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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01888315
Other study ID # Symplicity Extension
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received September 4, 2012
Last updated June 24, 2013
Start date January 2011
Est. completion date January 2021

Study information

Verified date June 2013
Source University Hospital, Saarland
Contact Felix Mahfoud, MD
Phone +4968411621346
Email felix.mahfoud@uks.eu
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.


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.).


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date January 2021
Est. primary completion date January 2021
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Device:
Renal denervation with Symplicity Flex Medtronic/Ardian
Renal denervation using CE-marked devices will be performed according to best medical practice.
Renal denervation with EnligHTN St. Jude Medical
Renal denervation using CE-marked devices will be performed according to best medical practice.
Renal denervation with Paradise Recor
Renal denervation using CE-marked devices will be performed according to best medical practice.
Renal denervation with V2 Vessix
Renal denervation using CE-marked devices will be performed according to best medical practice.

Locations

Country Name City State
Germany University Hospital Saarland Homburg/Saar

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Saarland

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Baseline to 6 months Yes
Secondary 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).
Baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months Yes
Secondary 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.
Baseline, 3, 12, 18, 24, 30, 36, 42, 48, 54, 60 months Yes
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