Find trials
Search tips

A Study Assessing Long-Term Safety And Effectiveness In Treatment Management Of Atrial Fibrillation With VARIPULSE Catheter System

Overview

About this study

The purpose of this study is to evaluate the long-term safety and effectiveness of the VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

* Symptomatic paroxysmal Atrial Fibrillation (AF) who, in the opinion of the investigator, are candidates for catheter ablation for AF
* Refractory, intolerant, or contraindicated to Class I/III antiarrhythmic drugs (AAD)
* Willing and capable of providing consent
* Able and willing to comply with all pre-, post-, and follow-up testing and requirements

Exclusion Criteria:

* Previously diagnosed with persistent or long-standing persistent AF (more than \[\>\] 7 days in duration)
* Previous surgical or catheter ablation for AF
* Significant congenital anomaly or medical problem that in the opinion of the investigator would be a contraindication to catheter ablation for AF
* Current enrollment in an investigational study evaluating another device or drug
* Life expectancy less than 12 months
* Any contraindications as defined in the Protocol

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 02/23/2026. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Konstantinos Siontis, M.D.

Contact us for the latest status

Contact information:

Danesh Kella

9049530859

kella.danesh@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Konstantinos Siontis, M.D.

Open for enrollment

More information

Publications

Publications are currently not available

More about research at Mayo Clinic

.
CLS-20603162

Mayo Clinic Footer