Combined Treatment of Arterial Hypertension and Atrial Fibrillation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier:
NCT01897545
First received: July 3, 2013
Last updated: October 8, 2013
Last verified: October 2013

July 3, 2013
October 8, 2013
April 2012
April 2013   (final data collection date for primary outcome measure)
recurrence of > 30 secs of atrial tachyarrhythmia, including AF and left atrial flutter/tachycardia, after a single ablation procedure on no antiarrhythmic drug [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Freedom of AF or other atrial arrhythmias [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01897545 on ClinicalTrials.gov Archive Site
  • office blood pressure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • safety data before and at 3, 6, 9, and 12 months after procedure [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Systolic blood pressure lowering [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Combined Treatment of Arterial Hypertension and Atrial Fibrillation
The Role of Renal Denervation in Improving Outcomes of Catheter Ablation in Patients With Atrial Fibrillation and Arterial 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/non-resistant hypertension, undergoing AF ablation alone or combined with percutaneous renal denervation.

On the basis of the eligibility criteria, patients is assigned by the enrolling physician to one of two strata. The first stratum includes patients with moderate drug-resistant hypertension, defined by the Joint National Committee VII and ESH/ESC guidelines as office BP ≥ 140/90 mm Hg and <160/100 mm Hg. The second stratum includes patients with drug-resistant hypertension, defined by office BP ≥ 160/100 mm Hg.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Arterial Hypertension
  • 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: PV isolation+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: PV isolation
    Intervention: Procedure: Circumferential PV isolation
  • Active Comparator: PV isolation+renal denervation
    Intervention: Procedure: PV isolation+renal denervation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2013
April 2013   (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 ≥140/90 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:

  • Secondary causes of hypertension
  • Severe renal artery stenosis or dual renal arteries
  • Congestive heart failure with NYHA II-IV symptoms
  • Left ventricular ejection fraction <35%
  • Transverse left atrial diameter > 60 mm on transthoracic echocardiography

    1. Previous AF ablation procedure
    2. Treatment with amiodarone
  • Previous renal artery stenting or angioplasty
  • Type 1 diabetes mellitus
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Greece,   Russian Federation
 
NCT01897545
RDAFA-030
Yes
Meshalkin Research Institute of Pathology of Circulation
Meshalkin Research Institute of Pathology of Circulation
Not Provided
Not Provided
Meshalkin Research Institute of Pathology of Circulation
October 2013

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