Back to resultsRenal Denervation Therapy in Hypertensive Patients Undergoing A-Fib Ablation
Primary Purpose
Atrial Fibrillation, Hypertension
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AF ablation with Renal Denervation
AF ablation alone
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Hypertension, Renal Denervation
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
AF Ablation alone
AF ablation with Renal Denervation
Arm Description
Clinical AF ablation performed as deemed appropriate by operator
Renal denervation performed using the same ablation catheter after clinical AF ablation
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Glomerular Filtration Rate (GFR) at 3, 6 and 12 months
Renal artery complications by Crosssectional Imaging (Magnetic Resonance Imaging or computed tomography
Quality of life scores (MAFSI- Mayo Atrial Fibrillation Symptom Index)
Change in left atrial volume parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01952743
Brief Title
Renal Denervation Therapy in Hypertensive Patients Undergoing A-Fib Ablation
Official Title
Concomitant Renal Denervation Therapy in Hypertensive Patients Undergoing Atrial Fibrillation Ablation - A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Lack of efficacy with renal denervation in multicenter trials
Study Start Date
September 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Siva Mulpuru
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Hypertension
Keywords
Atrial Fibrillation, Hypertension, Renal Denervation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AF Ablation alone
Arm Type
Active Comparator
Arm Description
Clinical AF ablation performed as deemed appropriate by operator
Arm Title
AF ablation with Renal Denervation
Arm Type
Experimental
Arm Description
Renal denervation performed using the same ablation catheter after clinical AF ablation
Intervention Type
Procedure
Intervention Name(s)
AF ablation with Renal Denervation
Intervention Description
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
Intervention Name(s)
AF ablation alone
Intervention Description
Pulmonary vein isolation (PVI) is performed as per operator preference by previously described techniques.
Primary Outcome Measure Information:
Title
Atrial fibrillation (AF) Time to recurrence and Burden
Description
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.
Time Frame
1 year
Title
Hypertension control
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Glomerular Filtration Rate (GFR) at 3, 6 and 12 months
Time Frame
1 year
Title
Renal artery complications by Crosssectional Imaging (Magnetic Resonance Imaging or computed tomography
Time Frame
3months
Title
Quality of life scores (MAFSI- Mayo Atrial Fibrillation Symptom Index)
Time Frame
1 year
Title
Change in left atrial volume parameters
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siva K. Mulpuru, M.D.
Organizational Affiliation
Mayo Clinic, Rochester, MN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Renal Denervation Therapy in Hypertensive Patients Undergoing A-Fib Ablation
We'll reach out to this number within 24 hrs