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

8. november 2026 opdateret af: Konstantinos Siontis

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).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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.
Eksperimentel: 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.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Successful Delivery of Ablation Lesions Using the Dual-Energy THERMOCOOL SMARTTOUCH SF Catheter With the TRUPULSE Generator
Tidsramme: During the index ablation procedure

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acute procedural success
Tidsramme: End of the ablation procedure

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
Tidsramme: 1 month, 6 months

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
Tidsramme: Baseline, 1 month, 6 months

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
Tidsramme: Baseline, 1 month, 6 months

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
Tidsramme: 6 months

Total number of patients with new-onset coronary luminal stenosis found on CT coronary angiography
6 months
Total Procedure Time
Tidsramme: From start to finish of index ablation procedure

Total procedure time will be reported in minutes
From start to finish of index ablation procedure
Electrogram endpoints
Tidsramme: Intraprocedure

EGM amplitude changes after PF, RF, and RF-PF lesion delivery
Intraprocedure
Ablation Lesion Depth
Tidsramme: 1 month and 6 months after ablation

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
Tidsramme: 1 month and 6 months after ablation

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
Tidsramme: 1 month and 6 months after ablation

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
Tidsramme: During the index ablation procedure

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
Tidsramme: During the index ablation procedure

Total number of PF lesions delivered with the study catheter during the index procedure
During the index ablation procedure

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Konstantinos Siontis

Efterforskere

  • Ledende efterforsker: Konstantinos Siontis, MD, Mayo Clinic

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. januar 2027

Primær færdiggørelse (Anslået)

1. januar 2029

Studieafslutning (Anslået)

1. juni 2029

Datoer for studieregistrering

Først indsendt

21. oktober 2026

Først indsendt, der opfyldte QC-kriterier

8. november 2026

Først opslået (Faktiske)

13. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 25-013930

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

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