Status:
COMPLETED
Renal Artery Denervation In Addition to Catheter Ablation To Eliminate Atrial Fibrillation
Lead Sponsor:
Meshalkin Research Institute of Pathology of Circulation
Conditions:
Atrial Fibrillation
Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 A...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 20 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT01873352
Start Date
June 20 2013
End Date
March 1 2019
Last Update
September 4 2019
Active Locations (2)
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1
Jonathan S. Steinberg
Short Hills, New Jersey, United States, 07078
2
State Research Institute of Circulation Pathology
Novosibirsk, Russia, 630055