Added Value of SVC Isolation in Patients With Pulmonary Vein Reconnection Undergoing Repeat Ablation for Recurrent Paroxysmal AF (RECONNECT)

  • End date
    Sep 30, 2023
  • participants needed
  • sponsor
    AZ Sint-Jan AV
Updated on 9 August 2022
pulmonary vein isolation


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.

Condition Paroxysmal Atrial Fibrillation
Treatment PVI, PVI + SVC
Clinical Study IdentifierNCT04602169
SponsorAZ Sint-Jan AV
Last Modified on9 August 2022


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note