Combined Treatment of Resistant Hypertension and Atrial Fibrillation

NCT01117025 | Completed Phase 2 DMC

• 2 other identifiers: RDAFA-029RU MC 001
• Study Type: interventional
• Target: 26
• Locations: 2 countries
• Sites: 2

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.

Conditions

Hypertension, Resistant to Conventional Therapy; Atrial Fibrillation

Keywords

Resistant hypertension; Atrial Fibrillation; Percutaneous renal denervation

Outcome Measures

Primary Outcomes (1)

• Freedom of AF or other atrial arrhythmias

  1 year

Secondary Outcomes (1)

• Systolic blood pressure lowering

  1 year

Study Arms (2)

Circumferential PVI

ACTIVE COMPARATOR

Procedure: Circumferential PV isolation

Circumferential PVI+renal denervation

ACTIVE COMPARATOR

Procedure: Circumferential PVI+renal denervation

Interventions

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.

Circumferential PVI

Circumferential PVI+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.

Circumferential PVI+renal denervation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (2)

The Valley Health System

New York, New York, United States

Location

State Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

Location

Related Publications (2)

• 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 refractory symptomatic atrial fibrillation and resistant hypertension. J Am Coll Cardiol. 2012 Sep 25;60(13):1163-70. doi: 10.1016/j.jacc.2012.05.036. Epub 2012 Sep 5.

  PMID: 22958958 RESULT

• Pokushalov E, Romanov A, Katritsis DG, Artyomenko S, Bayramova S, Losik D, Baranova V, Karaskov A, Steinberg JS. Renal denervation for improving outcomes of catheter ablation in patients with atrial fibrillation and hypertension: early experience. Heart Rhythm. 2014 Jul;11(7):1131-8. doi: 10.1016/j.hrthm.2014.03.055. Epub 2014 Mar 29.

  PMID: 24691452 DERIVED

MeSH Terms

Conditions

Hypertension Resistant to Conventional Therapy; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Evgeny A Pokushalov, MD, PhD

  State Research Institute of Circulation Pathology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: May 5, 2010
• Study Start: April 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: April 1, 2012
• Last Updated: July 10, 2013

Record last verified: 2013-07

Locations

US (1); RU (1)