Renal Denervation Therapy in Hypertensive Patients Undergoing A-Fib Ablation
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 12-009062
NCT ID: NCT01952743
Sponsor Protocol Number: 12-009062
About this study
We propose a pilot study to assess safety and benefit of renal artery ablation at the time of planned atrial fibrillation ablation.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Paroxysmal and Persistent Atrial Fibrillation refractory eligible for AF ablation as per HRS/ECAS/EHRA consensus statement:
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Siva Mulpuru, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available