Renal Denervation Therapy in Hypertensive Patients Undergoing A-Fib Ablation
| Status: | Terminated |
|---|---|
| Conditions: | Atrial Fibrillation, High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/23/2017 |
| Start Date: | September 2013 |
| End Date: | October 2015 |
Concomitant Renal Denervation Therapy in Hypertensive Patients Undergoing Atrial Fibrillation Ablation - A Feasibility Study
We propose a pilot study to assess safety and benefit of renal artery ablation at the time
of planned atrial fibrillation ablation.
of planned atrial fibrillation ablation.
Symptomatic atrial fibrillation (AF) refractory to anti-arrhythmic drugs is commonly treated
with ablation therapy. Pulmonary vein isolation along with additional substrate medication
is commonly performed during ablation procedures is associated with 60-80% success rate for
maintenance of sinus rhythm. After AF ablation hypertension (HTN) is a strong predictor for
recurrence of atrial fibrillation. Drug resistant hypertension can be effectively treated
with catheter based renal denervation therapy. Our primary hypothesis is concomitant renal
denervation therapy along with AF ablation is associated with improvement in success rates
of AF ablation along with adequate control of blood pressure. The specific objectives of
this study are to prospectively compare success rates, time to AF recurrence, AF burden and
blood pressure controls in patients randomized to concomitant renal denervation arm when
compared to patients with AF ablation alone.
with ablation therapy. Pulmonary vein isolation along with additional substrate medication
is commonly performed during ablation procedures is associated with 60-80% success rate for
maintenance of sinus rhythm. After AF ablation hypertension (HTN) is a strong predictor for
recurrence of atrial fibrillation. Drug resistant hypertension can be effectively treated
with catheter based renal denervation therapy. Our primary hypothesis is concomitant renal
denervation therapy along with AF ablation is associated with improvement in success rates
of AF ablation along with adequate control of blood pressure. The specific objectives of
this study are to prospectively compare success rates, time to AF recurrence, AF burden and
blood pressure controls in patients randomized to concomitant renal denervation arm when
compared to patients with AF ablation alone.
Inclusion Criteria:
1. Paroxysmal and Persistent Atrial Fibrillation refractory eligible for AF ablation as
per HRS/ECAS/EHRA consensus statement.[23] Paroxysmal AF is defined as two or more
episodes of AF lasting less than 7 days in duration during the last 6 months before
enrollment. Persistent AF is defined as AF lasting more than 7 days or requiring
cardioversion for termination.
2. Hypertension (>140/80 mm Hg) on treatment with at least 1 hypertensive medication.
3. GFR >60ml/dl using Cockcroft- Gault equation
Exclusion Criteria:
1. Secondary causes of hypertension
2. Severe renal artery stenosis or dual renal arteries
3. Congestive heart failure with NYHA class III or IV status
4. EF< 35%
5. LA Diameter >6 cm
6. Previous AF ablation
7. Previous renal artery stent or angioplasty
8. Severe contrast allergy
9. Inability to give informed consent
10. Solitary kidney
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