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Status unknownNCT01888315Updated Jun 27, 2013

Influence of Catheter-based Renal Denervation in Diseases With Increased Sympathetic Activity

A Phase 1/2 interventional study of Renal denervation with Symplicity Flex Medtronic/Ardian and Renal denervation with EnligHTN St. Jude Medical in Hypertension, Heart Failure and Chronic Kidney Disease, sponsored by University Hospital, Saarland. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-27.

Sponsored by University Hospital, Saarland · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
1,000
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The study is aiming to document the long-term safety and effectiveness of renal denervation in patients with hypertension and other diseases characterized by elevated sympathetic drive. Catheter-based renal denervation will be performed using CE marked, percutaneous, systems.

Read the detailed description

Inclusion Criteria

  1. Individual is 18 years of age.
  2. Individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry.
  3. Patient scheduled for renal sympathetic denervation using market-released device.

Exclusion Criteria

  1. In the eyes of the treating physician, the renal artery anatomy would interfere with safe cannulation of the renal artery or meets local standards for surgical repair.
  2. Individual has any serious medical condition, which in the opinion of the treating physician may adversely affect the safety and/or effectiveness of the participant (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, significant anemia, etc.).
02

Conditions studied

  • Hypertension
  • Heart Failure
  • Chronic Kidney Disease
  • Diabetes
  • Heart Rhythm Disorders

Keywords

  • Hypertension
  • Heart Failure
  • Sympathetic activity
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

University Hospital, Saarland is the lead sponsor of 41 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Individual is 18 years of age.
  2. Individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry.
  3. Patient scheduled for renal sympathetic denervation using market-released device.

Exclusion criteria

Exclusion Criteria

  1. In the eyes of the treating physician, the renal artery anatomy would interfere with safe cannulation of the renal artery or meets local standards for surgical repair.
  2. Individual has any serious medical condition, which in the opinion of the treating physician may adversely affect the safety and/or effectiveness of the participant (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, significant anemia, etc.).
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • Experimental
    Catheter-based renal denervation

    One procedure will be performed using one of the CE-marked devices for renal denervation: Device: Renal denervation with Symplicity Flex Medtronic/Ardian Device: Renal denervation with EnligHTN St. Jude Medical Device: Renal denervation with Paradise Recor Device: Renal denervation with V2 Vessix

    Device: Renal denervation with Symplicity Flex Medtronic/Ardian · Device: Renal denervation with EnligHTN St. Jude Medical · Device: Renal denervation with Paradise Recor · Device: Renal denervation with V2 Vessix

  • No intervention
    Medical therapy

    Best medical therapy using guideline recommended drugs in each disease state.

Interventions

  • DeviceRenal denervation with Symplicity Flex Medtronic/Ardian

    Renal denervation using CE-marked devices will be performed according to best medical practice.

  • DeviceRenal denervation with EnligHTN St. Jude Medical

    Renal denervation using CE-marked devices will be performed according to best medical practice.

  • DeviceRenal denervation with Paradise Recor

    Renal denervation using CE-marked devices will be performed according to best medical practice.

  • DeviceRenal denervation with V2 Vessix

    Renal denervation using CE-marked devices will be performed according to best medical practice.

06

What researchers measure

Primary outcomes

  1. Safety and efficacy of renal denervation

    Effect on blood pressure including office, ABPM, and home-based measurements. Number of adverse events (death, stroke, myocardial infarction, new dialysis, and congestive heart failure). Changes of antihypertensive medications. Effects on renal function assessed with glomerular filtration rate. Renovascular safety (renal artery stenosis) assessed by duplex ultrasound.

    Time frame: Baseline to 6 months

Secondary outcomes

  1. Effect of renal denervation on different organ systems.

    Myocardial function and geometry using echo and MRI. Heart rate changes and arrhythmias. Glucose metabolism and insulin resistance (fasting and during oGTT). Hospitalization rates (eg. hypertensive emergencies, heart failure, etc).

    Time frame: Baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months

  2. Safety and efficacy of renal denervation

    Effect on blood pressure including office, ABPM, and home-based measurements. Number of adverse events (death, stroke, myocardial infarction, new dialysis, and congestive heart failure). Changes of antihypertensive medications. Effects on renal function assessed with glomerular filtration rate. Renovascular safety (renal artery stenosis) assessed by duplex ultrasound.

    Time frame: Baseline, 3, 12, 18, 24, 30, 36, 42, 48, 54, 60 months

07

Study locations

1 of 1 sites recruiting
  • University Hospital Saarland
    Homburg/Saar, 66421, Germany
    • Michael Böhm, MD · Contact
    • Felix Mahfoud, MD · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01888315
Lead sponsor
University Hospital, Saarland
Responsible party
Sponsor
First posted
Jun 27, 2013
Start date
Jan 2011
Primary completion
Jan 2021 (estimated)
Completion
Jan 2021 (estimated)
Last update
Jun 27, 2013

Study contacts

Felix Mahfoud, MD
Contact
felix.mahfoud@uks.eu
+4968411621346
Michael Böhm, MD
Contact
michael.boehm@uks.eu
+4968411623372
Felix Mahfoud, MD
study director · University Hospital, Saarland
Michael Böhm, MD
principal investigator · University Hospital, Saarland

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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