Treatment of Atrial Fibrillation in Patients by Pulmonary Vein Isolation in Combination With Renal Denervation or Pulmonary Vein Isolation Only
Condition: Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation; Out of Range Hypertension; Signs of Sympathetic Overdrive
MeSH terms: Hypertension; Atrial Fibrillation
Study type: Interventional

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.
    

Detailed description: 
      The target group of patients are subjects ages <65 years, with paroxysmal or persistent
      atrial fibrillation, who have out of range hypertension (systolic >140 mmHg or >130/80 mmHg
      in diabetics and patients with chronic renal disease) or signs of sympathetic overdrive.
      Patients should use at least 2 anti-hypertensive's or should be intolerant for
      antihypertensive medication.

      Atrial fibrillation terminology: If atrial fibrillation recurs more than once but terminates
      spontaneously within seven days, the term paroxysmal AF is used. This is also used when the
      episode is less than 48 hours in duration and is terminated with electrical or
      pharmacological cardioversion. Persistent AF is defined as recurrent AF that is sustained for
      more than seven days. A patient that is electrically or pharmacologically cardioverted after
      more than two days is also diagnosed with persistent AF.

      After the exclusion of apparent secondary causes of hypertension, patients will be randomized
      to one of the following interventional treatments:

      First arm: PVI (69 patients) Second arm: PVI + RDN (69 patients)

      The patient will be treated under conscious sedation or general anesthesia. The control group
      will consist of patients who undergo PVI alone. The study will be a randomized, controlled
      trial. The follow up period will be up to one year after the interventional therapy. Patients
      will be treated clinically and will have regular follow-up at the outpatient clinic of the
      hospital at which they were treated. If patients receive continuous loop recorders for
      cardiac rhythm monitoring, this data will be used for the study. The other patients will
      undergo Holter ECG monitoring at regular intervals during follow-up (at 3, 6 and 12 months
      after the interventional treatment). During follow-up, the first 3 months after the
      interventional treatment will be a blanking period, as is common in the ablative therapy of
      AF (ablations points need to heal, and paroxysms of AF in this period are not associated with
      therapy failure).
    

Intervention name(s): procedure
Intervention type(s): Procedure
Intervention description(s): Renal ablation+pulmonary vein isolation OR pulmonary vein isolation only
Other intervention name(s): Renal ablation+pulmonary vein isolation OR pulmonary vein isolation only
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Paroxysmal atrial fibrillation; Persistent atrial fibrillation; Out of range hypertension; Signs of sympathetic overdrive