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Renal Artery Denervation In Addition to Catheter Ablation To Eliminate Atrial Fibrillation (ERADICATE--AF)

Primary Purpose

Atrial Fibrillation, Hypertension

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
catheter ablation
renal sympathetic denervation
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years of age
  • History of PAF and plans for a guideline-supported catheter ablation procedure. Paroxysmal AF is defined as AF with duration of 30 secs to 7 days.
  • History of significant hypertension (defined as SBP ≥130 mm Hg and/or DBP ≥80 mmHg) and receiving treatment with at least one anti-hypertensive medication
  • Renal vasculature accessible as determined by pre-procedural renal MRA
  • Willingness to comply with all post-procedural follow-up requirements and to sign informed consent

Exclusion Criteria:

  • Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation)
  • Prior left atrial ablation for an atrial arrhythmia
  • NYHA class IV congestive heart failure
  • Pers or longstanding Pers AF (duration > 7 days)
  • Renal artery anatomy that is ineligible for treatment
  • An estimated glomerular filtration rate (eGFR) < 45mL/min/1.73m2, using the MDRD calculation
  • Life expectancy <1 year for any medical condition

Sites / Locations

  • Jonathan S. Steinberg
  • State Research Institute of Circulation Pathology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

CA+RD

CA (control)

Arm Description

Catheter ablation of atrial fibrillation plus renal sympathetic denervation

Catheter ablation of atrial fibrillation (control group)

Outcomes

Primary Outcome Measures

AAD-free freedom from AF/atrial flutter/atrial tachycardia recurrence at least 30 seconds

Secondary Outcome Measures

Freedom from AF recurrence (not-including the pre-defined 3 month blanking period) despite taking AADs
Blood pressure control between the two groups as compared to baseline
Blood pressure control between the two groups as compared to baseline
Differences in measures of LV hypertrophy/compliance (LV wall thickness, mitral inflow parameters) and LA size
Procedure adverse events
Major adverse cardiac events (defined as a composite of: death, stroke, CHF hospitalization, clinically diagnosed thromboembolic events other than stroke and hemorrhage requiring transfusion)
Serious adverse events throughout follow-up
Total number of anti-hypertensive medications at study end, compared between the two treatment arms

Full Information

First Posted
June 5, 2013
Last Updated
August 30, 2019
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT01873352
Brief Title
Renal Artery Denervation In Addition to Catheter Ablation To Eliminate Atrial Fibrillation
Acronym
ERADICATE--AF
Official Title
Evaluate Renal Artery Denervation In Addition to Catheter Ablation To Eliminate Atrial Fibrillation (ERADICATE--AF) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
June 20, 2013 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this trial is to determine the role of renal sympathetic denervation in the prevention of atrial fibrillation (AF) recurrence in patients with hypertension for whom a catheter-based AF ablation procedure is planned. Patients will be randomized to either AF catheter ablation (usual therapy) or AF catheter ablation plus renal sympathetic denervation.

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
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
302 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CA+RD
Arm Type
Active Comparator
Arm Description
Catheter ablation of atrial fibrillation plus renal sympathetic denervation
Arm Title
CA (control)
Arm Type
Active Comparator
Arm Description
Catheter ablation of atrial fibrillation (control group)
Intervention Type
Procedure
Intervention Name(s)
catheter ablation
Intervention Description
Patient anesthesia will be administered according to standard EP lab protocol. Arterial and venous access will be achieved through cannulation of the right and/or left femoral arteries and veins as per the usual practice of the EP lab. Full systemic anticoagulation will be instituted as per standard hospital procedures to a target ACT of approximately 300 seconds or greater. Intravascular ultrasound may be used to assist in the positioning of study catheters during the procedure. The AF ablation procedure will be performed using a cryoballoon ablation catheter. Complete pulmonary vein isolation will be the goal of the ablation procedure and PV isolation must be confirmed by a multielectrode mapping catheter within each PV. Pulmonary vein isolation is the only intervention. A cavo-tricuspid isthmus line may be placed in patients with either a history of ECG-determined typical flutter or induced typical flutter during the procedure.
Intervention Type
Procedure
Intervention Name(s)
renal sympathetic denervation
Intervention Description
Right or left femoral artery access. Real-time 3D aorta-renal artery maps constructed with the use of a navigation system and ablation catheter. Mapping and ablation performed after PVI and under identical sedation protocol used for AF ablation. RF delivery of 6 watts to be applied discretely from the first distal main renal artery bifurcation all the way back to the ostium; RF duration of each delivery 1.5 mins; lesions delivered at multiple sites based on multipolar catheter position within renal artery. Use of specifically designed RF delivery system for renal artery denervation is mandatory (RDN). To confirm renal denervation, high-frequency stimulation (HFS) will be applied before the initial and after each RF delivery within the renal artery. Rectangular electrical stimuli will be delivered at the ostium of the targeted renal artery at a frequency of 20 Hz, with an amplitude 15 V and pulse duration of 10 ms for 10 secs.
Primary Outcome Measure Information:
Title
AAD-free freedom from AF/atrial flutter/atrial tachycardia recurrence at least 30 seconds
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Freedom from AF recurrence (not-including the pre-defined 3 month blanking period) despite taking AADs
Time Frame
12 months
Title
Blood pressure control between the two groups as compared to baseline
Time Frame
6 months
Title
Blood pressure control between the two groups as compared to baseline
Time Frame
12 months
Title
Differences in measures of LV hypertrophy/compliance (LV wall thickness, mitral inflow parameters) and LA size
Time Frame
12 months
Title
Procedure adverse events
Time Frame
12 months
Title
Major adverse cardiac events (defined as a composite of: death, stroke, CHF hospitalization, clinically diagnosed thromboembolic events other than stroke and hemorrhage requiring transfusion)
Time Frame
12 months
Title
Serious adverse events throughout follow-up
Time Frame
12 months
Title
Total number of anti-hypertensive medications at study end, compared between the two treatment arms
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years of age History of PAF and plans for a guideline-supported catheter ablation procedure. Paroxysmal AF is defined as AF with duration of 30 secs to 7 days. History of significant hypertension (defined as SBP ≥130 mm Hg and/or DBP ≥80 mmHg) and receiving treatment with at least one anti-hypertensive medication Renal vasculature accessible as determined by pre-procedural renal MRA Willingness to comply with all post-procedural follow-up requirements and to sign informed consent Exclusion Criteria: Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation) Prior left atrial ablation for an atrial arrhythmia NYHA class IV congestive heart failure Pers or longstanding Pers AF (duration > 7 days) Renal artery anatomy that is ineligible for treatment An estimated glomerular filtration rate (eGFR) < 45mL/min/1.73m2, using the MDRD calculation Life expectancy <1 year for any medical condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evgeny Pokushalov, MD, PhD
Organizational Affiliation
State Research Institute of Circulation Pathology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonathan S. Steinberg, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonathan S. Steinberg
City
Short Hills
State/Province
New Jersey
ZIP/Postal Code
07078
Country
United States
Facility Name
State Research Institute of Circulation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
31961420
Citation
Steinberg JS, Shabanov V, Ponomarev D, Losik D, Ivanickiy E, Kropotkin E, Polyakov K, Ptaszynski P, Keweloh B, Yao CJ, Pokushalov EA, Romanov AB. Effect of Renal Denervation and Catheter Ablation vs Catheter Ablation Alone on Atrial Fibrillation Recurrence Among Patients With Paroxysmal Atrial Fibrillation and Hypertension: The ERADICATE-AF Randomized Clinical Trial. JAMA. 2020 Jan 21;323(3):248-255. doi: 10.1001/jama.2019.21187. Erratum In: JAMA. 2020 Mar 3;323(9):896.
Results Reference
derived
Links:
URL
http://meshalkin.ru
Description
State Research Institute of Circulation Pathology Official Site

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Renal Artery Denervation In Addition to Catheter Ablation To Eliminate Atrial Fibrillation

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