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

August 30, 2019 updated by: Meshalkin Research Institute of Pathology of Circulation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

302

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Novosibirsk, Russian Federation, 630055
        • State Research Institute of Circulation Pathology
  • United States
    • New Jersey
      • Short Hills, New Jersey, United States, 07078
        • Jonathan S. Steinberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CA+RD
Catheter ablation of atrial fibrillation plus renal sympathetic denervation
Procedure: catheter ablation
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.
Procedure: renal sympathetic denervation
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.
Active Comparator: CA (control)
Catheter ablation of atrial fibrillation (control group)
Procedure: catheter ablation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AAD-free freedom from AF/atrial flutter/atrial tachycardia recurrence at least 30 seconds
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Freedom from AF recurrence (not-including the pre-defined 3 month blanking period) despite taking AADs
Time Frame: 12 months
12 months
Blood pressure control between the two groups as compared to baseline
Time Frame: 6 months
6 months
Blood pressure control between the two groups as compared to baseline
Time Frame: 12 months
12 months
Differences in measures of LV hypertrophy/compliance (LV wall thickness, mitral inflow parameters) and LA size
Time Frame: 12 months
12 months
Procedure adverse events
Time Frame: 12 months
12 months
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
12 months
Serious adverse events throughout follow-up
Time Frame: 12 months
12 months
Total number of anti-hypertensive medications at study end, compared between the two treatment arms
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Investigators

  • Principal Investigator: Evgeny Pokushalov, MD, PhD, State Research Institute of Circulation Pathology
  • Principal Investigator: Jonathan S. Steinberg, MD, University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2013

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

June 5, 2013

First Submitted That Met QC Criteria

June 5, 2013

First Posted (Estimate)

June 10, 2013

Study Record Updates

Last Update Posted (Actual)

September 4, 2019

Last Update Submitted That Met QC Criteria

August 30, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RADCA01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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