N/A
N=70
Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation
Atrial Fibrillation · Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02064764 ↗Enrolled (actual)
70
Serious AEs
52.9%
Results posted
Feb 2024
Primary outcome: Primary: Proportion of Subjects in Each Arm That Experience Safety Composite Events — 1; 3 Participants — p=0.28
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter (Device); Arctic Front Advance™ Cardiac Cryoablation System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Vascular
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects in Each Arm That Experience Safety Composite Events |
1; 3 | 0.28 |
| PRIMARY Proportion of Patients With Chronic Treatment Success |
11; 10 | 0.7348 |
| SECONDARY Change in Office Systolic and Diastolic Blood Pressure at 6 Months From Baseline |
-11.6; -13.3; -5.6; -5.8 | — |
| SECONDARY Difference in Heart Rate at 6 Months and Baseline |
-1.9; 1.8 | — |
| SECONDARY Procedural Measures |
25.4; 34; 66.2; 68.3; 51.2; 119.5 | — |
| SECONDARY Proportion of Participants With Symptoms at 6 Months Between Study Arms |
17; 11; 6; 4; 29; 27 | — |
| SECONDARY Rate of Chronic Treatment Success (Primary Effectiveness Endpoint) for Subjects Off of Class I and III Anti-arrhythmic Drugs Following the Blanking Period. |
13; 16; 7; 8 | — |
| SECONDARY Percent of Time in AF Burden Over All Follow-up Occurring After the Blanking Period |
2.78; 1.75 | — |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02064764). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.