Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

8 novembre 2026 aggiornato da: 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).

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • Minnesota
      • Rochester, Minnesota, Stati Uniti, 55905
        • Mayo Clinic

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: 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.
Sperimentale: 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.
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Successful Delivery of Ablation Lesions Using the Dual-Energy THERMOCOOL SMARTTOUCH SF Catheter With the TRUPULSE Generator
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Acute procedural success
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 6 months

Total number of patients with new-onset coronary luminal stenosis found on CT coronary angiography
6 months
Total Procedure Time
Lasso di tempo: 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
Lasso di tempo: Intraprocedure

EGM amplitude changes after PF, RF, and RF-PF lesion delivery
Intraprocedure
Ablation Lesion Depth
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: During the index ablation procedure

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Konstantinos Siontis

Investigatori

  • Investigatore principale: Konstantinos Siontis, MD, Mayo Clinic

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 gennaio 2027

Completamento primario (Stimato)

1 gennaio 2029

Completamento dello studio (Stimato)

1 giugno 2029

Date di iscrizione allo studio

Primo inviato

21 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 novembre 2026

Primo Inserito (Effettivo)

13 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 25-013930

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi