SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study

Medtronic

Status: Completed

Conditions: Hypertension; Cardiovascular Diseases; Vascular Diseases

Treatments: Procedure: Sham Procedure; Device: Symplicity Spyral™ multi-electrode renal denervation system

Study type: Interventional

Funder types: Industry

Identifiers

NCT02439749

SPYRAL HTN-OFF MED

Details and patient eligibility

About

The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the absence of antihypertensive medications.

Enrollment: 366 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individual has office systolic blood pressure (SBP) ≥ 150 mmHg and <180 mmHg and a diastolic blood pressure (DBP) ≥ 90 mmHg after being off medications.
• Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥ 140 mmHg and < 170 mmHg.
• Individual is willing to discontinue current antihypertensive medications.

Exclusion criteria

• Individual lacks appropriate renal artery anatomy.
• Individual has estimated glomerular filtration rate (eGFR) of <45.
• Individual has type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus.
• Individual has one or more episodes of orthostatic hypotension.
• Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
• Individual has primary pulmonary hypertension.
• Individual is pregnant, nursing or planning to become pregnant.
• Individual has frequent intermittent or chronic pain that results in treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the month prior to enrollment.
• Individual has stable or unstable angina within 3 months of enrollment, myocardial infarction within 3 months of enrollment; heart failure, cerebrovascular accident or transient ischemic attack, or atrial fibrillation at any time.
• Individual works night shifts.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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366 participants in 2 patient groups

Renal Denervation

Experimental group

Description:

Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)

Treatment:

Device: Symplicity Spyral™ multi-electrode renal denervation system

Sham Procedure

Sham Comparator group

Description:

Renal angiography

Treatment:

Procedure: Sham Procedure