Status:
COMPLETED
Ganglionated Plexi Ablation vs Renal Denervation in Patients Undergoing Pulmonary Vein Isolation
Lead Sponsor:
Meshalkin Research Institute of Pathology of Circulation
Conditions:
Atrial Fibrillation
Hypertension
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 plu...
Eligibility Criteria
Inclusion
- 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/1⋅73 m2, with modification of diet using a renal disease formula
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01898910
Start Date
June 1 2012
End Date
June 1 2013
Last Update
July 15 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
State Research Institute of Circulation Pathology
Novosibirsk, Russia, 630055