Renal Denervation Therapy in Hypertensive Patients Undergoing A-Fib Ablation

Siva Mulpuru

Status: Terminated

Conditions: Hypertension; Atrial Fibrillation

Treatments: Procedure: AF ablation with Renal Denervation; Procedure: AF ablation alone

Study type: Interventional

Funder types: Other

Identifiers

NCT01952743

12-009062

Details and patient eligibility

About

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

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

AF Ablation alone

Active Comparator group

Description:

Clinical AF ablation performed as deemed appropriate by operator

Treatment:

Procedure: AF ablation alone

AF ablation with Renal Denervation

Experimental group

Description:

Renal denervation performed using the same ablation catheter after clinical AF ablation

Treatment:

Procedure: AF ablation with Renal Denervation