Renal Artery Denervation In Addition to Catheter Ablation To Eliminate Atrial Fibrillation
| Status: | Recruiting |
|---|---|
| Conditions: | Atrial Fibrillation, High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | June 2013 |
| End Date: | February 2017 |
Evaluate Renal Artery Denervation In Addition to Catheter Ablation To Eliminate Atrial Fibrillation (ERADICATE--AF) Trial
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.
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.
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
2
sites
University of Rochester The University of Rochester is one of the country's top-tier research universities....
Click here to add this to my saved trials
Novosibirsk, 63005
Principal Investigator: Evgeny Pokushalov, MD, PhD
Phone: +79139254858
Click here to add this to my saved trials