Clinical trial NCT01952743: Renal Denervation Therapy in Hypertensive Patients Undergoing A-Fib Ablation
Official title: Concomitant Renal Denervation Therapy in Hypertensive Patients Undergoing Atrial Fibrillation Ablation - A Feasibility Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Hypertension
Keywords: Atrial Fibrillation
Hypertension
Renal Denervation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-09-30
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: We propose a pilot study to assess safety and benefit of renal artery ablation at the time of planned atrial fibrillation ablation.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Atrial fibrillation (AF) Time to recurrence and Burden
timeFrame: 1 year
measure: Hypertension control
timeFrame: 1 year
Secondary outcomes:
measure: Glomerular Filtration Rate (GFR) at 3, 6 and 12 months
timeFrame: 1 year
measure: Renal artery complications by Crosssectional Imaging (Magnetic Resonance Imaging or computed tomography
timeFrame: 3months
measure: Quality of life scores (MAFSI- Mayo Atrial Fibrillation Symptom Index)
timeFrame: 1 year
measure: Change in left atrial volume parameters
timeFrame: 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic, Rochester, MN
name: Siva K. Mulpuru, M.D.
role: PRINCIPAL_INVESTIGATOR
References: