Combined Treatment of Arterial Hypertension and Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01897545
• Other study ID #: RDAFA-030
• Status: Completed
• Phase: Phase 2
• First received: July 3, 2013
• Last updated: October 8, 2013
• Start date: April 2012
• Est. completion date: June 2013

Study information

• Verified date: October 2013
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Hypertension
• Atrial Fibrillation
• Hypertension

Intervention

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.
• 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.

Locations

Country	Name	City	State
Greece	Athens Euroclinic	Athens
Russian Federation	State Research Institute of Circulation Pathology	Novosibirsk
United States	The Valley Health System	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Countries where clinical trial is conducted

United States,  Greece,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence of > 30 secs of atrial tachyarrhythmia, including AF and left atrial flutter/tachycardia, after a single ablation procedure on no antiarrhythmic drug		1 year	No
Secondary	office blood pressure		1 year	No
Secondary	safety data before and at 3, 6, 9, and 12 months after procedure		1 year	Yes