Persistent and Long Lasting or Chronic Atrial FibrillationSUPAFERNCT06291506
SUbstrate Ablation in Persistent Atrial Fibrillation for Elimination of Recurrences (SUPAFER).
A study testing Radiofrequency ablation of heart atrial tissue. in people with Persistent and Long Lasting or Chronic Atrial Fibrillation and Atrial Fibrillation Ablation, run by Hospital Universitario La Paz at 1 site in Spain.
Trial summary
Antecedents: electrical isolation of pulmonary veins is the standard treatment for patients with atrial fibrillation. However, its efficacy is lower in persistent and chronic forms of this arrhythmia compared to paroxysmal atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent and Long Lasting or Chronic Atrial Fibrillation, Atrial Fibrillation Ablation, Linear Left Atrial Ablation
- What is being tested?
- Radiofrequency ablation of heart atrial tissue.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2023to 1 May 2026
- 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
- Persistent atrial fibrillation documented with electrocardiogram and defined as: persistent (continuous AF duration >1 week) or long-lasting persistent (continuous AF duración >1 year).
- One of the following additional criteria: 1)symptomatic AF, 2)recurrence despite antiarrhythmic drugs or after electrical cardioversion, 3)tachymiopathy, 4)heart failure, 5)antiarrhythmic drugs either not tolerated or rejected or considered inadequate by the patient or an electrophysiology specialist, 6)preference for ablation explicitly manifested by the patient.
- Age >=18 years and written informed consent.
Who cannot join
- AF with a reversible cause.
- Previous pulmonary veins isolation or left atrial linear ablation.
- Cardiac surgery, acute coronary syndrome, percutaneous coronary intervention o ischaemic stroke <1 month before ablation.
- Intracranial haemorrhage <3 months before ablation.
- Ablation contraindicated due to 1)absolute contraindication for oral anticoagulants, 2)persistent atrial thrombus, 3)pregnancy, 4)extreme fragility and 5)life expectancy <1 year.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
La Paz University Hospital - IdiPaz
Madrid
José Luis Merino, MD, +34 912071301, lapaz@arritmias.net
Sergio Castrejón Castrejón
About this study
Official title: : SUbstrate Ablation in Persistent Atrial Fibrillation for Elimination of Recurrences (SUPAFER): a Multicentre Randomized Clinical Trial to Assess Pulmonary Vein Isolation Alone or Combined With Linear Ablation.
Antecedents: electrical isolation of pulmonary veins is the standard treatment for patients with atrial fibrillation. However, its efficacy is lower in persistent and chronic forms of this arrhythmia compared to paroxysmal atrial fibrillation. Many complementary techniques have been proposed, that added to pulmonary veins isolation, may reduce the recurrence rate of atrial fibrillation. However, none of them has obtained consistent results. Linear ablation aims to parcellate and modify the left atrial substrate responsible for atrial fibrillation maintenance. Previous studies have offered contradictory results using linear ablation.
Methods: SUPAFER is a multicenter, 1:1 randomized clinical trial that compares the efficacy of pulmonary veins isolation alone vs pulmonary vein isolation plus an specific protocol of left atrial linear ablation. Contrary to previous studies, the specific SUPAFER linear ablation is systematic, homogeneous and target atrial areas that have not been systematically ablated in previous trials. The trial aims at demonstrating the superiority of the combined ablative approach during 1-year follow-up. Daily transtelephonic ECG samples a 30 days continuous ECG monitoring are used to maximize de detection of recurrences, even asymptomatic.
- Conditions
- Persistent and Long Lasting or Chronic Atrial Fibrillation, Atrial Fibrillation Ablation, Linear Left Atrial Ablation, Daily Transtelephonic Electrocardiogram
- Being tested
- Radiofrequency ablation of heart atrial tissue.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation of heart atrial tissue.Other
Ablation with radiofrequency, advances techniques: contact force-guided, improved tissue temperature sensors, automark algorithms.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary veins isolation plus linear left atrial ablation. | Experimental | Not described Receives: Other: Radiofrequency ablation of heart atrial tissue. |
| Pumonary veins isolation only. | Active comparator | Not described Receives: Other: Radiofrequency ablation of heart atrial tissue. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrences of sustained >30 secons atrial arrhythmias measured by daily ECG samples (Kardia Alivecor) and 30 days continuous Holter.
Atrial fibrillation, atrial tachycardia (atrial flutter).
Measured: through study completion, 1 year follow-up
Secondary outcomes (2)
Acute intraprocedure efficacy.
Rate of: AF termination to sinus rhythm, organization to atrial tachycardia and non inducibility of AF or atrial tachycardia.
Measured: during the ablation procedure and up to 2 months blanking perior
Complications.
Complications associated to the ablation procedure.
Measured: through study completion, 1year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 May 2023
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent and Long Lasting or Chronic Atrial FibrillationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sergio Castrejón-Castrejón, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291506
- Sponsor's protocol ID
- 6270
- Acronym
- SUPAFER
- Status last verified
- Feb 2024
- First submitted
- 8 Jan 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- : SUbstrate Ablation in Persistent Atrial Fibrillation for Elimination of Recurrences (SUPAFER): a Multicentre Randomized Clinical Trial to Assess Pulmonary Vein Isolation Alone or Combined With Linear Ablation.
- ClinicalTrials.gov ID
- NCT06291506
- Acronym / sponsor ID
- SUPAFER / 6270
- Conditions
- Persistent and Long Lasting or Chronic Atrial Fibrillation, Atrial Fibrillation Ablation, Linear Left Atrial Ablation, Daily Transtelephonic Electrocardiogram
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 4 Mar 2024 (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.
Antecedents: electrical isolation of pulmonary veins is the standard treatment for patients with atrial fibrillation. However, its efficacy is lower in persistent and chronic forms of this arrhythmia compared to paroxysmal atrial fibrillation. Many complementary techniques have been proposed, that added to pulmonary veins isolation, may reduce the recurrence rate of atrial fibrillation. However, none of them has obtained consistent results. Linear ablation aims to parcellate and modify the left atrial substrate responsible for atrial fibrillation maintenance. Previous studies have offered contradictory results using linear ablation.
Methods: SUPAFER is a multicenter, 1:1 randomized clinical trial that compares the efficacy of pulmonary veins isolation alone vs pulmonary vein isolation plus an specific protocol of left atrial linear ablation. Contrary to previous studies, the specific SUPAFER linear ablation is systematic, homogeneous and target atrial areas that have not been systematically ablated in previous trials. The trial aims at demonstrating the superiority of the combined ablative approach during 1-year follow-up. Daily transtelephonic ECG samples a 30 days continuous ECG monitoring are used to maximize de detection of recurrences, even asymptomatic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| Pulmonary veins isolation plus linear left atrial ablation. | Experimental | Other: Radiofrequency ablation of heart atrial tissue. |
| Pumonary veins isolation only. | Active comparator | Other: Radiofrequency ablation of heart atrial tissue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Persistent atrial fibrillation documented with electrocardiogram and defined as: persistent (continuous AF duration >1 week) or long-lasting persistent (continuous AF duración >1 year).
- One of the following additional criteria: 1)symptomatic AF, 2)recurrence despite antiarrhythmic drugs or after electrical cardioversion, 3)tachymiopathy, 4)heart failure, 5)antiarrhythmic drugs either not tolerated or rejected or considered inadequate by the patient or an electrophysiology specialist, 6)preference for ablation explicitly manifested by the patient.
- Age >=18 years and written informed consent.
Key exclusion criteria (5 listed)
- AF with a reversible cause.
- Previous pulmonary veins isolation or left atrial linear ablation.
- Cardiac surgery, acute coronary syndrome, percutaneous coronary intervention o ischaemic stroke <1 month before ablation.
- Intracranial haemorrhage <3 months before ablation.
- Ablation contraindicated due to 1)absolute contraindication for oral anticoagulants, 2)persistent atrial thrombus, 3)pregnancy, 4)extreme fragility and 5)life expectancy <1 year.
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 |
|---|---|---|
| Radiofrequency ablation of heart atrial tissue.Ablation with radiofrequency, advances techniques: contact force-guided, improved tissue temperature sensors, automark algorithms. | Other | Pulmonary veins isolation plus linear left atrial ablation., Pumonary veins isolation only. |
Primary outcome
Recurrences of sustained >30 secons atrial arrhythmias measured by daily ECG samples (Kardia Alivecor) and 30 days continuous Holter.
Time frame: through study completion, 1 year follow-up
Atrial fibrillation, atrial tachycardia (atrial flutter).
2 secondary outcomes
Acute intraprocedure efficacy.
Time frame: during the ablation procedure and up to 2 months blanking perior
Complications.
Time frame: through study completion, 1year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation of heart atrial tissue. in people with Persistent and Long Lasting or Chronic Atrial Fibrillation and Atrial Fibrillation Ablation, run by Hospital Universitario La Paz at 1 site in Spain.
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 3 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 4 Mar 2024. 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 Spain. 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 José Luis Merino Llorens, MD, PhD (+34 912071301 ext. 441301, lapaz@arritmias.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrences of sustained >30 secons atrial arrhythmias measured by daily ECG samples (Kardia Alivecor) and 30 days continuous Holter. (time frame: through study completion, 1 year follow-up). 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 4 Mar 2024.