Renal Denervation Therapy in Hypertensive Patients Undergoing A-Fib Ablation

Hypertension Clinical Trial

Official title:

Concomitant Renal Denervation Therapy in Hypertensive Patients Undergoing Atrial Fibrillation Ablation - A Feasibility Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01952743
• Other study ID #: 12-009062
• Status: Terminated
• Phase: N/A
• First received: September 23, 2013
• Last updated: March 21, 2017
• Start date: September 2013
• Est. completion date: October 2015

Study information

• Verified date: March 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: October 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Hypertension

Intervention

Procedure:
• 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.
• AF ablation alone
Pulmonary vein isolation (PVI) is performed as per operator preference by previously described techniques.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Siva Mulpuru

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial fibrillation (AF) Time to recurrence and Burden	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.	1 year
Primary	Hypertension control	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.	1 year
Secondary	Glomerular Filtration Rate (GFR) at 3, 6 and 12 months		1 year
Secondary	Renal artery complications by Crosssectional Imaging (Magnetic Resonance Imaging or computed tomography		3months
Secondary	Quality of life scores (MAFSI- Mayo Atrial Fibrillation Symptom Index)		1 year
Secondary	Change in left atrial volume parameters		1 year