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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Meshalkin Research Institute of Pathology of Circulation
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier:
NCT01873352
First received: June 5, 2013
Last updated: December 6, 2013
Last verified: December 2013

June 5, 2013
December 6, 2013
June 2013
December 2013   (final data collection date for primary outcome measure)
AAD-free freedom from AF recurrence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01873352 on ClinicalTrials.gov Archive Site
  • Freedom from AF recurrence (not-including the pre-defined 3 month blanking period) despite taking AADs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Blood pressure control between the two groups as compared to baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Blood pressure control between the two groups as compared to baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Differences in plasma norepinephrine and BNP measurements [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Differences in plasma norepinephrine and BNP measurements [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Differences in measures of LV hypertrophy/compliance (LV wall thickness, mitral inflow parameters) and LA size [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Procedure adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Serious adverse events throughout follow-up [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Total number of anti-hypertensive medications at study end, compared between the two treatment arms [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Renal Artery Denervation In Addition to Catheter Ablation To Eliminate Atrial Fibrillation
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Atrial Fibrillation
  • Hypertension
  • 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+RD
    Catheter ablation of atrial fibrillation plus renal sympathetic denervation
    Interventions:
    • Procedure: catheter ablation
    • Procedure: renal sympathetic denervation
  • Active Comparator: CA (control)
    Catheter ablation of atrial fibrillation (control group)
    Intervention: Procedure: catheter ablation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
June 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
United States,   Russian Federation
 
NCT01873352
RADCA01
Yes
Meshalkin Research Institute of Pathology of Circulation
Meshalkin Research Institute of Pathology of Circulation
Not Provided
Principal Investigator: Evgeny Pokushalov, MD, PhD State Research Institute of Circulation Pathology
Principal Investigator: Jonathan S. Steinberg, MD The Valley Health System and Columbia University College of Physicians & Surgeons
Meshalkin Research Institute of Pathology of Circulation
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP