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Patient Perception of MultiPulse Therapy™ (MPT™)

7 oktober 2022 uppdaterad av: Cardialen, Inc.

A Clinical Feasibility Study to Evaluate Patient Perception of MPT

Assess the subject acceptance of MPT, using therapy parameters that have been shown to be effective in terminating episodes of atrial fibrillation.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

A prospective non-randomized feasibility study involving acute testing of MPT in subjects having a history of AF during clinically indicated acute electrophysiology procedures including AF ablation, SVT ablation or diagnostic EP procedures (indicated procedure). The primary outcome of the study is the subject response to questions regarding perception and acceptability following MPT delivery.

Studietyp

Interventionell

Inskrivning (Faktisk)

6

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • South Australia
      • Adelaide, South Australia, Australien
        • Royal Adelaide Hospital
      • Adelaide, South Australia, Australien
        • St. Andrew's Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  1. Male or female between 18 and 80 years of age
  2. Willing and able to comply with the study protocol, provide a written informed consent
  3. History of Atrial Fibrillation in past 12 months
  4. Indicated to undergo an acute electrophysiology procedure allowing for conscious participation in the clinical study
  5. Current treatment and compliance with standard anticoagulation regimen, including uninterrupted OAC, with acceptable coagulation status, as determined by the Principal Investigator

Study stage dependent: Stage 1:

6a. History of DC-Cardioversion in past 12 months: With or Without

7b. AFEQT Score: <=89

Study stage dependent: Stage 2 (based on results from study stage 1):

6a: History of DC-Cardioversion in past 12 months: Potential emphasis on patients with history of DCCV

7b. AFEQT Score: Potential emphasis on patients with AFEQT <= 58

Exclusion Criteria:

  1. Life expectancy of 1 year or less
  2. AF due to reversible causes (e.g., hyperthyroidism, valve disease)
  3. Hx of fibromyalgia or any other evidence of wide-spread pain
  4. Any current pain condition that could be confused with pain or discomfort associated with MPT
  5. >1 current well-defined pain condition (e.g., migraine, joint OA, painful diabetic neuropathy)
  6. Use of any opioid analgesic (including tramadol) within 3 months of screening
  7. Spielberger's STAI-AD-Trait > 75
  8. AFEQT: Section 1: "I was never aware of having atrial fibrillation" is checked
  9. Allergy or contraindication to anticoagulation therapy
  10. Presence of intracardiac thrombus (confirmed with cardiac imaging)
  11. Existing Left Atrial Appendage closure device
  12. LVEF<20%
  13. NYHA Class IV heart failure at the time of enrollment
  14. History of embolic stroke, Transient Ischemic Attack (TIA) or other thromboembolic event within the preceding 3 months.
  15. Known hyper-coagulable state that increases risk of thrombus
  16. History of myocardial infarction or coronary revascularization within the preceding 3 months.
  17. History of sustained ventricular arrhythmia or cardiac arrest
  18. Presence of chronically implanted lead in the CS
  19. Presence of ventricular assist device, including intra-aortic balloon pump
  20. Documented bradycardia (<40 BPM) at the time of the study
  21. Morbid obesity: BMI>39 kg/m2
  22. Presence of any prosthetic cardiac valve
  23. History of significant tricuspid valvular disease requiring surgery
  24. Moderate to severe mitral valve regurgitation (>40% regurgitation fraction)
  25. Cognitive or mental health status that would interfere with study participation and proper informed consent
  26. Cardiovascular anatomical defects that would complicate placement of the stimulation leads required by the protocol, including congenital heart disease and cardiac vein anomalies per the Investigator's discretion
  27. Pregnancy confirmed by test within 7 days of procedure.
  28. Inability to pass catheters to heart due to vascular limitations
  29. Cardiovascular surgery or intervention within 1 month prior to enrollment or planned for up to 1 month after enrollment (other than the planned treatment procedure)
  30. Active endocarditis
  31. History of hemodynamic compromise due to valvular heart disease
  32. Unstable CAD as determined by the investigator
  33. Severe proximal three-vessel or left main coronary artery disease without revascularization as determined by the investigator
  34. History of Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Congenital Heart Anomaly, Cardiac Amyloidosis or Cardiac Sarcoidosis
  35. Any other medical condition which may affect the outcome of this study or safety of the subject as determined by the investigator

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Intervention

The study will be conducted using the venous cannulations that are standard of care for the indicated procedure. Additional access points may be necessary if access to coronary sinus is difficult from existing femoral venous cannulations. Sterile study leads or EP catheters will be temporarily placed into the RA, CS, and RV (for R-wave sensing using intracardiac electrograms - optional) which will be connected to the investigational device (CESS).

Up to two MPTs will be delivered and subject responses following each MPT regarding perception and acceptability of MPT to treat AF will be obtained. MPT voltages will not exceed 100V.

Electrical Stimulation

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Therapy acceptance as measured by a subject question administered immediately following MPT delivery
Tidsram: Immediately following MPT delivery
Question: "Now I want you to think about your experiences with Atrial Fibrillation. Think about how it makes you feel, your daily life while in atrial fibrillation and your experience with in-clinic treatments for atrial fibrillation. If you could use the stimulation you just felt at home and under your control, would you use this stimulation therapy to stop your atrial fibrillation? Please answer yes or no."
Immediately following MPT delivery
Subject perception of MPT as measured by a pain scale administered immediately following MPT delivery
Tidsram: Immediately following MPT delivery
Question: "Please rate any pain you experienced at the time of the stimulus, was it: No pain, mild pain, moderate pain, severe pain, the worst possible pain imaginable."?
Immediately following MPT delivery

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Safety determined from summary report of Adverse Events
Tidsram: Through 30 days post-intervention
Adverse Event frequency by Adverse Event type
Through 30 days post-intervention

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

19 november 2021

Primärt slutförande (Faktisk)

1 oktober 2022

Avslutad studie (Faktisk)

1 oktober 2022

Studieregistreringsdatum

Först inskickad

10 juni 2021

Först inskickad som uppfyllde QC-kriterierna

17 juni 2021

Första postat (Faktisk)

25 juni 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 oktober 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 oktober 2022

Senast verifierad

1 oktober 2022

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • CL008

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

produkt tillverkad i och exporterad från U.S.A.

Ja

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Förmaksflimmer

Kliniska prövningar på MultiPulse Therapy

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