An interventional study of Renal Denervation (Symplicity® Renal Denervation System) in Uncontrolled Hypertension, sponsored by Medtronic Vascular. Completed at 20 sites in 10 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-05-20.
Sponsored by Medtronic Vascular (part of Medtronic) · Not applicable, Interventional, and Treatment
An international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension.
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's enrollment of 106 is above the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →Medtronic Vascular is the lead sponsor of 60 studies on the registry; 7 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
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Exclusion Criteria:
Renal Denervation and maintenance of anti-hypertensive medications
Device: Renal Denervation (Symplicity® Renal Denervation System)
Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
Catheter-based renal denervation
Office Systolic Blood Pressure Reduction
The primary effectiveness endpoint is change in Office Systolic Blood Pressure (SBP) from baseline to 6 months post-randomization.
Time frame: Baseline to 6 months
190 patients screened as eligible for study inclusion between June 9, 2009 and January 15, 2010.
| Milestone | Renal Denervation | Control |
|---|---|---|
| Started | 52 | 54 |
| Completed | 49 | 51 |
| Not completed | 3 | 3 |
| Withdrew: Withdrawal by subject | 1 | 2 |
| Withdrew: Missed visit | 2 | 1 |
The primary effectiveness endpoint is change in Office Systolic Blood Pressure (SBP) from baseline to 6 months post-randomization.
| mmHg | Renal Denervation | Control |
|---|---|---|
| Office Systolic Blood Pressure Reduction | -31.7 ± 23.1 | 0.9 ± 20.6 |
Collected over 12 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1. DENERVATION | — | 5/52 (9.6%) | 18/52 (34.6%) |
| 2. CONTROL | — | 4/54 (7.4%) | 7/54 (13%) |
| Event | 1. DENERVATION | 2. CONTROL |
|---|---|---|
| Hypertensive CrisisVascular disorders | 2/52 | 0/54 |
| VertigoEar and labyrinth disorders | 1/52 | 0/54 |
| NauseaGastrointestinal disorders | 1/52 | 0/54 |
| VomitingGastrointestinal disorders | 1/52 | 0/54 |
| AstheniaGeneral disorders | 1/52 | 0/54 |
| OedemaGeneral disorders | 1/52 | 0/54 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/52 | 0/54 |
| DysarthriaNervous system disorders | 1/52 | 0/54 |
| HypertensionVascular disorders | 1/52 | 1/54 |
| HypotensionVascular disorders | 1/52 | 0/54 |
| Event | 1. DENERVATION | 2. CONTROL |
|---|---|---|
| Back PainMusculoskeletal and connective tissue disorders | 5/52 | 0/54 |
| DizzinessNervous system disorders | 4/52 | 0/54 |
| Hypertensive CrisisVascular disorders | 0/52 | 4/54 |
| BradycardiaCardiac disorders | 3/52 | 0/54 |
| Oedema PeripheralGeneral disorders | 3/52 | 0/54 |
| HypotensionVascular disorders | 3/52 | 0/54 |
| HeadacheNervous system disorders | 0/52 | 3/54 |
| Age, Continuous(years) | Renal Denervation | Control | Total |
|---|---|---|---|
| Mean | 58.2 ± 11.9 | 58.3 ± 12.3 | 58.2 ± 12.0 |
| Sex: Female, Male(Participants) | Renal Denervation | Control | Total |
|---|---|---|---|
| Female | 18 | 27 | 45 |
| Male | 34 | 27 | 61 |
| Region of Enrollment(participants) | Renal Denervation | Control | Total |
|---|---|---|---|
| France | 1 | 3 | 4 |
| Poland | 1 | 1 | 2 |
| Belgium | 4 | 2 | 6 |
| Spain | 2 | 2 | 4 |
| Australia | 5 | 5 | 10 |
| Austria | 1 | 2 | 3 |
| Latvia | 3 | 4 | 7 |
| Germany | 32 | 29 | 61 |
| Switzerland | 0 | 1 | 1 |
| United Kingdom | 3 | 5 | 8 |
The record gives a start of Jun 2009, a primary completion of Sep 2010 and a completion of May 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Feb 2014, 3 years 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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