Dual Energy Catheter Ablation for PVCs

(DUAL-PVC Trial)

KS
Overseen ByKonstantinos Siontis, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Konstantinos Siontis
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this 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).

Who Is on the Research Team?

KS

Konstantinos Siontis, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for people who have premature ventricular contractions (PVCs), a type of irregular heartbeat. Specific inclusion and exclusion criteria are not listed, but generally participants should be adults with PVCs and without major health issues that would make the procedure unsafe.

Inclusion Criteria

Enrollment of patients requiring a redo procedure capped at 30% if target PVC is same or similar to previous procedure
Ability to provide written informed consent
≥10% burden of the target PVC on ambulatory rhythm monitoring within 3 months prior to enrollment with monitor duration 1-30 days
See 6 more

Exclusion Criteria

Contraindication to systemic anticoagulation
LVEF <35%
My heart failure is severe and I have symptoms even at rest.
See 19 more

What Are the Treatments Tested in This Trial?

Interventions

  • Dual Energy THERMOCOOL SMARTTOUCH™ SF (STSF) Bi-Directional Navigation catheter with TRUPULSE™ Generator

Trial Overview

The study is testing a new catheter ablation system that uses both radiofrequency (RF) and pulsed-field (PF) energy to treat PVCs. The goal is to see if this dual-energy approach can safely reduce abnormal heartbeats.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: RF-PF Sequential AblationExperimental Treatment1 Intervention
Group II: PF-Only AblationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Konstantinos Siontis

Lead Sponsor

Trials
1
Recruited
8+