Combined Treatment of Resistant Hypertension and Atrial Fibrillation

Sponsor

Meshalkin Research Institute of Pathology of Circulation (Other)

Overall Status

Completed

CT.gov ID

NCT01117025

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension, Resistant to Conventional Therapy Atrial Fibrillation	Procedure: Circumferential PV isolation Procedure: Circumferential PVI+renal denervation	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Circumferential PVI	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.
Active Comparator: Circumferential PVI+renal denervation	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.

Arm

Intervention/Treatment

Active Comparator: Circumferential PVI

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.

Active Comparator: Circumferential PVI+renal denervation

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.

Outcome Measures

Primary Outcome Measures

Freedom of AF or other atrial arrhythmias [1 year]

Secondary Outcome Measures

Systolic blood pressure lowering [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Valley Health System	New York	New York	United States
2	State Research Institute of Circulation Pathology	Novosibirsk		Russian Federation	630055

Sponsors and Collaborators

Meshalkin Research Institute of Pathology of Circulation

Investigators

Principal Investigator: Evgeny A Pokushalov, MD, PhD, State Research Institute of Circulation Pathology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Meshalkin Research Institute of Pathology of Circulation

ClinicalTrials.gov Identifier:

NCT01117025

Other Study ID Numbers:

RDAFA-029
RU MC 001

First Posted:

May 5, 2010

Last Update Posted:

Jul 10, 2013

Last Verified:

Jul 1, 2013

Keywords provided by Meshalkin Research Institute of Pathology of Circulation

Resistant hypertension

Atrial Fibrillation

Percutaneous renal denervation

Additional relevant MeSH terms:

Hypertension

Atrial Fibrillation

Study Results

No Results Posted as of Jul 10, 2013