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The objective of this study is to compare the elimination of atrial fibrillation in patients with recurrent atrial fibrillation despite prior pulmonary vein isolation (PVI) when undergoing repeat PVI (control) vs repeat PVI plus renal denervation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Redo PVI | Active Comparator | Therapeutic anticoagulation will be required for at least 3 weeks prior to ablation. An MRA will be performed to define cardiac and PV anatomy. Standard ablation technique will be employed. After gaining venous access, double transseptal puncture will be performed to permit left atrial access, guided by intracardiac ultrasound. A circular mapping catheter will be placed in each PV and any reconnections will be ablated by delivery of RF energy. Confirmation of re-isolation of all PVs will be performed at the conclusion of the procedure. |
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| PVI + RDN | Active Comparator | All patients who are randomized to Group II will undergo redo PVI exactly as described above. At the conclusion of PVI, RDN will be performed. Real-time 3-dimensional aorta-renal artery maps will be constructed with the use of the same navigation system and catheter used for PVI after femoral artery access. Both mapping and ablation will performed under the same modified sedation. RF ablations of 8 to 10 watts will be applied discretely from the first distal main renal artery bifurcation all the way back to the ostium, for 2 min, and up to 6 lesions (separated by ≥ 5 mm). Lesions will be made both longitudinally and rotationally within each renal artery. To confirm renal denervation, high-frequency stimulation (HFS) will be used before the initial and after each RF delivery within the renal artery. RDN will be considered to have been achieved when the sudden increase of blood pressure (≥ 15 mm Hg from invasive arterial monitoring) is absent. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Redo PVI | Procedure |
| ||
| PVI + RDN |
| Measure | Description | Time Frame |
|---|---|---|
| The absence of AF | The absence of AF at one year as assessed by prolonged ambulatory ECG monitoring post-ablation after 3 month blanking period has expired following the repeat ablation procedure. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic and diastolic blood pressures | 1 year | |
| procedural duration and complications | 1 year | |
| LV mass on echocardiogram |
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Inclusion Criteria:
Exclusion Criteria:
Persistent AF after prior ablation
Congestive heart failure (NYHA III-IV functional class)
Left ventricle ejection fraction < 35%
Left atrial diameter >55 mm
An estimated glomerular filtration rate (eGFR) < 45mL/min/1.73m2, using the MDRD calculation
Renal arteries unsuitable for RDN:
Unwillingness to participate
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Evgeny Pokushalov, MD, PhD | Contact | +79139254858 | e.pokushalov@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan S. Steinberg, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Active, not recruiting | Rochester | New York | United States | ||
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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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|
| 1 year |
| State Research Institute of Circulation Pathology |
| Recruiting |
| Novosibirsk |
| 630055 |
| Russia |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |