HypertensionEnligHTN IIINCT01836146
International First-in-Human Study of the EnligHTN Generation 2 System in Patients With Drug-resistant Uncontrolled Hypertension
A study testing EnligHTN™ Renal Artery Ablation Catheter in people with Hypertension and Renal Denervation, run by Abbott Medical Devices at 6 sites in 2 countries.
Trial summary
The purpose of this First-in-Human Clinical investigation is to evaluate the safety and performance of the St. Jude Medical EnligHTN™ Generation 2 Renal Denervation System for the treatment of patients with drug-resistant uncontrolled hypertension. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Renal Denervation
- What is being tested?
- EnligHTN™ Renal Artery Ablation Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Apr 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥ 18 and ≤ 80 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 Systolic Blood Pressure ≥ 160 mmHg at confirmatory visit
- Subject has a daytime mean Systolic Ambulatory Blood Pressure > 135 mmHg during the two week screening period
- Subject has an office Systolic Blood Pressure that remains ≥160 mmHg despite the stable use of ≥3 antihypertensive medications concurrently at maximally tolerated doses, of which one is a diuretic or subject was previously on diuretic but documented to be diuretic intolerant, for a minimum of 14 days prior to the procedure and with an expectation to maintain for a minimum of 180 days post procedure.
Who cannot join
- Subject has significant renovascular abnormalities such as renal artery stenosis > 30% in either renal artery
- Subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts
- Subject has hemodynamically significant valvular heart disease as determined by the Study Investigator
- Subject has a life expectancy less than 12 months, as determined by a Study Investigator
- Subject is participating in another clinical study which has the potential to impact their hypertension management (pharmaceutical/device/homeopathic)
- Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
Show all 16Show fewer
- Subject has active systemic infection
- Subject has renal arteries with diameter(s) < 4 mm in diameter or <20 mm in length
- Subject has an estimated Glomerular Filtrate Rate (eGFR) <45 mL/min per 1.73 m2 using the Modified Diet in Renal Disease (MDRD) formula
- Subject has Diabetes Mellitus Type I
- Subject has multiple main renal arteries in either kidney
- Subject has an identified secondary cause of hypertension (for example, including, but not limited to, Polycystic kidney disease, Cushing's syndrome, Aldosteronism)
- Subject has evidence of significant abdominal aortic aneurysm (defined as maximum diameter of >4 cm)
- Subject has had a myocardial infarction, unstable angina pectoris or cerebrovascular accident less than 180 days prior to enrollment
- Subject is expected to have cardiovascular intervention within the next 180 days
- Subject has a condition which would interfere with the accurate interpretation of the study objectives including but not limited to a large arm diameter that is unable to accommodate the blood pressure cuff or arrhythmia that interferes with automatic pulse sensing.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Australia4 sites
St Andrews Hospital
Adelaide, South Australia
St. Vincent's Hospital Melbourne
Fizroy, Victoria
Monash Heart/Southern Health
Melbourne, Victoria
Royal Melbourne Hospital
Melbourne, Victoria
New Zealand2 sites
Auckland City Hospital
Auckland, 1023
Dunedin Hospital
Dunedin, 9016
About this study
The purpose of this First-in-Human Clinical investigation is to evaluate the safety and performance of the St. Jude Medical EnligHTN™ Generation 2 Renal Denervation System for the treatment of patients with drug-resistant uncontrolled hypertension.
- Conditions
- Hypertension, Renal Denervation
- Being tested
- EnligHTN™ Renal Artery Ablation Catheter
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnligHTN™ Renal Artery Ablation CatheterDevice
| Study group | Role | What they receive |
|---|---|---|
| Renal Artery Ablation | Experimental | Not described Receives: Device: EnligHTN™ Renal Artery Ablation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Objective
To characterize the rate of serious procedural and device related adverse events from date of procedure through 6 months post procedure, as adjudicated by the Clinical Events Committee (CEC).
Measured: 6 months
Performance objective
To characterize the reduction of office Systolic Blood Pressure at 6 months post procedure as compared to baseline.
Measured: 6 months
Secondary outcomes (3)
Change in Ambulatory Blood Pressure
Characterization of the change in Ambulatory Blood Pressure parameters over time as compared to baseline
Measured: 1 month, 3 month, 6 month, 12 month, 18 month, 2 years
New renal artery stenosis or aneurysm at the site of ablation
Characterization of renovascular safety as measured by new renal artery stenosis or aneurysm at the site of ablation over time as compared to baseline
Measured: 1 month, 3 month, 6 month, 12 month, 18 month, 2 years
Renal Function Change
Characterization of renal function change over time as compared to baseline as measured by changes in: eGFR, serum creatinine and cystatin C
Measured: 1 month, 3 month, 6 month, 12 month, 18 month, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionMar 2014
- Study completionSep 2015
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.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836146
- Sponsor's protocol ID
- 1202
- Acronym
- EnligHTN III
- Status last verified
- Feb 2019
- First submitted
- 16 Apr 2013
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International First-in-Human Study of the EnligHTN Generation 2 System in Patients With Drug-resistant Uncontrolled Hypertension
- ClinicalTrials.gov ID
- NCT01836146
- Acronym / sponsor ID
- EnligHTN III / 1202
- Conditions
- Hypertension, Renal Denervation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 19 Apr 2013 (estimated)
- 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 purpose of this First-in-Human Clinical investigation is to evaluate the safety and performance of the St. Jude Medical EnligHTN™ Generation 2 Renal Denervation System for the treatment of patients with drug-resistant uncontrolled hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal Artery Ablation | Experimental | Device: EnligHTN™ Renal Artery Ablation Catheter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is ≥ 18 and ≤ 80 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 Systolic Blood Pressure ≥ 160 mmHg at confirmatory visit
- Subject has a daytime mean Systolic Ambulatory Blood Pressure > 135 mmHg during the two week screening period
Key exclusion criteria (16 listed)
- Subject has significant renovascular abnormalities such as renal artery stenosis > 30% in either renal artery
- Subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts
- Subject has hemodynamically significant valvular heart disease as determined by the Study Investigator
- Subject has a life expectancy less than 12 months, as determined by a Study Investigator
- Subject is participating in another clinical study which has the potential to impact their hypertension management (pharmaceutical/device/homeopathic)
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 |
|---|---|---|
| EnligHTN™ Renal Artery Ablation Catheter | Device | Renal Artery Ablation |
Primary outcome
Safety Objective
Time frame: 6 months
To characterize the rate of serious procedural and device related adverse events from date of procedure through 6 months post procedure, as adjudicated by the Clinical Events Committee (CEC).
Performance objective
Time frame: 6 months
To characterize the reduction of office Systolic Blood Pressure at 6 months post procedure as compared to baseline.
3 secondary outcomes
Change in Ambulatory Blood Pressure
Time frame: 1 month, 3 month, 6 month, 12 month, 18 month, 2 years
New renal artery stenosis or aneurysm at the site of ablation
Time frame: 1 month, 3 month, 6 month, 12 month, 18 month, 2 years
Renal Function Change
Time frame: 1 month, 3 month, 6 month, 12 month, 18 month, 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EnligHTN™ Renal Artery Ablation Catheter in people with Hypertension and Renal Denervation, run by Abbott Medical Devices at 6 sites in 2 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 6 inclusion and 16 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: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, New Zealand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Objective (time frame: 6 months). The study lists 2 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 Feb 2019.