Renal Artery Denervation In Addition to Catheter Ablation To Eliminate Atrial Fibrillation
Completed · Phase 3
Conditions studied: Atrial Fibrillation, Hypertension
In brief
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.
Key facts
- Study ID
- NCT01873352
- Run by
- Meshalkin Research Institute of Pathology of Circulation
- People needed
- 302
- Starts
- 2013-06-20
- Expected to finish
- 2019-03-01
- Last updated by the study team
- 2019-09-04
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Jonathan S. Steinberg — Short Hills, New Jersey, United States
- State Research Institute of Circulation Pathology — Novosibirsk, Russia
Full record on ClinicalTrials.gov
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