Combined Treatment of Arterial Hypertension and Atrial Fibrillation

NCT01897545 | Completed Phase 2 DMC

• 1 other identifier: RDAFA-030
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 3

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/non-resistant hypertension, undergoing AF ablation alone or combined with percutaneous renal denervation.

Conditions

Arterial Hypertension; Atrial Fibrillation

Keywords

Arterial hypertension; Atrial Fibrillation; Percutaneous renal denervation

Outcome Measures

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

  1 year

Secondary Outcomes (2)

• office blood pressure

  1 year

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

  1 year

Study Arms (2)

PV isolation

ACTIVE COMPARATOR

Procedure: Circumferential PV isolation

PV isolation+renal denervation

ACTIVE COMPARATOR

Procedure: PV isolation+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.

PV isolation

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.

PV isolation+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 ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (3)

The Valley Health System

New York, New York, United States

Location

Athens Euroclinic

Athens, 11528, Greece

Location

State Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

Location

Related Publications (1)

• 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; Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

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: July 3, 2013
• First Posted: July 12, 2013
• Study Start: April 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 9, 2013

Record last verified: 2013-10

Locations

US (1); GR (1); RU (1)