Atrial Fibrillation, Persistent Clinical Trial
— TACAAFOfficial title:
Comparative Assessment of Catheter and Thoracoscopic Approaches in Patients With Persistent and Long-standing Persistent Atrial Fibrillation
Despite good progress in the management of patients with atrial fibrillation (AF), this
arrhythmia remains one of the major causes of stroke, heart failure, sudden death, and
cardiovascular morbidity in the world. Furthermore, the number of patients with AF is
predicted to rise steply in the coming years.
Even if the amount of antiarrhythmic drugs (AAD) is constantly increasing, there is a group
of patients who has AF, resistant to AAD therapy. In such cases they are being offered
alternative minimally invasive procedures, such as catheter or thoracoscopic ablation. With
the discovery that AF often is initiated and maintained by electrical instability inside and
around the pulmonary veins (PV) catheter and thoracoscopic ablation are now widely accepted
invasive strategies to cure AF.
Even though the results of both of the procedures are very promising in treating patients
with paroxysmal AF, the decision making process, which approach should be used in patients
with persistant or LSPAF, is still very controversial.
According to 2016 ESC Guidelines for the management of atrial fibrillation developed in
collaboration with EACTS, catheter or surgical ablation should be considered in patients with
symptomatic persistent or long-standing persistent (LSP) AF refractory to AAD therapy to
improve symptoms, considering patient choice, benefit and risk, supported by an AF Heart Team
(IIaC).
Since, there is no actual evidence base, which approach is more effective and save in
patients with persistant and LSP AF, the aim of the investigator's study is to evaluate the
results of both of the approaches in such group of patients.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | August 31, 2022 |
Est. primary completion date | August 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patient is older than 18 years old - Patient has nonparoxismal atrial fibrillation - Sympthomatic AF - Patient is refractory to at least one antiarrhythmic drug - Indications for catheter or thoracoscopic ablation - Absence of previous failed catheter or surgical AF ablations - Patients agreement Exclusion Criteria: - Patient is younger than 18 years old - Contraindications for catheter or thoracoscopic ablation - Any previous heart surgeries (open/interventional) - Congenital heart diseases - Paroxismal AF |
Country | Name | City | State |
---|---|---|---|
Russian Federation | A.V. Vishnevsky National Medical Research Center of Surgery | Moscow |
Lead Sponsor | Collaborator |
---|---|
National Research Center of Surgery, Russia |
Russian Federation,
Castellá M, Kotecha D, van Laar C, Wintgens L, Castillo Y, Kelder J, Aragon D, Nuñez M, Sandoval E, Casellas A, Mont L, van Boven WJ, Boersma LVA, van Putte BP. Thoracoscopic vs. catheter ablation for atrial fibrillation: long-term follow-up of the FAST r — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Freedom from AF and other atrial tachycardia | Freedom from AF and other atrial tachycardias, lasting more than 60 sec, determined by 24-hour Holter monitoring. Other atrial tachycardias include left atrial flutters, typical atrial flutters |
12 month | |
Primary | Major adverse cardiac and cerebral events (MACCE) | MACCE include death, stroke, transitory ischemic attack, hemopericarditis, implantation if pacemaker. | 12 month | |
Secondary | Freedom of AAD | Freedom from any AAD and anticoagulation | 12 month | |
Secondary | Postoperative hospitalization duration | The ammount of days after the procedure, wich were spent in the hospital | 2 month | |
Secondary | Decrease in the frequency of AF episodes | Decrease of the ammount of AF episodes | 12 month |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04544397 -
Outcomes of Second Generation Laser Balloon Ablation for Atrial Fibrillation
|
||
Completed |
NCT04473963 -
FLOW-AF: A Study to Evaluate the Ablacon Electrographic FLOW EGF Technology
|
N/A | |
Recruiting |
NCT04715425 -
Thoracoscopic Surgical Versus Catheter Ablation Approaches for Primary Treatment of Persistent Atrial Fibrillation
|
N/A | |
Completed |
NCT04045067 -
Low-voltage Areas Defragmentation in Sinus Rhythm for Radiofrequency Ablation of Persistent Atrial Fibrillation
|
||
Enrolling by invitation |
NCT04148625 -
Subxyphoid Hybrid MAZE Registry for Patients With Persistent Atrial Fibrillation
|
||
Active, not recruiting |
NCT05481359 -
AF-FLOW Registry: This Study is to Evaluate Ablamap Software in Patients Undergoing Ablation for Atrial Fibrillation.
|
||
Completed |
NCT06260670 -
FLOW EVAL-AF: FLOW Mapping Electrogram VALidation in Patients With Persistent Atrial Fibrillation
|
N/A | |
Recruiting |
NCT05883631 -
RESOLVE-AF: Clinical Evaluation of the Ablacathâ„¢ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-PV Sources of Atrial Fibrillation and Guide Ablation Therapy.
|
N/A | |
Recruiting |
NCT04942834 -
Using Cryoballoon Ablation as Initial Treatment for Persistent Atrial Fibrillation
|
N/A | |
Recruiting |
NCT04606693 -
Value of Screening and Treatment of SAHS in the Management of AF Ablation Candidates
|
N/A | |
Enrolling by invitation |
NCT04508491 -
Cognitive Function in Patients With Persisted Atrial Fibrillation
|
N/A | |
Active, not recruiting |
NCT05507749 -
Cyroablation for Pulmonary Vein Isolation Alone in Patients With Early Persistent AF Assessed by Continuous Monitoring
|
N/A | |
Not yet recruiting |
NCT06098989 -
A Prospective Study of REPeat Ablation In Patients With Recurrent PERSistent Atrial Fibrillation: Pulmonary Vein Isolation vs. Adjunct Posterior Wall Isolation (REPAIR PERS-AF Study)
|
N/A | |
Recruiting |
NCT05575557 -
Pulmonary Artery Pressure and Right Heart Evaluation for Patients Requiring Physiological Pacing Treatment
|
N/A | |
Recruiting |
NCT05411614 -
Hybrid AbLaTion of Atrial Fibrillation
|
N/A | |
Recruiting |
NCT04342312 -
Intensive Molecular and Electropathological Characterization of Patients Undergoing Atrial Fibrillation Ablation
|
||
Recruiting |
NCT04542785 -
Lenient Rate Control Versus Strict Rate Control for Atrial Fibrillation. The Danish Atrial Fibrillation Randomised Clinical Trial
|
N/A | |
Terminated |
NCT04206917 -
MultiPulse Therapy (MPT) for AF
|
N/A | |
Recruiting |
NCT04229160 -
Noninvasive 3D Mapping in Persistent Atrial Fibrillation, to Describe Modifications of the Arrhythmogenic Substrate After Pulmonary Vein Isolation and Identify Potential Predicting Factors of Ablation Success
|
N/A | |
Not yet recruiting |
NCT05883722 -
Adjunctive Right Atrial Ablation for Persistent Atrial Fibrillation
|
N/A |