Twelve-month results of the Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot™ Ablation System (RAPID) study

Stefan Verheye, John Ormiston, Martin W. Bergmann, Horst Sievert, Arne Schwindt, Nikos Werner, Britta Vogel, Antonio Colombo

Research output: Contribution to journalArticle

Abstract

Aims: Renal denervation has emerged as a treatment option for patients with drug-resistant hypertension. This study was designed to assess the safety and effectiveness of the OneShot™ Renal Denervation System. Methods and results: RAPID is a prospective, multicentre, single-arm study which enrolled 50 patients at 11 clinical sites in Europe and New Zealand. Eligible patients had an office systolic blood pressure (SBP) ≥160 mmHg and were on a stable regimen of ≥3 antihypertensive medications including a diuretic. The primary safety endpoints were acute procedural safety at discharge and chronic procedural safety at six months. The primary effectiveness endpoint was the rate of office SBP reduction ≥10 mmHg at six months compared to baseline. While not a predefined endpoint, change in 24-hour ambulatory BP was evaluated. The mean baseline office SBP and diastolic BP measurements were 181.6±20.8 and 95.5±15.5 mmHg, respectively. Patients were on a mean of 5.1 antihypertensive medications at baseline. The mean office BP decreased by -20/-8 mmHg (p

Original languageEnglish
Pages (from-to)1221-1229
Number of pages9
JournalEuroIntervention
Volume10
Issue number10
DOIs
Publication statusPublished - Feb 1 2015

Keywords

  • Blood pressure
  • Radiofrequency ablation
  • Renal denervation
  • Resistant hypertension
  • Uncontrolled hypertension

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Verheye, S., Ormiston, J., Bergmann, M. W., Sievert, H., Schwindt, A., Werner, N., Vogel, B., & Colombo, A. (2015). Twelve-month results of the Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot™ Ablation System (RAPID) study. EuroIntervention, 10(10), 1221-1229. https://doi.org/10.4244/EIJY14M12-02