Combined Treatment of Resistant Hypertension and Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01117025
• Other study ID #: RDAFA-029
• Secondary ID: RU MC 001
• Status: Completed
• Phase: Phase 2
• First received: April 30, 2010
• Last updated: July 8, 2013
• Start date: April 2010
• Est. completion date: April 2012

Study information

• Verified date: July 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 hypertension, undergoing AF ablation alone or combined with percutaneous renal denervation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 2012
• Est. primary completion date: August 2011
• 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 =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

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

• Atrial Fibrillation
• Coronary Vasospasm
• Hypertension
• Hypertension, Resistant to Conventional Therapy

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.
• 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.

Locations

Country	Name	City	State
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,  Russian Federation, 

References & Publications (1)

Pokushalov E, Romanov A, Corbucci G, Artyomenko S, Baranova V, Turov A, Shirokova N, Karaskov A, Mittal S, Steinberg JS. A randomized comparison of pulmonary vein isolation with versus without concomitant renal artery denervation in patients with refracto — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom of AF or other atrial arrhythmias		1 year	No
Secondary	Systolic blood pressure lowering		1 year	No

External Links

•   State Research Institute of Circulation Pathology Official Site