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NCT Number: NCT01897545

Combined Treatment of Arterial Hypertension and Atrial Fibrillation

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.

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Key information

Conditions

Arterial Hypertension Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Hypertension Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Athens Euroclinic, Athens, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Previous AF ablation procedure
  • Treatment with amiodarone
  • Previous renal artery stenting or angioplasty
  • Type 1 diabetes mellitus

Treatment and study plan

Circumferential PV isolation

Procedure

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.

PV isolation+renal denervation

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. office blood pressure

    Time frame: 1 year

  2. safety data before and at 3, 6, 9, and 12 months after procedure

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study title

The Role of Renal Denervation in Improving Outcomes of Catheter Ablation in Patients With Atrial Fibrillation and Arterial Hypertension

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 12, 2013
Registry last updated
Oct 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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