Renal Denervation Therapy in Hypertensive Patients Undergoing A-Fib Ablation

NCT01952743 | Terminated

• 1 other identifier: 12-009062
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation; Hypertension

Keywords

Atrial Fibrillation; Hypertension; Renal Denervation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• 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

Study Arms (2)

AF Ablation alone

ACTIVE COMPARATOR

Clinical AF ablation performed as deemed appropriate by operator

Procedure: AF ablation alone

AF ablation with Renal Denervation

EXPERIMENTAL

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

Procedure: AF ablation with Renal Denervation

Interventions

AF ablation with Renal Denervation 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.

AF ablation with Renal Denervation

AF ablation alone PROCEDURE

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

AF Ablation alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Hypertension (\>140/80 mm Hg) on treatment with at least 1 hypertensive medication.
• GFR \>60ml/dl using Cockcroft- Gault equation

You may not qualify if:

• Secondary causes of hypertension
• Severe renal artery stenosis or dual renal arteries
• Congestive heart failure with NYHA class III or IV status
• EF\< 35%
• LA Diameter \>6 cm
• Previous AF ablation
• Previous renal artery stent or angioplasty
• Severe contrast allergy
• Inability to give informed consent
• Solitary kidney

Sponsors & Collaborators

• Siva Mulpuru: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Hypertension

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Study Officials

• Siva K. Mulpuru, M.D.

  Mayo Clinic, Rochester, MN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., Assistant Professor of Medicine

Study Record Dates

• First Submitted: September 23, 2013
• First Posted: September 30, 2013
• Study Start: September 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2015
• Last Updated: March 22, 2017

Record last verified: 2017-03

Locations

US (1)