NCT01873352

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
302

participants targeted

Target at P50-P75 for phase_3 atrial-fibrillation

Timeline
Completed

Started Jun 2013

Longer than P75 for phase_3 atrial-fibrillation

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2013

Completed
10 days until next milestone

Study Start

First participant enrolled

June 20, 2013

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

September 4, 2019

Status Verified

June 1, 2019

Enrollment Period

5.7 years

First QC Date

June 5, 2013

Last Update Submit

August 30, 2019

Conditions

Atrial FibrillationHypertension

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (8)

  • Freedom from AF recurrence (not-including the pre-defined 3 month blanking period) despite taking AADs

    12 months

  • Blood pressure control between the two groups as compared to baseline

    6 months

  • Blood pressure control between the two groups as compared to baseline

    12 months

  • Differences in measures of LV hypertrophy/compliance (LV wall thickness, mitral inflow parameters) and LA size

    12 months

  • Procedure adverse events

    12 months

  • +3 more secondary outcomes

Study Arms (2)

CA+RD

ACTIVE COMPARATOR

Catheter ablation of atrial fibrillation plus renal sympathetic denervation

Procedure: catheter ablationProcedure: renal sympathetic denervation

CA (control)

ACTIVE COMPARATOR

Catheter ablation of atrial fibrillation (control group)

Procedure: catheter ablation

Interventions

catheter ablationPROCEDURE

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.

CA (control)CA+RD
renal sympathetic denervationPROCEDURE

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.

CA+RD

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jonathan S. Steinberg

Short Hills, New Jersey, 07078, United States

Location

State Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

Location

Related Publications (1)

  • 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.

    PMID: 31961420DERIVED

Related Links

MeSH Terms

Conditions

Atrial FibrillationHypertension

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Evgeny Pokushalov, MD, PhD

    State Research Institute of Circulation Pathology

    PRINCIPAL INVESTIGATOR

  • Jonathan S. Steinberg, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2013

First Posted

June 10, 2013

Study Start

June 20, 2013

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

September 4, 2019

Record last verified: 2019-06

Locations

RU(1)US(1)