Combined Treatment of Arterial Hypertension and Atrial Fibrillation

PHASE2CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

April 30, 2013

Study Completion Date

June 30, 2013

Conditions
Arterial HypertensionAtrial Fibrillation
Interventions
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.

PROCEDURE

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."

Trial Locations (3)

11528

Athens Euroclinic, Athens

630055

State Research Institute of Circulation Pathology, Novosibirsk

Unknown

The Valley Health System, New York

All Listed Sponsors
lead

Meshalkin Research Institute of Pathology of Circulation

NETWORK

NCT01897545 - Combined Treatment of Arterial Hypertension and Atrial Fibrillation | Biotech Hunter | Biotech Hunter