Renal Artery Denervation In Addition to Catheter Ablation To Eliminate Atrial Fibrillation
NCT ID: NCT01873352
Last Updated: 2019-09-04
Study Results
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Basic Information
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COMPLETED
PHASE3
302 participants
INTERVENTIONAL
2013-06-20
2019-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CA+RD
Catheter ablation of atrial fibrillation plus renal sympathetic denervation
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.
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.
CA (control)
Catheter ablation of atrial fibrillation (control group)
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Meshalkin Research Institute of Pathology of Circulation
NETWORK
Responsible Party
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Principal Investigators
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Evgeny Pokushalov, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
State Research Institute of Circulation Pathology
Jonathan S. Steinberg, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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Jonathan S. Steinberg
Short Hills, New Jersey, United States
State Research Institute of Circulation Pathology
Novosibirsk, , Russia
Countries
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References
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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.
Related Links
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State Research Institute of Circulation Pathology Official Site
Other Identifiers
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RADCA01
Identifier Type: -
Identifier Source: org_study_id
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