Treatment of Atrial Fibrillation in Patients by Pulmonary Vein Isolation in Combination With Renal Denervation or Pulmonary Vein Isolation Only
NCT02115100 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 145
Last updated 2022-07-12
Summary
Prospective, randomized, controlled, multicenter, international clinical trial. The study population consist of patients with paroxysmal or persistent atrial fibrillation with out range hypertension or signs of sympathetic overdrive. Patient will be randomized into one of the following two groups.
group 1 : patients will undergo pulmonary vein isolation, group 2: Patients will undergo pulmonary vein isolation and renal artery denervation.
Conditions
- Paroxysmal Atrial Fibrillation
- Persistent Atrial Fibrillation
- Out of Range Hypertension
- Signs of Sympathetic Overdrive
Interventions
- PROCEDURE
-
procedure
Renal ablation+pulmonary vein isolation OR pulmonary vein isolation only
Sponsors & Collaborators
-
Diagram B.V.
lead OTHER
Principal Investigators
-
Arif Elvan, MD, PhD · Maatschap Cardiologie Isala
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-03-18
- Primary Completion
- 2022-01-19
- Completion
- 2022-01-19
Countries
- Netherlands
- Spain
Study Locations
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