SPYRAL HTN-OFF MED PIVOTAL TRIAL

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)

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

TRIAL DATA

The SPYRAL Off-Med pivotal trial met its secondary efficacy endpoint, showing clinically significant blood pressure reductions at three months.1* 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.1

Bar charts comparing 24-hour and office systolic blood pressure (SBP) from the SPYRAL OFF-MED pivotal trial.
SPYRAL OFF-MED pivotal trial graph comparing 24-hour systolic blood pressure data with Medtronic RDN baseline data.
SPYRAL OFF-MED pivotal trial graph comparing 24-hour systolic blood pressure data with sham data.

HYPERTENSION 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)

PRIMARY OUTCOME MEASURES

Decorative image

Acute and chronic safety by evaluating incidence of major adverse events from baseline to one month post-procedure or six months for new renal artery stenosis

 

Decorative image

Change in systolic blood pressure as measured by 24-hour ambulatory blood pressure monitoring (ABPM) from baseline to three months post-procedure

 

Diagram covering pathway for high blood pressure (HBP) screening and renal denervation (RDN) treatment as part of the SPYRAL Pivotal HTN-OFF MED Trial.

DESIGN DETAILS

  • Estimated Enrollment: 433 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

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

*

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

†

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

‡

ANCOVA Adjusted.

1

Böhm M, Kario K, Townsend R, et al. Catheter-based Renal Denervation in the Absence of Antihypertensive Medications: Primary Results from the SPYRAL HTN-OFF MED Pivotal Trial. Presented at ACC. 2020.

2

Only for patients discontinuing anti-hypertensive medications.

3

According to scheduling.

4

Drug testing to ensure no medications are present.

5

Optional follow-up at weeks 6 and/or 10 if the patient is not controlled.

6

Only for patients with BP ≥140 mm Hg at 3M.

7

Drug testing to ensure prescribed medications are present (if on drug).

8

6 and 12 month renal imaging.