolic Blood Pressure at 6 Months
Time Frame: Baseline and 6 months
Baseline and 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of Peri-procedural Adverse Events up Until 30 Days Post Procedure
Time Frame: 30 days
30 days
Mean Change in Office Systolic Blood Pressure at 1 Month
Time Frame: Baseline and 1 month
Baseline and 1 month
Mean Change in Office Diastolic Blood Pressure at 1 Month
Time Frame: Baseline and 1 month
Baseline and 1 month
Mean Change in Ambulatory Systolic Blood Pressure at 1 Month
Time Frame: Baseline and 1 month
Baseline and 1 month
Mean Change in Ambulatory Diastolic Blood Pressure at 1 Month
Time Frame: Baseline and 1 month
Baseline and 1 month
Percentage of Subjects Achieving Office Systolic Blood Pressure < 140 mmHg at 1 Month
Time Frame: 1 month
1 month
Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 6 Months
Time Frame: Baseline and 6 months
Baseline and 6 months
Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 12 Months
Time Frame: Baseline and 12 months
Baseline and 12 months
Renovascular Safety at 6 Months (Renal Artery Stenosis)
Time Frame: 6 months
Assessment of renovascular safety as measured by new renal artery stenosis or aneurysm at the site of ablation.
6 months
Mean Change in Office Systolic Blood Pressure at 12 Months
Time Frame: Baseline and 12 months
Baseline and 12 months
Mean Change in Office Diastolic Blood Pressure at 6 Months
Time Frame: Baseline and 6 months
Baseline and 6 months
Mean Change in Office Diastolic Blood Pressure at 12 Months
Time Frame: Baseline and 12 months
Baseline and 12 months
Mean Change in Ambulatory Systolic Blood Pressure at 6 Months
Time Frame: Baseline and 6 months
Baseline and 6 months
Mean Change in Ambulatory Systolic Blood Pressure at 12 Months
Time Frame: Baseline and 12 months
Baseline and 12 months
Mean Change in Ambulatory Diastolic Blood Pressure at 6 Months
Time Frame: Baseline and 6 months
Baseline and 6 months
Mean Change in Ambulatory Diastolic Blood Pressure at 12 Months
Time Frame: Baseline and 12 months
Baseline and 12 months
Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 6 Months
Time Frame: 6 months
6 months
Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 12 Months
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: José Diaz, MD, Hospital Juan Ramon Jimenez, Huelva, Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CV-12-064-EU-HT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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