Additional Linear Ablation Beyond Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation
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|ClinicalTrials.gov Identifier: NCT02637453|
Recruitment Status : Unknown
Verified December 2015 by Yi-Gang Li, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Recruitment status was: Recruiting
First Posted : December 22, 2015
Last Update Posted : December 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|Paroxysmal Atrial Fibrillation||Procedure: CPVI Procedure: CPVI+ALA||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||390 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Additional Linear Ablation Perpendicular to the Pulmonary Vein Isolation Line Reduces the Recurrence Rate of Paroxysmal Atrial Fibrillation (ALA-PAF)|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||May 2019|
Only circumferential pulmonary vein isolation(CPVI) was performed for these patients.
patients with circumferential pulmonary vein isolation （CPVI）
Besides circumferential pulmonary vein isolation(CPVI), additional linear ablation(ALA) perpendicular to the pulmonary vein ostium was performed for these patients, ie. CPVI+ALA.
patients with circumferential pulmonary vein isolation（CPVI）and additional linear ablation perpendicular to the PV ostium （ALA）
- Recurrence rate of atrial fibrillation(Af) in 12-month follow-up [ Time Frame: monthly up to 12 months ]
- The proportion of the observed time that a patient is in AF [ Time Frame: 12 months after ablation procedure ]The proportion of the observed time that a patient is in AF, when the fourteen days Holter is performed at the end of follow-up.
- Incidence of pulmonary vein stenosis, cardiac tamponade, phrenic nerve and embolism [ Time Frame: monthly up to 12 months ]
- Improvement of life quality (SF-36 questionnaire) [ Time Frame: monthly up to 12 months ]
- Major cardiovascular events: heart failure, stroke, hospitalization and cardiovascular death [ Time Frame: monthly up to 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02637453
|Contact: Yi-Gang Li, MD.||email@example.com|
|Contact: Jian Sun, MD.||firstname.lastname@example.org|
|Xinhua Hospital, Shanghai Jiao Tong University School of Medicne||Recruiting|
|Shanghai, Shanghai, China, 200092|
|Contact: Yi-Gang Li, MD. 13761318166 email@example.com|
|Contact: Jian Sun, MD. 15801816064 firstname.lastname@example.org|
|Principal Investigator: Yi-Gang Li, MD|
|Principal Investigator:||Yi-Gang Li, MD.||Department of Cardiology, Xinhua Hospital, Shanghai Jiaotong University School of Medicne|