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Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead

19 ottobre 2020 aggiornato da: Abbott Medical Devices

Accent Magnetic Resonance Imaging Pacemaker and Tendril Magnetic Resonance Imaging™ Lead Investigational Device Exemption Study

The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRI™ System in a patient population indicated for implant of a pacemaker within and outside of the MRI environment.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRI System in a patient population indicated for implant of a pacemaker within and outside of the MRI environment. The study consisted of two phases, a Lead Safety Phase which evaluated the safety of the Tendril MRI lead, and an MRI Phase which evaluated the safety and efficacy of the Accent MRI pacemaker system in an MRI environment.

The safety and efficacy of the Accent MRI pacemaker and Tendril MRI lead will be evaluated as described below:

Lead Safety Safety of the Tendril MRI™ lead will be evaluated in terms of freedom from right atrial (RA) and right ventricle (RV) lead-related complications at implant to 2 months (acute timeframe), and at the 2 through the 12 month visit (chronic timeframe).

MRI Safety The safety of the Accent MRI™ system will be evaluated in terms of freedom from MRI scan related complications in the month following the MRI scan.

Lead Efficacy Efficacy of the Tendril MRI™ lead will be evaluated in terms of the change in atrial and ventricular capture and sensing thresholds before and after the MRI scan.

MRI Efficacy Efficacy of the Tendril MR lead will be evaluated in terms of the change in bipolar atrial and ventricular capture and sensing thresholds before and after the MRI scan.

Secondary Endpoints Safety Safety of the Accent MRI™ system will be evaluated in terms of freedom from system-related complications through the 12 month visit.

Efficacy Efficacy of the Tendril MRI™ lead will be evaluated in terms of the atrial and ventricular capture thresholds at the MRI Visit.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

950

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.

Luoghi di studio

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • St. Andrews Hospital
  • Belgio
    • B Cap R
      • Brussels, B Cap R, Belgio, 1200
        • Cliniques Universitaires Saint Luc
  • Finlandia
    • East Finland
      • Kuopio, East Finland, Finlandia, 70211
        • Kuopio University Hospital
  • Olanda
      • Utrecht, Olanda, 3582 KE
        • Diakonessenhuis Utrecht
  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35233
        • University Hospital of Alabama at Birmingham
      • Huntsville, Alabama, Stati Uniti, 35801
        • Heart Center Research
    • Arizona
      • Phoenix, Arizona, Stati Uniti, 85016
        • Arizona Arrhythmia Research Center
    • Arkansas
      • Little Rock, Arkansas, Stati Uniti, 72211
        • Arkansas Heart Hospital
      • Little Rock, Arkansas, Stati Uniti, 72205
        • Baptist Health Medical Center
      • Rogers, Arkansas, Stati Uniti, 72758
        • Mercy Hospital Northwest Arkansas
    • California
      • Bakersfield, California, Stati Uniti, 93308
        • Central Cardiology
      • Burbank, California, Stati Uniti, 91505
        • Raymond Schaerf, MD
      • Concord, California, Stati Uniti, 94520
        • John Muir Medical Center
      • Fullerton, California, Stati Uniti, 92835
        • St. Jude Hospital
      • Glendale, California, Stati Uniti, 91206
        • Glendale Adventist Medical Center
      • La Jolla, California, Stati Uniti, 92037
        • Scripps Green Hospital
      • Modesto, California, Stati Uniti, 95355
        • Memorial Medical Center
      • Newport Beach, California, Stati Uniti, 92629
        • Premier Cardiology, Inc / Hoag Hospital
      • Rancho Mirage, California, Stati Uniti, 92270
        • Desert Cardiology Consultants
      • Sacramento, California, Stati Uniti, 95819
        • Mercy General Hospital
      • Sacramento, California, Stati Uniti, 95819
        • Sutter Memorial Hospital
    • Colorado
      • Denver, Colorado, Stati Uniti, 80012
        • Aurora Denver Cardiology Associates
      • Littleton, Colorado, Stati Uniti, 80120
        • South Denver Cardiology Associates PC
      • Loveland, Colorado, Stati Uniti, 80538
        • Medical Center of the Rockies
    • Florida
      • Atlantis, Florida, Stati Uniti, 33462
        • Medical Specialists of the Palm Beaches
      • Lakeland, Florida, Stati Uniti, 33647
        • Watson Clinic Center
      • Orlando, Florida, Stati Uniti, 32803
        • Florida Hospital Orlando
      • Orlando, Florida, Stati Uniti, 32806
        • Orlando Health
      • Rockledge, Florida, Stati Uniti, 32955
        • Brevard Cardiovascular Research Associates
      • Tallahassee, Florida, Stati Uniti, 32308
        • Tallahassee Research Institute
      • Tampa, Florida, Stati Uniti, 33606
        • University of South Florida, Cardiovascular Services
    • Georgia
      • Athens, Georgia, Stati Uniti, 30606
        • Athens Cardiology Group, PC
      • Atlanta, Georgia, Stati Uniti, 30041
        • Atlanta Heart Specialist
    • Illinois
      • Springfield, Illinois, Stati Uniti, 62701
        • Prairie Education And Research Cooperative
    • Kentucky
      • Lexington, Kentucky, Stati Uniti, 40503
        • Central Baptist Hospital
    • Louisiana
      • New Orleans, Louisiana, Stati Uniti, 70121
        • Ochsner Medical Center
    • Michigan
      • Grand Rapids, Michigan, Stati Uniti, 49503
        • Spectrum Health
      • Lansing, Michigan, Stati Uniti, 48910
        • Thoracic Cardio Healthcare Foundation
      • Southfield, Michigan, Stati Uniti, 48075
        • Providence Hospital
    • Minnesota
      • Minneapolis, Minnesota, Stati Uniti, 55407
        • Minneapolis Heart Institute
    • Missouri
      • Kansas City, Missouri, Stati Uniti, 64111
        • St. Luke's Hospital
      • Saint Louis, Missouri, Stati Uniti, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, Stati Uniti, 63131
        • Missouri Baptist Medical Center
    • Nebraska
      • Omaha, Nebraska, Stati Uniti, 68124
        • Alegent Creighton Health
    • New York
      • Rochester, New York, Stati Uniti, 14450
        • University of Rochester Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, Stati Uniti, 27599-7075
        • University of North Carolina at Chapel Hill
      • Charlotte, North Carolina, Stati Uniti, 28204
        • Mid Carolina Cardiology
      • Winston-Salem, North Carolina, Stati Uniti, 27615
        • Wake Forest University Medical Center Clinical Sciences
    • Ohio
      • Cleveland, Ohio, Stati Uniti, 44195
        • The Cleveland Clinic Foundation
      • Columbus, Ohio, Stati Uniti, 43210
        • The Ohio State University
      • Columbus, Ohio, Stati Uniti, 43213
        • Columbus Cardiovascular Associates
      • Elyria, Ohio, Stati Uniti, 44035
        • EMH Regional Medical Center
      • Youngstown, Ohio, Stati Uniti, 44501
        • St. Elizabeth Health Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73112
        • INTEGRIS Baptist Medical Center
      • Tulsa, Oklahoma, Stati Uniti, 73112
        • Oklahoma Heart Institute at Utica
    • Pennsylvania
      • Abington, Pennsylvania, Stati Uniti, 72758
        • Abington Medical Specialists
      • Pittsburgh, Pennsylvania, Stati Uniti, 15212
        • Allegheny Singer Research Institute
      • Sayre, Pennsylvania, Stati Uniti, 18840
        • Donald Guthrie Foundation for Education and Research
      • York, Pennsylvania, Stati Uniti, 17403
        • York Hospital
    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29401
        • Medical University of South Carolina
      • Charleston, South Carolina, Stati Uniti, 29406
        • PMG Research of Charleston, LLC
    • Texas
      • Austin, Texas, Stati Uniti, 78756
        • Austin Heart
      • San Antonio, Texas, Stati Uniti, 78201
        • South Texas Cardiovascular Consultants
      • Temple, Texas, Stati Uniti, 76508
        • Scott & White Memorial Hospital
    • Virginia
      • Charlottesville, Virginia, Stati Uniti, 22911
        • Martha Jefferson Hospital
      • Manassas, Virginia, Stati Uniti, 20109
        • Virginia Cardiovascular Associates, PC
      • Norfolk, Virginia, Stati Uniti, 23507
        • Sentara Norfolk General Hospital
    • Washington
      • Bremerton, Washington, Stati Uniti, 98310
        • Kitsap Cardiology Consultants
      • Seattle, Washington, Stati Uniti, 98101
        • The Heart Institute at Virginia Mason
    • Wisconsin
      • Milwaukee, Wisconsin, Stati Uniti, 14450
        • Aurora Medical Group

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

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

Eligible patients will meet all of the following:

  1. Have an approved indication per American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Rhythm Society (HRS) guidelines for implantation of a pacemaker
  2. Will receive a new pacemaker and lead
  3. Be willing to undergo an elective MRI scan without sedation
  4. Be able to provide informed consent for study participation (legal guardian is NOT acceptable)
  5. Be willing and able to comply with the prescribed follow-up tests and schedule of evaluations
  6. Is not contraindicated for an MRI scan (per the pre-MRI safety screening form)

Exclusion Criteria:

Patients will be excluded if they meet any of the following:

  1. Are medically indicated for an MRI scan at the time of enrollment
  2. Have an existing pacemaker or implantable cardioverter defibrillator (ICD). A new pacemaker and lead is required for enrollment
  3. Have an existing active/inactive implanted medical device, e.g., neurostimulator, infusion pump, etc.
  4. Have a non-MRI compatible device or material implanted (e.g., intracranial aneurysm clip, non-MRI compatible devices or material, metals or alloys, etc.)
  5. Have a lead extender or adaptor
  6. Be unable to fit in MRI bore; will come into contact with the magnet façade inside the MRI bore.
  7. Have a prosthetic tricuspid heart valve
  8. Are currently participating in a clinical investigation that includes an active treatment arm
  9. Are allergic to dexamethasone sodium phosphate (DSP)
  10. Are pregnant or planning to become pregnant during the duration of the study
  11. Have a life expectancy of less than 12 months due to any condition
  12. Patients with exclusion criteria required by local law (e.g., age)
  13. Are unable to comply with the follow up schedule

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: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Lead Safety
Patient implanted with an Accent MRI system to evaluate safety of the Tendril MRI lead
Dispositivo: Accent MRI system (lead safety)
Patients implanted with an Accent MRI system
Altri nomi:
  • Accent MRI pacemaker
  • Tendril MRI lead
Sperimentale: Accent MRI system MRI Scan Group
Patient implanted with an Accent MRI system will receive an MRI scan to evaluate safety and efficacy of the Accent MRI system in an MRI environment
Dispositivo: Accent MRI system (with MRI scan)
Patients implanted with an Accent MRI system will receive an MRI scan
Altri nomi:
  • Accent MRI pacemaker
  • Tendril MRI lead

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Freedom From Right Atrial (RA) Lead-related Complications in the Acute Period
Lasso di tempo: Implant through 2 months
Percentage of patients who do not have RA lead-related complications from implant through the 2 month study visit
Implant through 2 months
Freedom From Right Ventricular (RV) Lead-related Complications in the Acute Time Period
Lasso di tempo: Implant through 2 months
Percentage of patients who do not have RV lead-related complications from implant through the 2 month study visit
Implant through 2 months
Freedom From RA Related Complications in the Chronic Period
Lasso di tempo: 2 months through 12 months
Percentage of patients who do not have RA lead-related complications from the 2 month through the 12 month study visit
2 months through 12 months
Freedom From Right Ventricular Lead Related Complications in the Chronic Period
Lasso di tempo: 2 months through 12 months
Percentage of patients who do not have RV lead-related complications from the 2 month through the 12 month study visit
2 months through 12 months
Freedom From MRI Scan-related Complications
Lasso di tempo: MRI Scan visit through 1 month after MRI scan visit
Percentage of patients who do not have MRI-related complications from the MRI scan visit to the 1 month post MRI scan visit
MRI Scan visit through 1 month after MRI scan visit
Change in Atrial Capture Threshold From Pre to Post MRI Scan
Lasso di tempo: MRI Scan visit to 1 month after MRI scan visit
Percentage of patients with an increase in RA capture thresholds of <= 0.5 V, at a pulse width of 0.5 ms .
MRI Scan visit to 1 month after MRI scan visit
Change in Ventricular Capture Threshold Pre to Post MRI Scan
Lasso di tempo: MRI Scan visit to 1 month after MRI scan visit
Percentage of patients with an increase in RV capture thresholds of <=0.5V, at a pulse width of 0.5 ms.
MRI Scan visit to 1 month after MRI scan visit
Change in Atrial Sense Amplitude
Lasso di tempo: MRI Scan visit to 1 month after MRI scan visit
Percentage of patients with a reduction in RA sense amplitude <=50 % and sense amplitude >=1.5 mV.
MRI Scan visit to 1 month after MRI scan visit
Change in Ventricular Sense Amplitude
Lasso di tempo: MRI Scan visit to 1 month after the MRI Scan visit
Percentage of patients with an reduction in RV sense amplitude <=50% and sense amplitude >=5 mV.
MRI Scan visit to 1 month after the MRI Scan visit

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Freedom From System-related Complications
Lasso di tempo: Implant through 12 months
Percentage of patients who do not have system-related complications from implant through the 12 month study visit
Implant through 12 months
Atrial Capture Threshold at the MRI Visit
Lasso di tempo: MRI Scan visit (approx 3 months post implant)
Percentage of patients with RA capture threshold ≤2.0 volts (V) at the MRI visit
MRI Scan visit (approx 3 months post implant)
Ventricular Capture Threshold at the MRI Visit
Lasso di tempo: MRI Scan visit (approx 3 months post implant)
Percentage of patients with RV capture threshold ≤2.0 V at the MRI visit
MRI Scan visit (approx 3 months post implant)

Collaboratori e investigatori

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

Sponsor

Abbott Medical Devices

Investigatori

  • Direttore dello studio: Grant Kim, Abbott Medical Devices

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 (Effettivo)

30 marzo 2012

Completamento primario (Effettivo)

2 febbraio 2018

Completamento dello studio (Effettivo)

2 febbraio 2018

Date di iscrizione allo studio

Primo inviato

4 aprile 2012

Primo inviato che soddisfa i criteri di controllo qualità

10 aprile 2012

Primo Inserito (Stima)

12 aprile 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 novembre 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 ottobre 2020

Ultimo verificato

1 ottobre 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 60028820

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 .

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