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

Hypertension Clinical Trial

— Symplicity AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02064764
• Other study ID #: Symplicity AF
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: April 19, 2021

Study information

• Verified date: January 2024
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: April 19, 2021
• Est. primary completion date: April 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Hypertension

Intervention

Device:
• Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter

• Arctic Front Advance™ Cardiac Cryoablation System

Locations

Country	Name	City	State
Germany	Universitätsklinikum des Saarlandes	Homburg
United States	Lahey Hospital and Medical Center	Burlington	Massachusetts
United States	The Ohio State University	Columbus	Ohio
United States	Doylestown Hospital	Doylestown	Pennsylvania
United States	UPHS-Marquette	Marquette	Michigan
United States	NYU Langone Medical Center	New York	New York
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Mercy Medical Group-Cardiology	Sacramento	California
United States	Swedish Medical Center Cherry Hill	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Subjects in Each Arm That Experience Safety Composite Events	Characterize the rate of safety composite events, (End stage renal disease, Death, Significant Embolic Event, Renal Artery Perforation or Dissection Requiring Intervention, Vascular Complications, Hospitalization for Hypertensive Crisis, New Renal Artery Stenosis, Cardiac Damage, Pulmonary Vein Stenosis, Atrio-Esophageal Fistula, Arrhythmia, Persistent Phrenic Nerve Palsy), within each of the two study arms and also characterize the difference in the rates between study arms. Each event in the composite has its own time frame, either one month or six months post procedure.	Up to one or six months post procedure depending on the event
Primary	Proportion of Patients With Chronic Treatment Success	Chronic treatment success is freedom from chronic treatment failure. Chronic treatment failure is defined as the occurrence of either a documented episode of AF lasting 2 or more minutes (as measured by an implantable loop recorder) or an intervention for AF.	Minimum of six months
Secondary	Change in Office Systolic and Diastolic Blood Pressure at 6 Months From Baseline	Compare the difference of office systolic and diastolic blood pressure at 6 months and baseline between study arms.	6 months
Secondary	Difference in Heart Rate at 6 Months and Baseline	Compare the difference in heart rate using the 6 month follow-up measurement and baseline visit measurement. These values will then be compared between study arms.	6 months
Secondary	Procedural Measures	Elapsed fluoroscopy time and cryocatheter procedure time between study arms. Renal Denervation Procedure Time and Total Procedural Time will be reported only for the Cryoablation and Renal Denervation group.	Procedure
Secondary	Proportion of Participants With Symptoms at 6 Months Between Study Arms	The endpoints for this objective are presence of the following arrhythmic symptoms as recorded at the 6-month visit through discussion with the patient at the time of the visit: Dizziness; Palpitations; Rapid heart beat; Dyspnea; Fatigue; Syncope; Other	6 months
Secondary	Rate of Chronic Treatment Success (Primary Effectiveness Endpoint) for Subjects Off of Class I and III Anti-arrhythmic Drugs Following the Blanking Period.	Compare the rate of chronic treatment success (primary effectiveness endpoint) between study arms for subjects off of Class I and III anti-arrhythmic drugs following the blanking period.	6 months
Secondary	Percent of Time in AF Burden Over All Follow-up Occurring After the Blanking Period	Compare the Percent of time in AF burden over all follow-up occurring after the blanking period between study arms.	91 days after the cryoablation procedure date until the last Reveal LINQ device data date.