Clinical Trials Logo
  1. Home
  2. Atrial Fibrillation
  3. NCT02562391
  4. Details
NCT02562391 Clinical Trial

Effect of Left Atrial Appendage Excision on Procedure Outcome in Patients With Persistent and Long-standing Persistent Atrial Fibrillation Undergoing Surgical Ablation

Atrial Fibrillation Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02562391
Other study ID # 9872TLAA
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received September 24, 2015
Last updated September 25, 2015
Start date May 2011
Est. completion date May 2017

Study information
Verified date September 2015
Source Meshalkin Research Institute of Pathology of Circulation
Contact n/a
Is FDA regulated No
Health authority Russia: Ethics Committee
Study type Interventional

Clinical Trial Summary

The aim of this study is to assess the effect of left atrial appendage excision on atrial fibrillation recurrence and incidence of stroke in patients with persistent and long-standing persistent atrial fibrillation undergoing surgical ablation.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 180
Est. completion date May 2017
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Key Inclusion Criteria:

- Patients with persistent and long-standing persistent atrial fibrillation eligible for thoracoscopy surgical ablation

- Signed inform consent

Key Exclusion Criteria:

- Paroxysmal atrial fibrillation

- Contraindications for surgical ablation

- Unwilling to participate

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Surgical ablation of the left atrium (PVI+Box lesions)

• Surgical ablation of the left atrium (PVI+Box lesions) and left atrial appendage cutting

Locations
Country Name City State
Russian Federation Federal Center of Cardiovascular surgery Krasnoyarsk
Russian Federation Federal State Institution Clinical Hospital of the Presidental Administration of the RF Moscow
Russian Federation Scientific center of the cardiovascular surgery named by A.N. Bakulev Moscow
Russian Federation State Research Institute of CIrculation Pathology Novosibirsk

Sponsors (1)
Lead Sponsor Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Atrial fibrillation recurrences 18 months Yes
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Completed NCT04571385 - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF) Phase 2
Terminated NCT04115735 - His Bundle Recording From Subclavian Vein
Completed NCT05366803 - Women's Health Initiative Silent Atrial Fibrillation Recording Study N/A
Completed NCT02864758 - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Recruiting NCT05442203 - Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease N/A
Completed NCT05599308 - Evaluation of Blood Pressure Monitor With AFib Screening Feature N/A
Completed NCT03790917 - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Enrolling by invitation NCT05890274 - Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO N/A
Recruiting NCT05316870 - Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation N/A
Recruiting NCT05266144 - Atrial Fibrillation Patients Treated With Catheter Ablation
Not yet recruiting NCT06023784 - The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Recruiting NCT04092985 - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed NCT04087122 - Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures N/A
Completed NCT06283654 - Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed NCT04546763 - Study Watch AF Detection At Home
Completed NCT03761394 - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke N/A