Paroxysmal AFSVC-RESCUE-AFNCT07112716
SVC-isolation in Redo-AF Ablation With Isolated PV
A study testing Empirical superior vena cava isolation and Ablation without empirical superior vena cava isolation in people with Paroxysmal AF, run by Centro Medico Teknon at 1 site in Spain.
Trial summary
Atrial fibrillation is the most common arrhythmia in the population and is often caused by arrhythmogenic foci located in the pulmonary veins. For this reason, the first attempt in atrial fibrillation catheter ablation procedures is to isolate these structures (the procedure is called indeed "pulmonary vein… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal AF
- What is being tested?
- Empirical superior vena cava isolation and Ablation without empirical superior vena cava isolation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2025to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age > 18 years.
- Confirmed diagnosis of recurrent paroxysmal AF
- Previous transcatheter PVI-only procedure for AF.
- Evidence of persistently isolated pulmonary veins at repeat procedure.
- Signed informed consent.
Who cannot join
- Age < 18 years.
- Pregnancy.
- Concomitant investigation treatments.
- Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.
- Lesions other than PVI performed during first procedure
- Persistent AF at recurrence.
- Evidence of pulmonary vein reconnection at repeat procedure.
- Any additional lesion performed beyond SVC isolation during repeat procedure (in the empirical SVC isolation group only).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Diego Penela, MD, PhD contact
Spain1 site
Heart Institute, Teknon Medical Centre
Barcelona, Barcelona, 08034
Antonio Berruezo, MD, PhD, 93 290 62 51 ext. + 34, antonio.berruezo@quironsalud.es
About this study
Official title: Superior Vena Cava Isolation With Radiofrequency Ablation in Patients With Recurrent Paroxysmal Atrial Fibrillation and Durably Isolated Pulmonary Veins: A Multicenter Study
Atrial fibrillation is the most common arrhythmia in the population and is often caused by arrhythmogenic foci located in the pulmonary veins. For this reason, the first attempt in atrial fibrillation catheter ablation procedures is to isolate these structures (the procedure is called indeed "pulmonary vein isolation"), which results in abolishment of arrhythmia recurrence in up to 85% of patients at short and mid-term follow-up. However, a subset of patients experience an atrial tachyarrhytmia recurrence and a second catheter ablation procedure has to be performed. If pulmary vein isolation is proven to be durable, other arrhythmogenic foci could be implicated in arrhythmia recurrence. Among extra-pulmonary vein foci, superior vena cava has been described as the most frequently involved in atrial fibrillation initiation. Therefore, its ablation could result in improved freedom from atrial fibrillation episodes during follow-up. In the present study, we sought to evaluate the safety and effectiveness of empirical superior vena cava isolation in terms of arrhythmia-free survival in patients with paroxysmal atrial fibrillation recurrence despite durable pulmonary vein isolation.
Read the detailed description
Atrial fibrillation (AF) is the most frequent arrhythmia in the general population (1), with an expected doubling in prevalence within 2060 (2). Since the late 1990s (3), pulmonary vein isolation (PVI) has become a cornerstone in drug refractory AF treatment, and more recently has emerged a first line therapy in paroxysmal AF patients (4) due to its proven superiority to antiarrhythmic drugs in achieving arrhythmia-free survival (5).
PVI is a safe and effective procedure in the vast majority of patients with paroxysmal AF, with high AF-free survival at mid- and long-term follow-up. In case of AF recurrence, repeat ablation of pulmonary vein reconnections demonstrated superior outcomes compared to the use of anti-arrhythmic drugs in both paroxysmal and persistent AF (6). Nevertheless, a subset of patients with AF recurrence results to be "PVI non-responder", with arrhythmia recurrence despite durable ablation results (7). How to manage these patients is still a matter of debate, with different additional lesion sets proposed so far (8).
Non-PVI triggers have been implicated in AF initiation, with superior vena cava (SVC) being the most common of them (9,10). Empirical SVC isolation has been attempted in some observational as well as randomized study (11-14), but definitive conclusion could not be drawn due to lack of statistical power as well as variable eligibility criteria (first vs repeat procedure, paroxysmal vs persistent AF) and ablation sets (15).
In the present study, we sought to evaluate the safety and effectiveness of empirical SVC isolation in terms of arrhythmia-free survival in patients with paroxysmal AF recurrence despite durable PVI.
- Conditions
- Paroxysmal AF
- Being tested
- Empirical superior vena cava isolation, Ablation without empirical superior vena cava isolation
- Keywords
- Atrial fibrillation, Paroxysmal, Recurrence, Superior Vena Cava Isolation
- Medical subject headings
- Atrial Fibrillation, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empirical superior vena cava isolationProcedure or surgery
Empirical superior vena cava isolation with radiofrequency ablation
Ablation without empirical superior vena cava isolationProcedure or surgery
No ablation or ablation of other arrhythmic foci wuthout empirical superior vena cava isolation
| Study group | Role | What they receive |
|---|---|---|
| SVC isolation group | Active comparator | Empirical superior vena cava isolation Receives: Procedure: Empirical superior vena cava isolation |
| Control arm | Sham comparator | No empirical superior vena cava isolation Receives: Procedure: Ablation without empirical superior vena cava isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arrhythmia-free survival
Occurence of any sustained atrial arrhythmia (AF, atrial flutter or any atrial tachycardia) lasting ≥ 30 s, after a 2-month blanking period
Measured: 12 months follow-up
Secondary outcomes (1)
Procedure-related complications
Any procedure complication
Measured: 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal AFStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Medico Teknon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Berruezo, MD, PhD, Centro Medico Teknon
- Investigators
- Antonio Berruezo, MD, PhD, Principal investigator, Teknon Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112716
- Sponsor's protocol ID
- SVC-RESCUE-AF
- Other IDs
- SVC-RESCUE-AF
- Acronym
- SVC-RESCUE-AF
- Status last verified
- Aug 2025
- First submitted
- 2 Aug 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superior Vena Cava Isolation With Radiofrequency Ablation in Patients With Recurrent Paroxysmal Atrial Fibrillation and Durably Isolated Pulmonary Veins: A Multicenter Study
- ClinicalTrials.gov ID
- NCT07112716
- Acronym / sponsor ID
- SVC-RESCUE-AF / SVC-RESCUE-AF
- Conditions
- Paroxysmal AF
- Keywords
- Atrial fibrillation, Paroxysmal, Recurrence, Superior Vena Cava Isolation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centro Medico TeknonUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 8 Aug 2025 (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.
Atrial fibrillation is the most common arrhythmia in the population and is often caused by arrhythmogenic foci located in the pulmonary veins. For this reason, the first attempt in atrial fibrillation catheter ablation procedures is to isolate these structures (the procedure is called indeed "pulmonary vein isolation"), which results in abolishment of arrhythmia recurrence in up to 85% of patients at short and mid-term follow-up. However, a subset of patients experience an atrial tachyarrhytmia recurrence and a second catheter ablation procedure has to be performed. If pulmary vein isolation is proven to be durable, other arrhythmogenic foci could be implicated in arrhythmia recurrence. Among extra-pulmonary vein foci, superior vena cava has been described as the most frequently involved in atrial fibrillation initiation. Therefore, its ablation could result in improved freedom from atrial fibrillation episodes during follow-up. In the present study, we sought to evaluate the safety and effectiveness of empirical superior vena cava isolation in terms of arrhythmia-free survival in patients with paroxysmal atrial fibrillation recurrence despite durable pulmonary vein isolation.
Detailed description
Atrial fibrillation (AF) is the most frequent arrhythmia in the general population (1), with an expected doubling in prevalence within 2060 (2). Since the late 1990s (3), pulmonary vein isolation (PVI) has become a cornerstone in drug refractory AF treatment, and more recently has emerged a first line therapy in paroxysmal AF patients (4) due to its proven superiority to antiarrhythmic drugs in achieving arrhythmia-free survival (5).
PVI is a safe and effective procedure in the vast majority of patients with paroxysmal AF, with high AF-free survival at mid- and long-term follow-up. In case of AF recurrence, repeat ablation of pulmonary vein reconnections demonstrated superior outcomes compared to the use of anti-arrhythmic drugs in both paroxysmal and persistent AF (6). Nevertheless, a subset of patients with AF recurrence results to be "PVI non-responder", with arrhythmia recurrence despite durable ablation results (7). How to manage these patients is still a matter of debate, with different additional lesion sets proposed so far (8).
Non-PVI triggers have been implicated in AF initiation, with superior vena cava (SVC) being the most common of them (9,10). Empirical SVC isolation has been attempted in some observational as well as randomized study (11-14), but definitive conclusion could not be drawn due to lack of statistical power as well as variable eligibility criteria (first vs repeat procedure, paroxysmal vs persistent AF) and ablation sets (15).
In the present study, we sought to evaluate the safety and effectiveness of empirical SVC isolation in terms of arrhythmia-free survival in patients with paroxysmal AF recurrence despite durable PVI.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SVC isolation group | Active comparator | Procedure: Empirical superior vena cava isolationEmpirical superior vena cava isolation |
| Control arm | Sham comparator | Procedure: Ablation without empirical superior vena cava isolationNo empirical superior vena cava isolation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years.
- Confirmed diagnosis of recurrent paroxysmal AF
- Previous transcatheter PVI-only procedure for AF.
- Evidence of persistently isolated pulmonary veins at repeat procedure.
- Signed informed consent.
Key exclusion criteria (8 listed)
- Age < 18 years.
- Pregnancy.
- Concomitant investigation treatments.
- Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.
- Lesions other than PVI performed during first procedure
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 |
|---|---|---|
| Empirical superior vena cava isolationEmpirical superior vena cava isolation with radiofrequency ablation | Procedure or surgery | SVC isolation group |
| Ablation without empirical superior vena cava isolationNo ablation or ablation of other arrhythmic foci wuthout empirical superior vena cava isolation | Procedure or surgery | Control arm |
Primary outcome
Arrhythmia-free survival
Time frame: 12 months follow-up
Occurence of any sustained atrial arrhythmia (AF, atrial flutter or any atrial tachycardia) lasting ≥ 30 s, after a 2-month blanking period
1 secondary outcome
Procedure-related complications
Time frame: 12 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
Diego Penela, MD, PhD contact
Antonio Berruezo, MD, PhD principal investigator
Teknon Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empirical superior vena cava isolation and Ablation without empirical superior vena cava isolation in people with Paroxysmal AF, run by Centro Medico Teknon 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 5 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: opening soon, as of the sponsor's last update on 8 Aug 2025. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Berruezo, MD, PhD (93 290 62 51 ext. + 34, antonio.berruezo@quironsalud.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arrhythmia-free survival (time frame: 12 months 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 8 Aug 2025.