SPYRAL HTN Global Clinical Trial Program

The program purpose is to provide information about the safety and effectiveness of an investigational procedure to help reduce blood pressure in patients whose blood pressure is uncontrolled.

CAUTION: Investigational device. Limited by U.S. law to investigational use.

SPYRAL HTN-ON MED Pilot Study

Results with medications

This study evaluated the effect of the Symplicity™ blood pressure procedure in the presence of anti-hypertensive drugs.
 
Three-year follow-up
  • 18.7 mmHg reduction in 24-hour systolic ambulatory blood pressure (ABPM) for RDN patients versus baseline (p<0.01)2
  • 20.9 mmHg reduction in office systolic blood pressure2
  • >80% of patients taking meds achieved SBP <140 mmHg with the Symplicity procedure2
  • Zero device or procedural safety events2

Design details

  • Estimated enrollment: 340 participants
  • Study type: interventional (clinical trial)
  • Allocation: randomized
  • Intervention model: parallel assignment
  • Masking: single (participant)
  • Primary purpose: treatment
  • Actual study start date: July 2015
See the full design manuscript

More details are available at clinicaltrials.gov.

Safety results at 3 years.

Adverse event (number of events) RDN
(n = 38)		 Sham control
(n = 42)
All-cause death 0 1||
New myocardial infarction 0 0
New stroke 1 0
Hospitalization for hypertensive crisis / emergency 1 0
Sign. embolic event resulting in end-organ damage 0 0
Vascular complications 0 0
Major bleeding 0 0
Renal function    
New renal artery stenosis > 70% 0 0
Renal artery reintervention 0 0
Serum creatinine elevation >50% 0 0
New onset end stage renal disease 0 0
Table data2
|| One cardiovascular death occurred 693 days post-procedure. Patient was found unconscious at home; cause of death unknown.
¶ One patient had hypertension crisis and stroke at 427 days post-procedure. Patient presented to emergency department with weakness on left side and elevated BP 193/123 mmHg, received in-patient treatment, and was discharged in stable condition.

HTN-OFF MED trial design

Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications (SPYRAL PIVOTAL - SPYRAL HTN-OFF MED trial)

Trial data

The SPYRAL HTN-OFF MED pivotal trial met its secondary efficacy endpoint, showing clinically significant blood pressure reductions at three months.3† The powered efficacy endpoints for the trial were:

  • Change in 24-hour systolic blood pressure (SBP) at three months
  • Change in office SBP at three months

Zero major adverse events‡ through three months in the RDN treatment arm.3

Patients enrolled in the SPYRAL HTN-OFF MED study were absent of their anti-hypertension medication. After the primary endpoint, medications were started/reintroduced by following a titration protocol.

Download the pivotal trial data
Results from people who recieved the Symplicity procedure in the HTN-OFF MED Pivotal trial.

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Results from people who recieved the Symplicity procedure in the HTN-OFF MED Pivotal trial.

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Design details

  • Estimated Enrollment: 331 patients
  • Study Type: Interventional (Clinical Trial)
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Treatment
  • Actual Study Start Date: June 2015
See the full design manuscript

More details are available at clinicaltrials.gov.

Safety results at 3 months

n (%) RDN
(n = 165)		 Sham Control
(n = 165)
New myocardial infarction 0 0
New stroke 0 1 (0.6%)
Major Adverse Events 1 (0.6%) 0
  Death 0 0
  New onset end stage renal disease 0 0
  Sign. embolic event resulting in end-organ damage 0 0
  Renal artery perforation or dissection requiring intervention 0 0
  Vascular complications 0 0
  Hospitalization for hypertensive crisis/emergency 1 (0.6%) 0
Major bleeding (TIMI) 0 0
Serum creatinine elevation > 50% 0 0

Table Data2

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CAUTION.  Investigational device. Limited by U.S. law to investigational use.

*

In typical uncontrolled hypertension patients.

†

An analysis of covariance model was used adjusting for baseline blood pressure.

‡

Death, stroke, end-stage renal disease, or MI.

§

ANCOVA Adjusted; secondary efficacy analysis

1

Kandzari DE, Böhm M, Mahfoud F, et al. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. The Lancet. 2018;391:2346–2355.

2

Mahfoud F, Kandzari DE, Kario K, et al. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial. The Lancet. 2022; 399:1401–1410.

3

Böhm M, Kario K, Kandzari DE, et al. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial. The Lancet 2020; Published online March 29, 2020. DOI: 10.1016/ S0140–6736(20)30554-7.