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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CA+RD | Active Comparator | Catheter ablation of atrial fibrillation plus renal sympathetic denervation |
|
| CA (control) | Active Comparator | Catheter ablation of atrial fibrillation (control group) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| catheter ablation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| AAD-free freedom from AF/atrial flutter/atrial tachycardia recurrence at least 30 seconds | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evgeny Pokushalov, MD, PhD | State Research Institute of Circulation Pathology | Principal Investigator |
| Jonathan S. Steinberg, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jonathan S. Steinberg | Short Hills | New Jersey | 07078 | United States | ||
| State Research Institute of Circulation Pathology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31961420 | Derived | 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. |
| Label | URL |
|---|---|
| State Research Institute of Circulation Pathology Official Site | View source |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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|
| renal sympathetic denervation | Procedure | 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. |
|
| 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 |
| Major adverse cardiac events (defined as a composite of: death, stroke, CHF hospitalization, clinically diagnosed thromboembolic events other than stroke and hemorrhage requiring transfusion) | 12 months |
| Serious adverse events throughout follow-up | 12 months |
| Total number of anti-hypertensive medications at study end, compared between the two treatment arms | 12 months |
| Novosibirsk |
| 630055 |
| Russia |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D013514 |
| Surgical Procedures, Operative |