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

Primary Purpose

Atrial Fibrillation, Hypertension

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter
Arctic Front Advance™ Cardiac Cryoablation System
Sponsored by
Medtronic Vascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mercy Medical Group-Cardiology
  • Lahey Hospital and Medical Center
  • UPHS-Marquette
  • NYU Langone Medical Center
  • The Ohio State University
  • Doylestown Hospital
  • University of Pittsburgh Medical Center
  • Virginia Mason Medical Center
  • Swedish Medical Center Cherry Hill
  • Universitätsklinikum des Saarlandes

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cryoablation only

Cryoablation and renal nerve denervation

Arm Description

Pulmonary vein isolation

Pulmonary vein isolation plus renal nerve denervation

Outcomes

Primary Outcome Measures

Safety composite events
The objective characterizes the rate of safety composite events, adjudicated as a serious adverse event, within each of the two study arms and also characterizes 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.
Rate of chronic treatment success between study arms
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 30 seconds or longer or an intervention for AF.

Secondary Outcome Measures

Full Information

First Posted
February 13, 2014
Last Updated
April 24, 2023
Sponsor
Medtronic Vascular
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1. Study Identification

Unique Protocol Identification Number
NCT02064764
Brief Title
Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation
Acronym
Symplicity AF
Official Title
Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
April 19, 2021 (Actual)
Study Completion Date
April 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Vascular

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cryoablation only
Arm Type
Active Comparator
Arm Description
Pulmonary vein isolation
Arm Title
Cryoablation and renal nerve denervation
Arm Type
Experimental
Arm Description
Pulmonary vein isolation plus renal nerve denervation
Intervention Type
Device
Intervention Name(s)
Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter
Intervention Type
Device
Intervention Name(s)
Arctic Front Advance™ Cardiac Cryoablation System
Primary Outcome Measure Information:
Title
Safety composite events
Description
The objective characterizes the rate of safety composite events, adjudicated as a serious adverse event, within each of the two study arms and also characterizes 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.
Time Frame
Up to one or six months post procedure depending on the event
Title
Rate of chronic treatment success between study arms
Description
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 30 seconds or longer or an intervention for AF.
Time Frame
Minimum of six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry Chinitz, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy Medical Group-Cardiology
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Lahey Hospital and Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
UPHS-Marquette
City
Marquette
State/Province
Michigan
ZIP/Postal Code
49855
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Doylestown Hospital
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Swedish Medical Center Cherry Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122-5711
Country
United States
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg
ZIP/Postal Code
66421
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
34269911
Citation
Younis A, Steinberg JS. Renal Denervation for Patients With Atrial Fibrillation. Curr Cardiol Rep. 2021 Jul 16;23(9):126. doi: 10.1007/s11886-021-01558-4.
Results Reference
derived

Learn more about this trial

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

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