Dual Energy (RF/PF) Focal Ablation Of Premature Ventricular Complexes

Overview

About this study

The purpose of this study is to evaluate acute procedural efficacy defined by successful elimination of targeted PVCs; To assess periprocedural and 6-month safety endpoints including adverse events, biomarker evidence of myocardial injury, and imaging evidence of tissue response; To determine clinical effectiveness at 6 months in terms of PVC burden reduction, quality of life, and ventricular function.

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:

  • Age ≥18 years.

  • ≥10% burden of the target PVC on Holter monitoring <3 months prior to enrollment.

  • Guideline-supported indication for first-time or redo catheter ablation of PVCs at the judgement of the electrophysiologist.

    • Enrollment of patients requiring a redo procedure will be capped at 30% of the planned enrollment (ie. n=18 patients) if the target PVC is the same or similar to the PVC targeted in the previous procedure(s).

  • Patients with and without known structural heart disease will be eligible.

  • Ability to undergo study-directed cardiac MRI pre- and post-procedure.

  • Ability to undergo study-directed post-ablation coronary CT angiogram post-procedure.

  • Ability to provide written informed consent.

Exclusion Criteria:

  • LVEF <35%

  • NYHA class IV

  • History of sustained VT or VF

  • Current or recent (<4 weeks) decompensated heart failure.

  • Active systemic infection.

  • Contraindication to LGE-MRI or contrast CT.

  • Severe valvular disease requiring future intervention.

  • Mechanical valve prosthesis.

  • Pregnancy.

  • Recent acute coronary syndrome (<6 months).

  • Un-revascularized coronary artery disease.

  • Presence of left ventricular assist device (LVAD) or transplanted heart.

  • Presence of LV thrombus.

  • Current use of inotropes.

  • Recent stroke or TIA (<6 months).

  • Presence of a systemic illness likely to limit survival to <1 year.

  • Patient enrollment in other clinical study that could conflict with the current investigation.

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

Eligibility last updated 12/2/2025. 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

Rochester, Minn.

Mayo Clinic principal investigator

Konstantinos Siontis, M.D.

Contact us for the latest status

Contact information:

CVRU Heart Rhythm Services Research Team

(507) 255-0774

More information

Publications

Publications are currently not available