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NCT01898910 Clinical Trial

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

Hypertension Clinical Trial

Official title:
Ganglionated Plexi Ablation vs Renal Denervation in Patients Undergoing Pulmonary Vein Isolation. A Randomized Comparison

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01898910
Other study ID # RDGP-031
Secondary ID
Status Completed
Phase Phase 2
First received July 4, 2013
Last updated July 12, 2013
Start date June 2012
Est. completion date June 2013

Study information
Verified date July 2013
Source Meshalkin Research Institute of Pathology of Circulation
Contact n/a
Is FDA regulated No
Health authority Russia: Ethics Committee
Study type Interventional

Clinical Trial Summary

The investigators have conducted a prospective, double-blind, randomized study to assess the comparative safety and efficacy of two different strategies, PVI plus Renal Denervation (RD) versus PVI plus GP ablation, in patients with atrial fibrillation. Results were assessed after follow-up of at least 1 year with the use of an implanted monitoring device (IMD).

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- 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.

- History of significant hypertension (defined as SBP = 160 mmHg and/or DBP = 100 mmHg), receiving treatment with at least one antihypertensive medication

- A glomerular filtration rate =45 mL/min/1ยท73 m2, with modification of diet using a renal disease formula

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.
• 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

Locations
Country Name City State
Russian Federation State Research Institute of Circulation Pathology Novosibirsk

Sponsors (1)
Lead Sponsor Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Freedom of AF or other atrial arrhythmias 12 months No
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