Dual Energy Focal Ablation of Premature Ventricular Complexes (DUAL-PVC)

Dual Energy (RF/PF) Focal Ablation of Premature Ventricular Complexes: the DUAL-PVC Prospective Clinical Trial

The purpose of this research is to understand whether a dual-energy catheter ablation system that uses radiofrequency (RF) and pulsed-field (PF) energy can safely and effectively treat premature ventricular contractions (PVCs).

Study Overview

• Status: Not yet recruiting
• Conditions: Premature Ventricular Contractions
• Intervention / Treatment: Device: Dual Energy THERMOCOOL SMARTTOUCH™ SF (STSF) Bi-Directional Navigation catheter with TRUPULSE™ Generator

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Konstantinos Siontis, MD; Phone Number: 507-255-0774; Email: siontis.konstantinos@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ≥10% burden of the target PVC on ambulatory rhythm monitoring within 3 months prior to enrollment. The qualifying ambulatory monitor may be of any duration (1-30 days) per standard of care and may be distinct from the baseline 12-lead Holter required within 30 days before ablation

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

  • Patients with symptomatic PVCs for whom antiarrhythmic medications are ineffective, not tolerated, or not the patient's preference.
  • Suspected or confirmed PVC-induced cardiomyopathy
  • Enrollment of patients requiring a redo procedure will be capped at 30% of planned enrollment (n=18) if the target PVC is the same or similar to that targeted in previous procedure(s), per review of the study investigator

• Patients with and without known structural heart disease are eligible

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

• Ability to undergo study-directed post-ablation coronary CT angiography

• Ability to provide written informed consent

Exclusion Criteria:

• LVEF <35%
• NYHA class IV
• Presence of multifocal PVCs (>=3 distinct morphologies) on available pre-baseline standard-of-care ambulatory monitor and ECG tracings per the review of the study team.
• PVCs attributable to a reversible or non-cardiac cause (e.g., electrolyte imbalance or active thyroid disease).
• History of sustained VT or VF.
• Current or recent (<4 weeks) decompensated heart failure.
• Active systemic infection.
• Contraindication to LGE-MRI or contrast CT.
• Known allergy to iodinated contrast dye that cannot be adequately managed with pre-medication protocol.
• Thrombocytopenia (platelet count <50,000/mm³) or known coagulopathy.
• Contraindication to systemic anticoagulation.
• 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 intracardiac 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RF-PF Sequential Ablation; Participants are assigned to receive radiofrequency (RF) followed by pulsed-field (PF) at each selected treatment site. For each PF treatment, 24 PF bursts are delivered. Up to three stacked lesions may be performed at the same location.	Device: Dual Energy THERMOCOOL SMARTTOUCH™ SF (STSF) Bi-Directional Navigation catheter with TRUPULSE™ Generator; The THERMOCOOL SMARTTOUCH™ SF Bi-Directional Navigation Catheter is an irrigated, contact-force-sensing catheter used to map the heart and deliver radiofrequency (RF) or pulsed-field (PF) energy to selected treatment sites. The catheter is connected to the TRUPULSE™ Generator, which provides both energy types, and to the nGEN™ Pump, which controls saline irrigation. The system is used with the CARTO™ 3 electroanatomic mapping system and workstation with the VISITAG SURPOINT™ Module to display heart anatomy, catheter location, catheter-to-tissue contact, and treatment information during the procedure.
Experimental: PF-Only Ablation; Participants are assigned to receive pulsed-field (PF) alone at each selected treatment site. For each PF treatment, 24 PF bursts are delivered. Up to three stacked lesions may be performed at the same location.	Device: Dual Energy THERMOCOOL SMARTTOUCH™ SF (STSF) Bi-Directional Navigation catheter with TRUPULSE™ Generator; The THERMOCOOL SMARTTOUCH™ SF Bi-Directional Navigation Catheter is an irrigated, contact-force-sensing catheter used to map the heart and deliver radiofrequency (RF) or pulsed-field (PF) energy to selected treatment sites. The catheter is connected to the TRUPULSE™ Generator, which provides both energy types, and to the nGEN™ Pump, which controls saline irrigation. The system is used with the CARTO™ 3 electroanatomic mapping system and workstation with the VISITAG SURPOINT™ Module to display heart anatomy, catheter location, catheter-to-tissue contact, and treatment information during the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Successful Delivery of Ablation Lesions Using the Dual-Energy THERMOCOOL SMARTTOUCH SF Catheter With the TRUPULSE Generator	Feasibility is defined as successful delivery of ablation energy at the targeted premature ventricular complex (PVC) site. Delivery counts as successful only if there is no study device deficiency or malfunction that prevents energy delivery, and no need to convert to a bailout ablation approach.	During the index ablation procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute procedural success	Number of participants with elimination of the target premature ventricular contraction by the end of the procedure.	End of the ablation procedure
Participants with greater than 80% reduction in target PVC burden	Number of participants with greater than 80% reduction from baseline in the burden of the target premature ventricular contraction on Holter monitoring.	1 month, 6 months
Change in Short Form Health Survey (SF-36) score	The 36-Item Short Form Health Survey (SF-36) is a participant-reported questionnaire that assesses health-related quality of life across eight domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Total scores range from 0 to 100. Higher scores indicate better health status.	Baseline, 1 month, 6 months
Change in EQ-5D score	The EQ-5D is a participant-reported measure of health-related quality of life covering five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses across the five dimensions define the participant's health state. Higher scores indicate better health.	Baseline, 1 month, 6 months
Number of Participants With New Coronary Artery Stenosis on Coronary CT Angiography at 6 Months After Ablation	Total number of patients with new-onset coronary luminal stenosis found on CT coronary angiography	6 months
Total Procedure Time	Total procedure time will be reported in minutes	From start to finish of index ablation procedure
Electrogram endpoints	EGM amplitude changes after PF, RF, and RF-PF lesion delivery	Intraprocedure
Ablation Lesion Depth	Maximum depth of the ablation lesion at the target premature ventricular complex (PVC) site. Depth is measured from the endocardial surface on late gadolinium enhancement (LGE) cardiac MRI. Only participants with an evaluable post-ablation MRI are analyzed. Reported in millimeters.	1 month and 6 months after ablation
Ablation Lesion Width	Maximum width of the ablation lesion at the target PVC site, measured on LGE cardiac MRI. Only participants with an evaluable post-ablation MRI are analyzed. Reported in millimeters.	1 month and 6 months after ablation
Ablation Lesion Volume	Total volume of the ablation lesion at the target PVC site, measured on LGE cardiac MRI. Only participants with an evaluable post-ablation MRI are analyzed. Reported in cubic centimeters.	1 month and 6 months after ablation
Number of Radiofrequency (RF) Lesions Delivered per Participant	Total number of RF lesions delivered with the study catheter during the index procedure	During the index ablation procedure
Number of Pulsed-Field (PF) Lesions Delivered per Participant	Total number of PF lesions delivered with the study catheter during the index procedure	During the index ablation procedure

Collaborators and Investigators

• Sponsor: Konstantinos Siontis
• Investigators: Principal Investigator: Konstantinos Siontis, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: October 21, 2026
• First Submitted That Met QC Criteria: November 8, 2026
• First Posted (Actual): November 13, 2026

Study Record Updates

• Last Update Posted (Actual): November 13, 2026
• Last Update Submitted That Met QC Criteria: November 8, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Cardiac Complexes, Premature; Pathological Conditions, Signs and Symptoms; Ventricular Premature Complexes
• Other Study ID Numbers: 25-013930

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes