Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation

Status:	Recruiting
Conditions:	Atrial Fibrillation, High Blood Pressure (Hypertension)
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - 80
Updated:	3/8/2019
Start Date:	February 2015
End Date:	July 2019
Contact:	Study Manager
Phone:	+17635269751

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.

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.

We found this trial at

sites

Massachusetts General Hospital

185 Cambridge Street
Boston, Massachusetts 02114

617-724-5200