Persistent Atrial FibrillationNCT04509180
Comparison of Treatment Outcomes Between Convergent Procedure and Catheter Ablation for Persistent and Longstanding Persistent Atrial Fibrillation
A study testing Catheter ablation and Convergent procedure in people with Persistent Atrial Fibrillation and Longstanding Persistent Atrial Fibrillation, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
In the last 20 years, atrial fibrillation has become one of the leading healthcare burden in Europe and other developed countries. With an ever-increasing prevalence and incidence, atrial fibrillation is expected to remain a significant problem in the near future. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
- What is being tested?
- Catheter ablation and Convergent procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSlovenia
- Study dates
- 26 Feb 2021to 1 Sep 2024
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed persistent and/or long-term
- Failed medical therapy with antiarrhythmic drug therapy
Who cannot join
- Expected life expectancy of less than one year
- Previous heart operation
- Previous ablation procedure
- Left ventricular ejection fraction below 30 %
- Severe valvular heart disease
- Acute coronary syndrome
- Diminished functional capacity due to non-cardiac co-morbidities
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
In the last 20 years, atrial fibrillation has become one of the leading healthcare burden in Europe and other developed countries. With an ever-increasing prevalence and incidence, atrial fibrillation is expected to remain a significant problem in the near future. Due to numerous detrimental effects atrial fibrillation has on the patient's health, having an efficient and safe treatment is crucial for managing the problem.
The gold standard for an atrial fibrillation treatment is a catheter ablation. In typical catheter ablation procedure, triggers in pulmonary veins are addressed with a pulmonary vein isolation- offering a high long-term success rate in patients with paroxysmal atrial fibrillation. However, the same cannot be said for persistent and longstanding persistent atrial fibrillation. Studies have shown that efficiency of catheter ablation for persistent and longstanding persistent atrial fibrillation, including multiple procedures per patient, ranges around 50 %. It is postulated that extrapulmonary vein triggers, such as foci located in the posterior wall of the left atrium, play an important role in initiating and maintaining persistent and longstanding persistent atrial fibrillation. In the past, to address this issue, a convergent procedure was developed. In convergent procedure an epicardial ablation of posterior wall is performed through a subxyphoid window. Next, an endocardial ablation with an ablation catheter is performed to isolate pulmonary veins. Because the epicardial lesions are applied in the opposite direction and not towards the esophagus, ablation of posterior wall can safely be performed. The procedure offers a high long-term success rate (85%) in patients with persistent and longstanding persistent atrial fibrillation. However, due to higher associated invasiveness, the convergent procedure carries a higher risk of complications compared with catheter ablation (4 % vs 9 %).
Read more
With advancements in ablation catheter technology, such as continuous force measurement at the tip of the catheter, the depth and volume of the lesion can be estimated. This information greatly increases the reliability of lesion formation. The operator can thus effectively apply lesions to the posterior wall of the left atrium more safely in regards to the collateral damage to the esophagus.
The objectives of the study are:
- To compare procedural, safety and efficiency profile of convergent procedure with catheter ablation procedure, both targeting pulmonary veins triggers and triggers located in the posterior wall of the left atrium.
- To compare long-term success rate of convergent procedure with catheter ablation procedure, both targeting pulmonary veins triggers and triggers located in the posterior wall of the left atrium.
- Being tested
- Catheter ablation, Convergent 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.
Catheter ablationProcedure or surgery
Endovascular approach
Convergent procedureProcedure or surgery
Surgical and endovascular approach
| Study group | Role | What they receive |
|---|---|---|
| Catheter ablation group | Experimental | Patients undergoing catheter procedure will be put under conscious sedation and local anesthesia. Pulmonary vein isolation and posterior wall isolation will be performed with a radiofrequency ablation catheter (20-45W, open-tip irrigation). Ablation index will be used for the lesion formation guidance (450-500 on anterior aspects; 350-400 on the posterior aspects). A wide antral circumferential ablation will be performed for pulmonary veins and a box lesion set for the posterior left atrial wall. Voltage mapping and signal analysis performed by the operator will be used to assess electrical isolation of the pulmonary veins and posterior wall and to identify gaps in ablation lines. At the end of procedure, an implantable loop recorder will be inserted in the left parasternal region. Receives: Procedure: Catheter ablation |
| Convergent group | Active comparator | Patients undergoing convergent procedure will be put under general anesthesia. A minimally invasive epicardial radiofrequency ablation (30W, 90s) of posterior wall will be performed through a subxiphoid window. Monitoring of the esophageal temperature will be performed with an esophageal temperature probe set at 38°C. Next, an endocardial radiofrequency ablation (20-40W, open-tip irrigation; ablation index 450-500 anteriorly and 350-400 posteriorly) of pulmonary veins in a wide antral circumferential fashion will be performed. Voltage mapping and signal analysis performed by the operator will be used to assess the electrical isolation of the pulmonary veins and posterior wall and to identify the gaps in ablation lines. At the end of procedure, an implantable loop recorder will be inserted in the left parasternal region. Receives: Procedure: Convergent procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Noninferiority of catheter ablation
arrhythmia-free survival registered with an implantable loop recorder
Measured: 1 year
Secondary outcomes (3)
Differences in AF burden
registered with an implantable loop recorder
Measured: 1 year
Differences in acute success rate of posterior wall isolation
registered with voltage and activation mapping during the index procedure
Measured: 1 month
Differences in complication rate
procedure related complications
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start26 Feb 2021
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2024 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matevz Jan, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509180
- Sponsor's protocol ID
- 0120-161/2020/4
- Status last verified
- Jan 2023
- First submitted
- 7 Aug 2020
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Treatment Outcomes Between Convergent Procedure and Catheter Ablation for Persistent and Longstanding Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04509180
- Acronym / sponsor ID
- 0120-161/2020/4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 11 Aug 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.
In the last 20 years, atrial fibrillation has become one of the leading healthcare burden in Europe and other developed countries. With an ever-increasing prevalence and incidence, atrial fibrillation is expected to remain a significant problem in the near future. Due to numerous detrimental effects atrial fibrillation has on the patient's health, having an efficient and safe treatment is crucial for managing the problem.
The gold standard for an atrial fibrillation treatment is a catheter ablation. In typical catheter ablation procedure, triggers in pulmonary veins are addressed with a pulmonary vein isolation- offering a high long-term success rate in patients with paroxysmal atrial fibrillation. However, the same cannot be said for persistent and longstanding persistent atrial fibrillation. Studies have shown that efficiency of catheter ablation for persistent and longstanding persistent atrial fibrillation, including multiple procedures per patient, ranges around 50 %. It is postulated that extrapulmonary vein triggers, such as foci located in the posterior wall of the left atrium, play an important role in initiating and maintaining persistent and longstanding persistent atrial fibrillation. In the past, to address this issue, a convergent procedure was developed. In convergent procedure an epicardial ablation of posterior wall is performed through a subxyphoid window. Next, an endocardial ablation with an ablation catheter is performed to isolate pulmonary veins. Because the epicardial lesions are applied in the opposite direction and not towards the esophagus, ablation of posterior wall can safely be performed. The procedure offers a high long-term success rate (85%) in patients with persistent and longstanding persistent atrial fibrillation. However, due to higher associated invasiveness, the convergent procedure carries a higher risk of complications compared with catheter ablation (4 % vs 9 %).
With advancements in ablation catheter technology, such as continuous force measurement at the tip of the catheter, the depth and volume of the lesion can be estimated. This information greatly increases the reliability of lesion formation. The operator can thus effectively apply lesions to the posterior wall of the left atrium more safely in regards to the collateral damage to the esophagus.
The objectives of the study are:
- To compare procedural, safety and efficiency profile of convergent procedure with catheter ablation procedure, both targeting pulmonary veins triggers and triggers located in the posterior wall of the left atrium.
- To compare long-term success rate of convergent procedure with catheter ablation procedure, both targeting pulmonary veins triggers and triggers located in the posterior wall of the left atrium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter ablation group | Experimental | Procedure: Catheter ablationPatients undergoing catheter procedure will be put under conscious sedation and local anesthesia. Pulmonary vein isolation and posterior wall isolation will be performed with a radiofrequency ablation catheter (20-45W, open-tip irrigation). Ablation index will be used for the lesion formation guidance (450-500 on anterior aspects; 350-400 on the posterior aspects). A wide antral circumferential ablation will be performed for pulmonary veins and a box lesion set for the posterior left atrial wall. Voltage mapping and signal analysis performed by the operator will be used to assess electrical isolation of the pulmonary veins and posterior wall and to identify gaps in ablation lines. At the end of procedure, an implantable loop recorder will be inserted in the left parasternal region. |
| Convergent group | Active comparator | Procedure: Convergent procedurePatients undergoing convergent procedure will be put under general anesthesia. A minimally invasive epicardial radiofrequency ablation (30W, 90s) of posterior wall will be performed through a subxiphoid window. Monitoring of the esophageal temperature will be performed with an esophageal temperature probe set at 38°C. Next, an endocardial radiofrequency ablation (20-40W, open-tip irrigation; ablation index 450-500 anteriorly and 350-400 posteriorly) of pulmonary veins in a wide antral circumferential fashion will be performed. Voltage mapping and signal analysis performed by the operator will be used to assess the electrical isolation of the pulmonary veins and posterior wall and to identify the gaps in ablation lines. At the end of procedure, an implantable loop recorder will be inserted in the left parasternal region. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed persistent and/or long-term
- Failed medical therapy with antiarrhythmic drug therapy
Key exclusion criteria (8 listed)
- Expected life expectancy of less than one year
- Previous heart operation
- Previous ablation procedure
- Left ventricular ejection fraction below 30 %
- Severe valvular heart disease
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 |
|---|---|---|
| Catheter ablationEndovascular approach | Procedure or surgery | Catheter ablation group |
| Convergent procedureSurgical and endovascular approach | Procedure or surgery | Convergent group |
Primary outcome
Noninferiority of catheter ablation
Time frame: 1 year
arrhythmia-free survival registered with an implantable loop recorder
3 secondary outcomes
Differences in AF burden
Time frame: 1 year
Differences in acute success rate of posterior wall isolation
Time frame: 1 month
Differences in complication rate
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter ablation and Convergent procedure in people with Persistent Atrial Fibrillation and Longstanding Persistent Atrial Fibrillation, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 2 inclusion and 8 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: withdrawn, as of the sponsor's last update on 18 Jan 2023. 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 Slovenia. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Noninferiority of catheter ablation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2023.