Combined Treatment of Resistant Hypertension and Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01117025
Recruitment Status : Completed
First Posted : May 5, 2010
Last Update Posted : July 10, 2013
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation

April 30, 2010
May 5, 2010
July 10, 2013
April 2010
August 2011   (Final data collection date for primary outcome measure)
Freedom of AF or other atrial arrhythmias [ Time Frame: 1 year ]
Systolic blood pressure lowering [ Time Frame: 2 years ]
Complete list of historical versions of study NCT01117025 on Archive Site
Systolic blood pressure lowering [ Time Frame: 1 year ]
Freedom of AF or other atrial arrhythmias [ Time Frame: 2 years ]
Not Provided
Not Provided
Combined Treatment of Resistant Hypertension and Atrial Fibrillation
The Role of Renal Denervation in Improving Outcomes of Catheter Ablation in Patients With Refractory Symptomatic Atrial Fibrillation and Resistant Hypertension
The purpose of this study is the comparative evaluation of systolic blood pressure (SBP) lowering, atrial fibrillation (AF) recurrence and clinical data in patients with paroxysmal/persistent AF and resistant hypertension, undergoing AF ablation alone or combined with percutaneous renal denervation.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
  • Hypertension, Resistant to Conventional Therapy
  • Atrial Fibrillation
  • Procedure: Circumferential PV isolation
    The left atrium (LA) and pulmonary veins (PVs) are explored through a transeptal approach. Real-time 3D LA maps are reconstructed by using a nonfluoroscopic navigation system. The ipsilateral left and right PVs are encircled in one lesion line by circumferential PV isolation. Radiofrequency energy is delivered at 43°C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and is reduced to 43°C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation speed of 17 mL/min. Each lesion is ablated continuously until the local potential amplitude decreased by >80% or RF energy deliveries exceeded 40 s. The endpoint of circumferential PV isolation is PV isolation. Additional ablation lines are created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the roof of the LA between the two superior PVs. After the end of the procedure the implantable loop recorder is implanted in the parasternal area of the chest.
  • Procedure: Circumferential PVI+renal denervation

    The procedure of AF ablation is the same like in the circumferential PV isolation.

    After AF ablation procedure, the angiogram of both renal arteries is performed via femoral access. After that the treatment catheter is introduced into each renal artery and is applied discrete, radiofrequency ablations lasting up to 2 min each and of 8 watts or less to obtain up to six ablations separated both longitudinally and rotationally within each renal artery. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm. After the procedure the control arterial angiogram should be done.

  • Active Comparator: Circumferential PVI
    Intervention: Procedure: Circumferential PV isolation
  • Active Comparator: Circumferential PVI+renal denervation
    Intervention: Procedure: Circumferential PVI+renal denervation

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2012
August 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Symptomatic drug-refractory AF (with history of failure of ≥2 class I or III antiarrhythmic drugs) in patients referred for catheter ablation of AF
  • PAF with ≥1 monthly episodes or PersAF in patients who had already undergone ≥3 electrical cardioversions. PAF was defined as episodes lasting less than 7 days with spontaneous termination. PersAF was defined as lasting more than 7 days before being terminated pharmacologically or by electrical cardioversion.
  • Office-based systolic blood pressure of ≥160 mm Hg, despite treatment with ≥3 antihypertensive drugs (including 1 diuretic)
  • A glomerular filtration rate ≥45 mL/min/1⋅73 m2, with modification of diet using a renal disease formula

Exclusion Criteria:

  • Previous atrial fibrillation ablation
  • Type 1 of diabetes mellitus
  • Structural heart disease
  • Secondary cause of atrial hypertension
  • Severe renal artery stenosis or renal arteries abnormalities
  • Previous operations on renal arteries
  • Pregnancy
  • Previous heart, kidney, liver, or lung transplantation
  • Unwillingness of participant
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Russian Federation,   United States
RU MC 001 ( Other Identifier: State Research Institute of Circulation Pathology )
Not Provided
Not Provided
Meshalkin Research Institute of Pathology of Circulation
Meshalkin Research Institute of Pathology of Circulation
Not Provided
Principal Investigator: Evgeny A Pokushalov, MD, PhD State Research Institute of Circulation Pathology
Meshalkin Research Institute of Pathology of Circulation
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP