Renal Denervation Therapy in Hypertensive Patients Undergoing A-Fib Ablation

NCT ID: NCT01952743

Last Updated: 2017-03-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-10-31

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.

Conditions

Atrial Fibrillation; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AF Ablation alone

Clinical AF ablation performed as deemed appropriate by operator

Group Type: ACTIVE_COMPARATOR

AF ablation alone

Intervention Type: PROCEDURE

Pulmonary vein isolation (PVI) is performed as per operator preference by previously described techniques.

AF ablation with Renal Denervation

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

Group Type: EXPERIMENTAL

AF ablation with Renal Denervation

Intervention Type: PROCEDURE

Pulmonary vein isolation (PVI) is performed as per operator preference by previously described techniques. Both mapping and ablation are performed under general anesthesia. The use of standard electrophysiology ablation catheter to perform renal artery ablation in hypertensive patients has been previously described. UP to 2 minutes of RF energy (10W with irrigation flow of 17 ml/min) are delivered at each location and up to 6 lesions for each artery on the longitudinal and rotational axis. Renal denervation is performed on both vascular pedicles after clinical AF ablation in patients assigned to the intervention arm.

Interventions

AF ablation with Renal Denervation

Pulmonary vein isolation (PVI) is performed as per operator preference by previously described techniques. Both mapping and ablation are performed under general anesthesia. The use of standard electrophysiology ablation catheter to perform renal artery ablation in hypertensive patients has been previously described. UP to 2 minutes of RF energy (10W with irrigation flow of 17 ml/min) are delivered at each location and up to 6 lesions for each artery on the longitudinal and rotational axis. Renal denervation is performed on both vascular pedicles after clinical AF ablation in patients assigned to the intervention arm.

Intervention Type: PROCEDURE

AF ablation alone

Pulmonary vein isolation (PVI) is performed as per operator preference by previously described techniques.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Siva Mulpuru

OTHER

Sponsor Role: lead

Responsible Party

Siva Mulpuru

M.D., Assistant Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Siva K. Mulpuru, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic, Rochester, MN

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

12-009062

Identifier Type: -

Identifier Source: org_study_id