An interventional study of Catheter ablation and Mini-maze surgical procedure in Persistent Atrial Fibrillation, sponsored by The University of Texas Health Science Center, Houston. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-26.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment
This study will assess the efficacy of catheter ablation versus the Wolf Mini-Maze surgical ablation for rhythm control in patients with persistent afib.
Higher success rates have been achieved after a single surgical ablation when compared to catheter ablation, however contiguous and transmural lesions are not always guaranteed.
Even though, catheter ablation is now being offered for symptomatic persistent AF, recurrence after the index procedure in such a persistent AF substrate is not unusual. Redo-catheter ablation is routinely offered for such patients; however long term success still remains low. Non-pulmonary vein triggers are often targeted in such redo-catheter ablation procedures; though this approach remains controversial. More recently, the Wolf Mini-Maze procedure has been utilized with promising results.
This study proposes to randomize a group of persistent AF patients to undergo either catheter ablation or the surgical mini-maze procedure with left atrial appendage (LAA) ligation
Exclusion Criteria:
Catheter based radiofrequency ablation with wide antral circumferential PVI and isolation of posterior wall will be performed. Mitral and cavo-tricuspid isthmus ablation will be done only if such isthumus dependent flutters are documented prior to / during the procedure.
Procedure: Catheter ablation
Wolf Mini-maze surgical ablation along with left atrial appendage ligation will be performed.
Procedure: Mini-maze surgical procedure
Catheter based radiofrequency ablation with wide antral circumferential PVI and isolation of posterior wall will be performed. Mitral and cavo-tricuspid isthmus ablation will be done only if such isthumus dependent flutters are documented prior to / during the procedure.
Wolf Mini-maze surgical ablation along with left atrial appendage ligation will be performed.
Number of participants who are free from atrial fibrillation (AF)
Time frame: 12 months after the procedure
Number of participants who experienced a procedural complication
Time frame: 2 weeks after the procedure
Number of participants who are at risk of stroke
Time frame: 12 months after the procedure
Number of participants who were hospitalized for cardiovascular events
Time frame: 12 months after the procedure
AF burden as assessed by the CCA-SAF
AF burden will be assessed using the Canadian Cardiovascular Society - Severity of Atrial Fibrillation Score (CCA-SAF), which provides objective symptoms severity scoring.
Time frame: 12 months after the procedure
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center, Houston