Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation (Symplicity AF)

Medtronic

Status: Completed

Conditions: Hypertension; Atrial Fibrillation

Treatments: Device: Arctic Front Advance™ Cardiac Cryoablation System; Device: Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT02064764

Symplicity AF

Details and patient eligibility

About

The purpose of this clinical study is to evaluate the feasibility of performing both renal nerve denervation and pulmonary vein isolation on the same patient with the intent of characterizing both safety and effectiveness in a paroxysmal and persistent atrial fibrillation population with hypertension. To assess safety, the study will measure the occurrence of a composite safety endpoint and, to assess effectiveness, the study will measure freedom of chronic treatment failure through a minimum of six months of follow-up.

Enrollment: 102 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Drug refractory recurrent symptomatic paroxysmal or persistent atrial fibrillation
• Office-based systolic blood pressure of ≥140 mm Hg based despite treatment with 1 or more antihypertensive medications
• Age 18 years to 80 years old.

Key Exclusion Criteria:

• Renal artery anatomy that is ineligible for treatment including: Lacks at least one renal artery for each kidney with ≥3 mm diameter and minimum treatable length per the Spyral Instructions for Use, Renal artery stenosis (>50%) or renal artery aneurysm in either renal artery, A history of prior renal artery intervention including balloon angioplasty or stenting, Renal artery which contain calcification which does not allow at least four radio frequency ablations to be delivered , Diffuse fibromuscular dysplasia (FMD) or FMD which does not allow at least four radio frequency ablations to be delivered; FMD defined as visible beading of the artery on angiography , Unilateral kidney.
• Estimated Glomerular Filtration Rate of <30 mL/min/1.73m2.
• Pregnant, nursing or planning to be pregnant. (Female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to angiography).
• Currently enrolled or plans to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent studies is allowed when documented pre-approval is obtained from the Medtronic study manager.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

102 participants in 2 patient groups

Cryoablation only

Active Comparator group

Description:

Pulmonary vein isolation

Treatment:

Device: Arctic Front Advance™ Cardiac Cryoablation System

Cryoablation and renal nerve denervation

Experimental group

Description:

Pulmonary vein isolation plus renal nerve denervation

Treatment:

Device: Arctic Front Advance™ Cardiac Cryoablation System

Device: Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter