Comparison of Redo PVI With vs. Without Renal Denervation for Recurrent AF After Initial PVI
NCT ID: NCT01959997
Last Updated: 2015-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2013-09-30
2016-09-30
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
DOUBLE
Study Groups
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Redo PVI
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.
Redo PVI
PVI + RDN
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.
PVI + RDN
Interventions
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Redo PVI
PVI + RDN
Eligibility Criteria
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Inclusion Criteria
* Recurrent symptomatic paroxysmal AF despite prior PVI
* History of essential hypertension requiring at least 2 chronic antihypertensive medications
Exclusion Criteria
* 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:
1. Inability to access renal vasculature
2. Main renal arteries \< 4 mm in diameter or \< 20 mm in length.
3. Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery
4. A history of prior renal artery intervention including balloon angioplasty or stenting that precludes a possibility of ablation treatment
5. Multiple main renal arteries to either kidney
* Unwillingness to participate
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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Jonathan S. Steinberg, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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University of Rochester
Rochester, New York, United States
State Research Institute of Circulation Pathology
Novosibirsk, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RD_REDO_032
Identifier Type: -
Identifier Source: org_study_id
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