Ganglionated Plexi Ablation vs Renal Denervation in Patients Undergoing Pulmonary Vein Isolation

PHASE2CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

June 30, 2013

Study Completion Date

June 30, 2013

Conditions
Atrial FibrillationHypertension
Interventions
PROCEDURE

PVI+renal denervation

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.

PROCEDURE

PVI + GP ablation

To accomplish ganglionated plexi ablation, LA target sites were identified as the anatomic locations where vagal reflexes were evoked by transcatheter high-frequency stimulation (HFS). Rectangular electrical stimuli were delivered at a frequency of 20-50 Hz, output amplitude 15 V and pulse duration of 10 ms, for 5 sec (Stimulator B-53, Biotok Inc, Russia).

DRUG

Optimal medial therapy (OMT)

Antiarrhythmic and antihypertensive therapy will be administered according to the guidelines

Trial Locations (1)

630055

State Research Institute of Circulation Pathology, Novosibirsk

All Listed Sponsors
lead

Meshalkin Research Institute of Pathology of Circulation

NETWORK

NCT01898910 - Ganglionated Plexi Ablation vs Renal Denervation in Patients Undergoing Pulmonary Vein Isolation | Biotech Hunter | Biotech Hunter