An interventional study of PVI and LA linear ablation in Atrial Fibrillation, sponsored by Shanghai Chest Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-10-20.
Sponsored by Shanghai Chest Hospital · Not applicable, Interventional, and Treatment
This randomized prospective study compared three ablation strategies in patients with longstanding persistent atrial fibrillation (LPeAF). It also explored the best procedural endpoint from among the following: circumferential pulmonary vein isolation (PVI)+left atrial (LA) linear lesions (roof line, mitral isthmus)+complex fractionated atrial electrogram (CFAE) ablation, PVI+LA linear lesions +cavotricuspid isthmus (CTI) ablation +CFAE ablation, and PVI+CFAE ablation.
Patients were randomized into three ablation groups: group A (n=100): PVI+LA linear ablation (roof line and mitral isthmus) +CFAE ablation; group B (n=100): PVI+linear ablation (roof line, mitral isthmus, and CTI) +CFAE ablation; group C (n=100), PVI+CFAE ablation.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 450 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Shanghai Chest Hospital is the lead sponsor of 194 studies on the registry; 94 are open to participants now.
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Exclusion Criteria:
The ablation procedure for atrial fibrillation guided by CARTO system, including PVI, LA linear ablation (roof line and mitral isthmus)and CFAE ablation.
Procedure: PVI · Procedure: LA linear ablation · Procedure: CFAE ablation · Device: CARTO
The ablation procedure for atrial fibrillation guided by CARTO system, including PVI,roof line and mitral isthmus,cavotricuspid isthmus abaltion and CFAE ablation.
Procedure: PVI · Procedure: LA linear ablation · Procedure: CFAE ablation · Procedure: linear ablation · Device: CARTO
The ablation procedure for atrial fibrillation guided by CARTO system, including PVI and CFAE ablation.
Procedure: PVI · Procedure: CFAE ablation · Device: CARTO
PVI was the complete isolation of all PVs, which was confirmed by entrance and/or exit block into or from the PV antra.
LA linear ablation include mitral isthmus ablation and roof line ablation. Mitral isthmus ablation (from the mitral annulus to the left inferior PV) was performed first, followed by roof line ablation (between the right and left superior PVs).
Ablation catheter was maintained in a stable position when the electrograms were being recorded for at least 5 s to avoid artifacts.The procedural endpoint of CFAEs was the complete elimination of fragmented atrial activity in local electrograms.
Right atrial CTI ablation was performed during SR.
3 dimensional mapping system
Time to first documented recurrence of atrial arrhythmias
Time to first documented recurrence of atrial arrhythmias after the first ablation procedure and after the final ablation procedure
Time frame: 2-year follow-up
Procedure duration at ablation
Minutes elapsed from the first puncture of the femoral vein to the removal of the last catheter
Time frame: At the end of the first ablation procedure
Ablation time at ablation
Minutes elapsed from the onset of the first energy delivery to the end of the last energy delivery
Time frame: At the end of the first ablation procedure ]
Fluoroscopy time at ablation
Minutes of fluoroscopy used during the entire ablation procedure
Time frame: At the end of the first ablation procedure
Complications
Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, and death.
Time frame: 2-year follow-up
Type of recurrent arrhythmia
Specific type of recurrent atrial arrhythmia
Time frame: 2-year follow-up
Number of redo procedures
Number of redo procedures，including two or more procedures
Time frame: 2-year follow-up
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Shanghai Chest Hospital