Ganglionated Plexi Ablation vs Renal Denervation in Patients Undergoing Pulmonary Vein Isolation
1 other identifier
interventional
80
1 country
1
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 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 atrial-fibrillation
Started Jun 2012
Shorter than P25 for phase_2 atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 4, 2013
CompletedFirst Posted
Study publicly available on registry
July 15, 2013
CompletedJuly 15, 2013
July 1, 2013
1 year
July 4, 2013
July 12, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Freedom of AF or other atrial arrhythmias
12 months
Study Arms (2)
PVI+renal denervation+OMT
ACTIVE COMPARATORPVI+GP ablation+OMT
ACTIVE COMPARATORInterventions
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.
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).
Antiarrhythmic and antihypertensive therapy will be administered according to the guidelines
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
State Research Institute of Circulation Pathology
Novosibirsk, 630055, Russia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2013
First Posted
July 15, 2013
Study Start
June 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
July 15, 2013
Record last verified: 2013-07