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出境医 / 临床实验 / Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients

Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients

Study Description
Brief Summary:
It is a prospective, randomized and double-blind clinical trial involving an invasive technique for isolation of pulmonary veins (PVAC gold) in relation to clinical treatment during an one year of segment. The patients included have paroxysmal atrial fibrillation (aged 65 years and older) refractory to antiarrhythmic treatments that do not have structural and / or ischemic heart diseases. This trial employs quality of life scores prior to the study and during the sixth and twelfth month of the segment, electrocardiograms and holter of 24 hours. The proposed imaging tests will be the transesophageal echocardiogram before each procedure. The cerebral MRI will be performed in the 24 h post invasive procedure and Angio-tomography of the pulmonary veins in the 6-month segment.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Paroxysmal Cardiac Arrythmias Device: PVAC GOLD catheter ablation Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients
Actual Study Start Date : June 29, 2017
Estimated Primary Completion Date : October 28, 2019
Estimated Study Completion Date : January 25, 2021
Arms and Interventions
Arm Intervention/treatment
No Intervention: Clinical Treatment Group
Experimental: Interventional Ablation Group Device: PVAC GOLD catheter ablation
Isolation of pulmonary veins using PVAC GOLD catheter.
Outcome Measures
Primary Outcome Measures :
  1. Quality of Life Assessment [ Time Frame: 1 year after ablation ]
    Quality of Life in Atrial Fibrillation Questionnaire Score

  2. Recurrence of atrial fibrillation [ Time Frame: 1 year after ablation ]
  3. Occurrence of Asymptomatic Cerebral Embolism [ Time Frame: 1 year of follow-up ]
  4. Esophageal Ulcer [ Time Frame: 1 year of follow-up ]

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Indication for isolation of pulmonary veins
  • Age >= 65 years old

  • Association with the following characteristics:

    1. Symptomatic Atrial Fibrillation;
    2. Sinusal Rhythm maintenance failure for at least 1 Antiarrythmic Drugs;
    3. Diagnosis of Atrial Fibrilation on resting eletrocardiogram and/or 24h Holter.

Exclusion Criteria:

  • Prior Atrial Fibrillation ablation;
  • Atrial Fibrillation permanent and/or persistent;
  • Left atrial size > 55 mm;
  • Mechanical prothetic mitral valve replacement;
  • Presence of atrial thrombus;
  • Cardiac invasive procedure < 90 days;
  • Cerebral embolism < 6 months;
  • Hypertrophic cardiomyopathy;
  • Contraindications to antiocoagulation and cerebral MRI.
Contacts and Locations

Contacts
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Contact: Mauricio I Scanavacca, MD, PhD +55112661-5341 mauricio.scanavacca@gmail.com
Contact: Luiz Claudio B Martins, MD +5513974189969 lcardio@uol.com.br

Locations
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Brazil
Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP Recruiting
Sao Paulo, SP, Brazil, 05403010
Contact: Mauricio I Scanavacca, MD, PhD    +551126615341    mauricio.scanavacca@gmail.com   
Contact: Luiz Claudio B Martins, MD    +5513974189969    lcardio@uol.com.br   
Sub-Investigator: Luiz Claudio B Martins, MD         
Sub-Investigator: Cristiano F Pisani, MD         
Sub-Investigator: Carina A Hardy, MD         
Sub-Investigator: Muhieddine O Chokr, MD         
Sub-Investigator: Sissy L de Melo, MD         
Sub-Investigator: Fabio K Dorfman, MD         
Principal Investigator: Mauricio I Scanavacca, MD         
Sub-Investigator: Francisco C Darrieux, MD         
Sub-Investigator: Cesar J Grupi, MD         
Sub-Investigator: Luciana Sacilotto, MD         
Sub-Investigator: Denise T Hachul, MD         
Sub-Investigator: Tam C Hu, MD         
Sub-Investigator: Savia C Bueno, MD         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Medtronic
Investigators
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Principal Investigator: Mauricio I Scanavacca, MD, PhD Arrythmia Clinical Unit Director
Tracking Information
First Submitted Date  ICMJE July 15, 2019
First Posted Date  ICMJE July 17, 2019
Last Update Posted Date July 23, 2019
Actual Study Start Date  ICMJE June 29, 2017
Estimated Primary Completion Date October 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
  • Quality of Life Assessment [ Time Frame: 1 year after ablation ]
    Quality of Life in Atrial Fibrillation Questionnaire Score
  • Recurrence of atrial fibrillation [ Time Frame: 1 year after ablation ]
  • Occurrence of Asymptomatic Cerebral Embolism [ Time Frame: 1 year of follow-up ]
  • Esophageal Ulcer [ Time Frame: 1 year of follow-up ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 15, 2019)
  • Quality of Life Assessment [ Time Frame: 1 year after ablation ]
    QLAF Questionnaire Score
  • Recurrence of atrial fibrillation [ Time Frame: 1 year after ablation ]
  • Occurrence of Asymptomatic Cerebral Embolism [ Time Frame: 1 year of follow-up ]
  • Esophageal Ulcer [ Time Frame: 1 year of follow-up ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients
Official Title  ICMJE Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients
Brief Summary It is a prospective, randomized and double-blind clinical trial involving an invasive technique for isolation of pulmonary veins (PVAC gold) in relation to clinical treatment during an one year of segment. The patients included have paroxysmal atrial fibrillation (aged 65 years and older) refractory to antiarrhythmic treatments that do not have structural and / or ischemic heart diseases. This trial employs quality of life scores prior to the study and during the sixth and twelfth month of the segment, electrocardiograms and holter of 24 hours. The proposed imaging tests will be the transesophageal echocardiogram before each procedure. The cerebral MRI will be performed in the 24 h post invasive procedure and Angio-tomography of the pulmonary veins in the 6-month segment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Atrial Fibrillation Paroxysmal
  • Cardiac Arrythmias
Intervention  ICMJE Device: PVAC GOLD catheter ablation
Isolation of pulmonary veins using PVAC GOLD catheter.
Study Arms  ICMJE
  • No Intervention: Clinical Treatment Group
  • Experimental: Interventional Ablation Group
    Intervention: Device: PVAC GOLD catheter ablation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 15, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 25, 2021
Estimated Primary Completion Date October 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Indication for isolation of pulmonary veins
  • Age >= 65 years old

  • Association with the following characteristics:

    1. Symptomatic Atrial Fibrillation;
    2. Sinusal Rhythm maintenance failure for at least 1 Antiarrythmic Drugs;
    3. Diagnosis of Atrial Fibrilation on resting eletrocardiogram and/or 24h Holter.

Exclusion Criteria:

  • Prior Atrial Fibrillation ablation;
  • Atrial Fibrillation permanent and/or persistent;
  • Left atrial size > 55 mm;
  • Mechanical prothetic mitral valve replacement;
  • Presence of atrial thrombus;
  • Cardiac invasive procedure < 90 days;
  • Cerebral embolism < 6 months;
  • Hypertrophic cardiomyopathy;
  • Contraindications to antiocoagulation and cerebral MRI.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mauricio I Scanavacca, MD, PhD +55112661-5341 mauricio.scanavacca@gmail.com
Contact: Luiz Claudio B Martins, MD +5513974189969 lcardio@uol.com.br
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04023461
Other Study ID Numbers  ICMJE 4471/16/137
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mauricio Ibrahim Scanavacca, University of Sao Paulo General Hospital
Study Sponsor  ICMJE University of Sao Paulo General Hospital
Collaborators  ICMJE Medtronic
Investigators  ICMJE
Principal Investigator: Mauricio I Scanavacca, MD, PhD Arrythmia Clinical Unit Director
PRS Account University of Sao Paulo General Hospital
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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