Registry documenting long-term safety and effectiveness of renal denervation for hypertension

Global SYMPLICITY Registry (GSR) Denervation Findings in Real World (DEFINE)

This study is trying to see how safe and effective renal denervation is for people with high blood pressure over the long term.

Quick facts

• Study type: Observational
• Enrollment: 5000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Medtronic Vascular (Industry-sponsored)
• Locations: 2 sites (Homburg, Saarlandes and 1 other locations)
• Trial ID: NCT01534299 on ClinicalTrials.gov

What this trial studies

This is a prospective, multi-center, single-arm, non-interventional registry aimed at documenting the long-term safety and effectiveness of renal denervation in patients with hypertension. Approximately 5000 patients will be enrolled from over 300 sites worldwide, with follow-up ranging from 1 to 5 years post-procedure. Data collected will include blood pressure measurements, medication changes, and clinical data related to hypertension. The registry will help expand the knowledge base regarding the Medtronic renal denervation system in a real-world patient population.

Who should consider this trial

Good fit: Ideal candidates for this registry are adults aged 18 and older with uncontrolled hypertension who are suitable for renal denervation.

Not a fit: Patients with controlled hypertension or those not eligible for renal denervation may not benefit from this registry.

Why it matters

Potential benefit: If successful, this registry could provide valuable insights into the long-term management of hypertension through renal denervation.

How similar studies have performed: Other studies on renal denervation have shown promise, suggesting that this approach may be effective in managing hypertension.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years or minimum age as required by local regulations
* The patient is an acceptable candidate for renal denervation based upon the Instructions For Use for the Medtronic renal denervation system. The procedure must be performed with an initial use, market-released Medtronic renal denervation catheter.
* The patient or legal representative has been informed of the nature of the registry has consented to participate and authorized the collection and release of this medical information by signing a consent form ("Patient Informed Consent Form" or "Patient Data Release Authorization Form")

Where this trial is running

Homburg, Saarlandes and 1 other locations

• Universitätsklinikum des Saarlandes — Homburg, Saarlandes, Germany (Recruiting)
• Universitätsspital Basel — Basel, Switzerland, Switzerland (Recruiting)

Study contacts

• Principal investigator: Michael Böhm, Prof. — University Hospital, Saarland
• Study coordinator: K. Wandrey

Conditions Hypertension