Paroxysmal Atrial FibrillationRECONNECTNCT04602169
Added Value of SVC Isolation in Patients With Pulmonary Vein Reconnection Undergoing Repeat Ablation for Recurrent Paroxysmal AF
A study testing PVI and PVI + SVC in people with Paroxysmal Atrial Fibrillation, run by AZ Sint-Jan AV at 1 site in Belgium.
Trial summary
Redo procedures after CLOSE-guided pulmonary vein isolation (PVI) for atrial fibrillation (AF) occur in 10% of patients. In case of pulmonary vein (PV) reconnection, electrophysiologists may re-isolate the pulmonary veins with or without the ablation of other commonly known PV-triggers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- PVI and PVI + SVC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Nov 2020to 30 Sep 2023
- 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
- Patients older than 18 years
- Patients scheduled for a repeat ablation of PAF after a previous PVI
- PV reconnection (in ≥1 PV's) found during procedure at the time of randomization
Who cannot join
- Patients with persistent AF
- Patients with durable PVI (no PVR)
- Previous ablation with isolation of the SVC, roofline, mitral line or previous vein of Marshal ethanol infusion
- Left atrial thrombus. LAA thrombus can be determined by preprocedural imaging: CT, TEE or MRI.
- Left ventricular ejection fraction <35%.
- Cardiac surgery within the previous 90 days.
Show all 23Show fewer
- Expecting cardiac transplantation or other cardiac surgery within 180 days.
- Coronary PTCA/stenting within the previous 90 days or myocardial infarction within the previous 60 days.
- Documented history of a thromboembolic event within the previous 90 days.
- Diagnosed atrial myxoma.
- Significant restrictive, constrictive, or chronic obstructive pulmonary disease with chronic symptoms.
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
- Women who are pregnant or who plan to become pregnant between signing the informed consent form and the index ablation.
- Acute illness or active infection at time of index procedure
- Advanced renal insufficiency
- Unstable angina.
- History of blood clotting or bleeding abnormalities.
- Contraindication to anticoagulation.
- Life expectancy less than 1 year.
- Presence of a condition that precludes vascular access.
- INR greater than 3.5 within 24 hours of procedure - for patients taking warfarin.
- Patient cannot be removed from antiarrhythmic drugs for reasons other than AF.
- Unwilling or unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
AZ Sint-Jan Brugge-Oostende AV
Bruges, Please Select, 8000
Michelle Lycke, MSc, PhD, 00 32 45 32 93, michelle.lycke@azsintjan.be
About this study
Official title: Added Value of Superior Vena Cava Isolation in Patients With Pulmonary Vein Reconnection Undergoing Repeat Ablation for Recurrent Paroxysmal Atrial Fibrillation
Redo procedures after CLOSE-guided pulmonary vein isolation (PVI) for atrial fibrillation (AF) occur in 10% of patients. In case of pulmonary vein (PV) reconnection, electrophysiologists may re-isolate the pulmonary veins with or without the ablation of other commonly known PV-triggers. The superior vena cava (SVC) is one of the most common non PV-triggers for atrial tachyarrhythmias. SVC electrical isolation can be reached by circular radiofrequency-ablation under close monitoring of the phrenic nerve. However, it's added value remains unclear.
With this prospective, randomized, controlled, unblinded, mono-center study, the investigators aim to evaluate the 1-year recurrence rate in paroxysmal AF patients with reconnected pulmonary veins during a redo ablation with PV re-isolation or PV re-isolation with SVC isolation.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- PVI, PVI + SVC
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVIProcedure or surgery
PV re-isolation will be conducted according to the CLOSE-protocol. Point-by-point radiofrequency (RF) delivery will be performed aiming for a contiguous circle enclosing all PVs. RF will be delivered in a power-controlled mode (without ramping) using 35-40 Watt. The irrigation rate will be set at 30 ml/min. RF will be delivered until an ablation index (AI) of ≥400 is reached at the posterior wall and ≥550 at the anterior wall. In case of dislocation, a new RF application reaching the AI target will be applied. Maximal intertag distance between two neighboring lesions is 6 mm. In case of intra-esophageal temperature (T°) rise >38.5°C during posterior LA wall ablation, RF delivery will stopped at an AI of 300. In the absence of first pass isolation, touch-up ablation was applied until PVI. In case of reconnection during the waiting time or during the adenosine test, the site of reconnection will be located and treated with touch-up ablation until adenosine proof PVI is reached.
PVI + SVCProcedure or surgery
Patients in this group receive PVI according to the CLOSE protocol. In addition, they will receive an SVC isolation. The circular mapping catheter will be introduced in the superior vena cava to determine baseline electrical activity and to confirm definite entrance and exit block after ablation. Ablation will be performed proximally to the SVC/right atrial junction with the contact force-catheter using circular point-by-point radiofrequency delivery with a power setting of 35W, targeting an AI ≥400. High output (25 mA) pacing will be applied before each RF application to check for phrenic nerve stimulation. In areas of phrenic nerve capture ablation will be avoided even in case of incomplete isolation.
| Study group | Role | What they receive |
|---|---|---|
| PVI only group | Active comparator | Patients allocated to this group will receive PV re-isolation alone Receives: Procedure: PVI |
| PVI + SVC group | Active comparator | Patients allocated to this group will receive PV re-isolation with SVC isolation. Receives: Procedure: PVI + SVC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of atrial tachyarrhythmia 1 year after the index ablation
Measured on 72hr Holter monitoring
Measured: 1 year after ablation
Safety measured by procedural complications
Occurence of procedural complications post procedure
Measured: From time of ablation to 1 month post procedure
Secondary outcomes (6)
Total procedure time
Difference in total procedure time between groups
Measured: At time of ablation
Fluoroscopy time
Difference in fluoroscopy time between groups
Measured: At time of ablation
RF ablation time
Difference in RF ablation time between groups
Measured: At time of ablation
Atrial volume
Evaluation of the atrial volume (ml)
Measured: At time of ablation
SVC width
Evaluation of the SVC width (mm)
Measured: At time of ablation
phrenic nerve width
Evaluation of the phrenic nerve width (mm)
Measured: At time of ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start16 Nov 2020
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal 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
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastien Knecht, AZ Sint-Jan AV
- Investigators
- Sébastien Knecht, MD, PhD, Principal investigator, AZ Sint-Jan AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602169
- Sponsor's protocol ID
- 2721
- Acronym
- RECONNECT
- Status last verified
- Aug 2022
- First submitted
- 20 Oct 2020
- Last updated
- 3 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Added Value of Superior Vena Cava Isolation in Patients With Pulmonary Vein Reconnection Undergoing Repeat Ablation for Recurrent Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04602169
- Acronym / sponsor ID
- RECONNECT / 2721
- Conditions
- Paroxysmal Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 26 Oct 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.
Redo procedures after CLOSE-guided pulmonary vein isolation (PVI) for atrial fibrillation (AF) occur in 10% of patients. In case of pulmonary vein (PV) reconnection, electrophysiologists may re-isolate the pulmonary veins with or without the ablation of other commonly known PV-triggers. The superior vena cava (SVC) is one of the most common non PV-triggers for atrial tachyarrhythmias. SVC electrical isolation can be reached by circular radiofrequency-ablation under close monitoring of the phrenic nerve. However, it's added value remains unclear.
With this prospective, randomized, controlled, unblinded, mono-center study, the investigators aim to evaluate the 1-year recurrence rate in paroxysmal AF patients with reconnected pulmonary veins during a redo ablation with PV re-isolation or PV re-isolation with SVC isolation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVI only group | Active comparator | Procedure: PVIPatients allocated to this group will receive PV re-isolation alone |
| PVI + SVC group | Active comparator | Procedure: PVI + SVCPatients allocated to this group will receive PV re-isolation with SVC isolation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 18 years
- Patients scheduled for a repeat ablation of PAF after a previous PVI
- PV reconnection (in ≥1 PV's) found during procedure at the time of randomization
Key exclusion criteria (23 listed)
- Patients with persistent AF
- Patients with durable PVI (no PVR)
- Previous ablation with isolation of the SVC, roofline, mitral line or previous vein of Marshal ethanol infusion
- Left atrial thrombus. LAA thrombus can be determined by preprocedural imaging: CT, TEE or MRI.
- Left ventricular ejection fraction <35%.
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 |
|---|---|---|
| PVIPV re-isolation will be conducted according to the CLOSE-protocol. Point-by-point radiofrequency (RF) delivery will be performed aiming for a contiguous circle enclosing all PVs. RF will be delivered in a power-controlled mode (without ramping) using 35-40 Watt. The irrigation rate will be set at 30 ml/min. RF will be delivered until an ablation index (AI) of ≥400 is reached at the posterior wall and ≥550 at the anterior wall. In case of dislocation, a new RF application reaching the AI target will be applied. Maximal intertag distance between two neighboring lesions is 6 mm. In case of intra-esophageal temperature (T°) rise >38.5°C during posterior LA wall ablation, RF delivery will stopped at an AI of 300. In the absence of first pass isolation, touch-up ablation was applied until PVI. In case of reconnection during the waiting time or during the adenosine test, the site of reconnection will be located and treated with touch-up ablation until adenosine proof PVI is reached. | Procedure or surgery | PVI only group |
| PVI + SVCPatients in this group receive PVI according to the CLOSE protocol. In addition, they will receive an SVC isolation. The circular mapping catheter will be introduced in the superior vena cava to determine baseline electrical activity and to confirm definite entrance and exit block after ablation. Ablation will be performed proximally to the SVC/right atrial junction with the contact force-catheter using circular point-by-point radiofrequency delivery with a power setting of 35W, targeting an AI ≥400. High output (25 mA) pacing will be applied before each RF application to check for phrenic nerve stimulation. In areas of phrenic nerve capture ablation will be avoided even in case of incomplete isolation. | Procedure or surgery | PVI + SVC group |
Primary outcome
Recurrence of atrial tachyarrhythmia 1 year after the index ablation
Time frame: 1 year after ablation
Measured on 72hr Holter monitoring
Safety measured by procedural complications
Time frame: From time of ablation to 1 month post procedure
Occurence of procedural complications post procedure
6 secondary outcomes
Total procedure time
Time frame: At time of ablation
Fluoroscopy time
Time frame: At time of ablation
RF ablation time
Time frame: At time of ablation
Atrial volume
Time frame: At time of ablation
SVC width
Time frame: At time of ablation
phrenic nerve width
Time frame: At time of ablation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
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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.
Sébastien Knecht, MD, PhD principal investigator
AZ Sint-Jan AV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVI and PVI + SVC in people with Paroxysmal Atrial Fibrillation, run by AZ Sint-Jan AV at 1 site in Belgium.
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 23 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 3 Aug 2022. 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 Belgium. 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 Michelle Lycke, MSc, PhD (003250453293, michelle.lycke@azsintjan.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of atrial tachyarrhythmia 1 year after the index ablation (time frame: 1 year after ablation). 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?
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 3 Aug 2022.