Renal Denervation Therapy in Hypertensive Patients Undergoing A-Fib Ablation

Not Applicable

Terminated

• Conditions: Hypertension; Atrial Fibrillation
• Interventions: Procedure: AF ablation alone; Procedure: AF ablation with Renal Denervation

• Registration Number: NCT01952743
• Lead Sponsor: Siva Mulpuru

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-23
• Study First Submitted QC: 2013-09-25
• Study First Posted: 2013-09-30
• Primary Completion: 2014-10
• Study Completion: 2015-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
AF Ablation alone	AF ablation alone	Clinical AF ablation performed as deemed appropriate by operator
AF ablation with Renal Denervation	AF ablation with Renal Denervation	Renal denervation performed using the same ablation catheter after clinical AF ablation

Primary Outcome Measures

Name	Time	Method
Atrial fibrillation (AF) Time to recurrence and Burden	1 year	After 3 months of blanking period, time to recurrence of atrial arrhythmia lasting more than 30 seconds is measured during follow up. (Atrial fibrillation)AF burden is assessed on a 7 day duration event monitor. Electrocardiogram (EKG) or Event monitor strips will be evaluated by independent board certified physicians.
Hypertension control	1 year	BP is obtained as per Joint National Committee (JNC 7) standards at 3, 6 and 12 month visits of follow up. Information regarding titration of antihypertensives or reduction in the number of medications to adequately control blood pressure is collected.

Secondary Outcome Measures

Name	Time	Method
Glomerular Filtration Rate (GFR) at 3, 6 and 12 months	1 year
Renal artery complications by Crosssectional Imaging (Magnetic Resonance Imaging or computed tomography	3months
Quality of life scores (MAFSI- Mayo Atrial Fibrillation Symptom Index)	1 year
Change in left atrial volume parameters	1 year

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States