Atrial Fibrillation, PersistentTACAAFNCT04237389
Thoracoscopic Ablation Versus Catheter Ablation in Patients With Atrial Fibrillation
A study testing Ablation Index Guided endocardial catheter radiofrequency ablation and minimally invasive thoracoscopic surgical epicardial ablation. in people with Atrial Fibrillation, Persistent, run by National Research Center of Surgery, Russia at 1 site in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Persistent
- What is being tested?
- Ablation Index Guided endocardial catheter radiofrequency ablation and minimally invasive thoracoscopic surgical epicardial ablation.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 22 Mar 2019to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient is younger than 18 years old
- Contraindications for catheter or thoracoscopic ablation
- Any previous heart surgeries (open/interventional)
- Congenital heart diseases
- Paroxismal AF
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
A.V. Vishnevsky National Medical Research Center of Surgery
Moscow, 11799
Yulia Stepanova, +7(916)654-84-85, stepanovaua@mail.ru
Amiran Sh Revishvili, Academician
About this study
Official 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.
Read more
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.
Read the detailed description
The aim of this study is to compare 2 approaches for AF treatment, endocardial catheter isolation of the pulmonary veins (PV) versus minimally invasive thoracoscopic surgical epicardial ablation.
The patients in both groups will be comparable and have persistant or LSP AF only. Patients with previous catheter ablations or any interventions or open heart procedures in the anamnesis will be excluded. The catheter ablation will be Ablation Index-guided, which means that every ablation point will be taken according to ablation quality marker which corporates power, delivery time, contact force (CF), and catheter stability, called Ablation Index (AI). Both of the procedures will be performed by a single identical protocol including wide complete circumferential ablation around the right and left PVs, and additional lines between the lower and upper PVs. The thoracoscopic procedure will be supplemented with removal of left atrial appendage (LAA).
In cases of AF or other atrial tachycardia recurrence after both procedures, every patient will undergo the opposite procedure (for example, if patient after thoracoscopic ablation will be diagnosed an AF recurrence, he will undergo catheter ablation). That is why there will be the third group, the so-called Hybrid procedure group of patients.
- Conditions
- Atrial Fibrillation, Persistent
- Being tested
- Ablation Index Guided endocardial catheter radiofrequency ablation, minimally invasive thoracoscopic surgical epicardial ablation.
- Keywords
- persistent atrial fibrillation, catheter ablation, thoracoscopic ablation, LAA removal, Box-lesion, ablation index, high-density mapping, hybrid procedure
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation Index Guided endocardial catheter radiofrequency ablationProcedure or surgery
Ablation Index (AI) guided catheter RF ablation with circumferential ablation around the right and left PVs and 2 additional lines between the lower and upper PVs (endoBox-lesion).
minimally invasive thoracoscopic surgical epicardial ablation.Procedure or surgery
Description: minimally invasive thoracoscopic surgical epicardial ablation using "Box-lesion" set, which includes isolation of the right and left PVs, roof and posterior wall lines and removal of the LAA.
| Study group | Role | What they receive |
|---|---|---|
| Ablation Index guided catheter radiofrequency ablation | Active comparator | 30 patients, who undergo Ablation Index (AI) guided catheter RF ablation Receives: Procedure: Ablation Index Guided endocardial catheter radiofrequency ablation |
| Thoracoscopic surgical epicardial ablation | Active comparator | 30 patients, who undergo thoracoscopic ablation using "Box-lesion" set Receives: Procedure: minimally invasive thoracoscopic surgical epicardial ablation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 month
Major adverse cardiac and cerebral events (MACCE)
MACCE include death, stroke, transitory ischemic attack, hemopericarditis, implantation if pacemaker.
Measured: 12 month
Secondary outcomes (3)
Freedom of AAD
Freedom from any AAD and anticoagulation
Measured: 12 month
Postoperative hospitalization duration
The ammount of days after the procedure, wich were spent in the hospital
Measured: 2 month
Decrease in the frequency of AF episodes
Decrease of the ammount of AF episodes
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start22 Mar 2019
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation, PersistentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Center of Surgery, Russia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Revishvili Amiran Shotaevich, National Research Center of Surgery, Russia
- Investigators
- Elena A Artyukhina, Study chair, A.V. Vishnevsky National Medical Research Center of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237389
- Sponsor's protocol ID
- NRCSRussia02
- Acronym
- TACAAF
- Status last verified
- Jan 2020
- First submitted
- 15 Jan 2020
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Castella M, Kotecha D, van Laar C, Wintgens L, Castillo Y, Kelder J, Aragon D, Nunez 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 randomized trial. Europace. 2019 May 1;21(5):746-753. doi: 10.1093/europace/euy325.
PubMed 30715255
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Assessment of Catheter and Thoracoscopic Approaches in Patients With Persistent and Long-standing Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04237389
- Acronym / sponsor ID
- TACAAF / NRCSRussia02
- Conditions
- Atrial Fibrillation, Persistent
- Keywords
- persistent atrial fibrillation, catheter ablation, thoracoscopic ablation, LAA removal, Box-lesion, ablation index, high-density mapping, hybrid procedure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Research Center of Surgery, RussiaOther government
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of this study is to compare 2 approaches for AF treatment, endocardial catheter isolation of the pulmonary veins (PV) versus minimally invasive thoracoscopic surgical epicardial ablation.
The patients in both groups will be comparable and have persistant or LSP AF only. Patients with previous catheter ablations or any interventions or open heart procedures in the anamnesis will be excluded. The catheter ablation will be Ablation Index-guided, which means that every ablation point will be taken according to ablation quality marker which corporates power, delivery time, contact force (CF), and catheter stability, called Ablation Index (AI). Both of the procedures will be performed by a single identical protocol including wide complete circumferential ablation around the right and left PVs, and additional lines between the lower and upper PVs. The thoracoscopic procedure will be supplemented with removal of left atrial appendage (LAA).
In cases of AF or other atrial tachycardia recurrence after both procedures, every patient will undergo the opposite procedure (for example, if patient after thoracoscopic ablation will be diagnosed an AF recurrence, he will undergo catheter ablation). That is why there will be the third group, the so-called Hybrid procedure group of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ablation Index guided catheter radiofrequency ablation | Active comparator | Procedure: Ablation Index Guided endocardial catheter radiofrequency ablation30 patients, who undergo Ablation Index (AI) guided catheter RF ablation |
| Thoracoscopic surgical epicardial ablation | Active comparator | Procedure: minimally invasive thoracoscopic surgical epicardial ablation.30 patients, who undergo thoracoscopic ablation using "Box-lesion" set |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- Patient is younger than 18 years old
- Contraindications for catheter or thoracoscopic ablation
- Any previous heart surgeries (open/interventional)
- Congenital heart diseases
- Paroxismal AF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ablation Index Guided endocardial catheter radiofrequency ablationAblation Index (AI) guided catheter RF ablation with circumferential ablation around the right and left PVs and 2 additional lines between the lower and upper PVs (endoBox-lesion). | Procedure or surgery | Ablation Index guided catheter radiofrequency ablation |
| minimally invasive thoracoscopic surgical epicardial ablation.Description: minimally invasive thoracoscopic surgical epicardial ablation using "Box-lesion" set, which includes isolation of the right and left PVs, roof and posterior wall lines and removal of the LAA. | Procedure or surgery | Thoracoscopic surgical epicardial ablation |
Primary outcome
Freedom from AF and other atrial tachycardia
Time frame: 12 month
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
Major adverse cardiac and cerebral events (MACCE)
Time frame: 12 month
MACCE include death, stroke, transitory ischemic attack, hemopericarditis, implantation if pacemaker.
3 secondary outcomes
Freedom of AAD
Time frame: 12 month
Postoperative hospitalization duration
Time frame: 2 month
Decrease in the frequency of AF episodes
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Results publication: PubMed 30715255Castella M, Kotecha D, van Laar C, Wintgens L, Castillo Y, Kelder J, Aragon D, Nunez 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 randomized trial. Europace. 2019 May 1;21(5):746-753. doi: 10.1093/europace/euy325.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena A Artyukhina study chair
A.V. Vishnevsky National Medical Research Center of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation Index Guided endocardial catheter radiofrequency ablation and minimally invasive thoracoscopic surgical epicardial ablation. in people with Atrial Fibrillation, Persistent, run by National Research Center of Surgery, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irina A Taymasova (+7(916)6028095, irina-tame@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from AF and other atrial tachycardia (time frame: 12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04237389, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.