Combined Treatment of Resistant Hypertension and Atrial Fibrillation
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|ClinicalTrials.gov Identifier: NCT01117025|
Recruitment Status : Completed
First Posted : May 5, 2010
Last Update Posted : July 10, 2013
|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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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 :||April 2010|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||April 2012|
|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.
- Freedom of AF or other atrial arrhythmias [ Time Frame: 1 year ]
- Systolic blood pressure lowering [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01117025
|United States, New York|
|The Valley Health System|
|New York, New York, United States|
|State Research Institute of Circulation Pathology|
|Novosibirsk, Russian Federation, 630055|
|Principal Investigator:||Evgeny A Pokushalov, MD, PhD||State Research Institute of Circulation Pathology|