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Trial record 18 of 1194 for:    adenosine

Adenosine to Assess Complete Conduction Block During Catheter Ablation of Paroxysmal Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT03032965
Recruitment Status : Completed
First Posted : January 26, 2017
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Hamid Ghanbari, University of Michigan

Tracking Information
First Submitted Date  ICMJE September 1, 2016
First Posted Date  ICMJE January 26, 2017
Results First Submitted Date  ICMJE September 28, 2017
Results First Posted Date  ICMJE December 13, 2017
Last Update Posted Date December 13, 2017
Study Start Date  ICMJE October 2011
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2017)
Freedom From Any Atrial Arrhythmias [ Time Frame: 2- 14 months after Ablation procedure ]
Primary endpoint of the study will be number of participants who are free from any atrial arrhythmias after a single ablation procedure in the absence of antiarrhythmic drug therapy
Original Primary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
Freedom From Any Atrial Arrhythmias [ Time Frame: 6 months after Ablation procedure ]
Primary endpoint of the study will be freedom from any atrial arrhythmias after a single ablation procedure in the absence of antiarrhythmic drug therapy
Change History Complete list of historical versions of study NCT03032965 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2017)
  • Number of Subjects Who Need Repeat Ablations [ Time Frame: date of ablation to 6 months after procedure ]
    Number of participants who had one or more repeat ablation procedures due to documented recurrence of Symptomatic AF or atrial flutter/tachycardia.
  • Number of Subjects With AF or Atrial Flutter/Tachycardia Occurring During the First Three Months Post Ablation [ Time Frame: first three months post ablation ]
  • Number of Pulmonary Veins That Recovered Conduction During Repeat Ablation Procedures in Both Groups [ Time Frame: post-procedure (6 months) ]
    Prevalence of recovery of conduction into pulmonary veins during repeat ablation procedures in both groups. This is determined by surgeon assessment using a circular mapping catheter to identify recovery of conduction into the pulmonary veins.
  • Incidence of Stroke [ Time Frame: peri-procedural (0 to 30 days after procedure) ]
    Number of subjects who develop stroke within 30 days after procedure.
  • Incidence of Pulmonary Vein Stenosis [ Time Frame: 6 months post-procedure ]
    Number of subjects who develop Symptomatic pulmonary vein stenosis
  • Incidence of Cardiac Perforation [ Time Frame: within 24 hours ]
    Number of subjects who develop perforation of heart during ablation
  • Incidence of Atrio-esophageal Fistula [ Time Frame: within 4 weeks ]
    Number of subjects who develop connection between heart and the esophagus
  • Incidence of Death [ Time Frame: with 90 days of the procedure ]
    Number of deaths within 90 days of the procedure.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
  • Number of repeat ablation procedures due to documented recurrence of Symptomatic AF or atrial flutter/tachycardia [ Time Frame: date of ablation to 6 months after procedure ]
    Number of subjects who need repeat ablations
  • Number of subjects who need repeat ablations.with AF or atrial flutter/tachycardia occurring during the first three months post ablation [ Time Frame: Proportion of patients with AF or atrial flutter/tachycardia occurring during the first three months post ablation ]
    Proportion of patients with AF or atrial flutter/tachycardia occurring during the first three months post ablation,
  • prevalence of recovery of conduction into Pulmonary veins during repeat ablation procedures in both groups [ Time Frame: post-procedure (6 months) ]
    prevalence of recovery of conduction into Pulmonary veins during repeat ablation procedures in both groups
  • Incidence of Stroke [ Time Frame: peri-procedural (0 to 30 days after procedure) ]
    Number of subjects who develop stroke within 30 days after procedure.
  • Incidence of Pulmonary Vein Stenosis [ Time Frame: 6 months post-procedure ]
    Number of subjects who develop Symptomatic pulmonary vein stenosis
  • Incidence of Cardiac Perforation [ Time Frame: within 24 hours ]
    Number of subjects who develop perforation of heart during ablation
  • Incidence of Atrio-esophageal Fistula [ Time Frame: within 4 weeks ]
    Number of subjects who develop connection between heart and the esophagus
  • Incidence of Death [ Time Frame: with 90 days of the procedure ]
    Number of deaths within 90 days of the procedure.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adenosine to Assess Complete Conduction Block During Catheter Ablation of Paroxysmal Atrial Fibrillation
Official Title  ICMJE Adenosine Study in Paroxysmal Atrial Fibrillation
Brief Summary The purpose of this study is to determine if additional ablation during the first procedure as the result of the ability to medically induce quiet atrial arrhythmias will improve clinical outcome in patients with atrial fibrillation thus decreasing the need for additional ablation procedures.
Detailed Description

Hypothesis:

  1. Adenosine reveals incomplete conduction block due to partial tissue injury/stunning during catheter ablation of atrial fibrillation.
  2. Identification of incomplete conduction block by adenosine improves clinical outcomes including an increase in efficacy and a decrease in need for repeat procedures after catheter ablation of atrial fibrillation.

Objectives:

  1. In patients with paroxysmal Atrial Fibrillation (AF), the prevalence of Pulmonary Vein (PV) reconnection during adenosine infusion after complete PV isolation using conventional techniques will be determined.
  2. Patients will be randomized to further ablation to achieve complete isolation during adenosine infusion vs to no further ablation.
  3. Primary endpoint of the study will be freedom from any atrial arrhythmias 6 months after a single ablation procedure in the absence of antiarrhythmic drug therapy.
  4. Secondary endpoints will include number of repeat ablation procedures because of documented recurrence of symptomatic AF or atrial flutter/tachycardia, outcome after 2 ablation procedures; Proportion of patients with AF or atrial flutter/tachycardia occuring during the first three months post ablation, prevalence of recovery of conduction into PVs during repeat ablation procedures in both groups, procedure duration, and incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, atrio-esophageal fistulae, and death.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE
  • Drug: Adenosine

    Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.

    Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.

  • Drug: Isoproterenol
    Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol.
    Other Name: Isuprel
Study Arms  ICMJE
  • Experimental: Adenosine and Isoproterenol
    Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.
    Interventions:
    • Drug: Adenosine
    • Drug: Isoproterenol
  • Isoproterenol
    This group will not receive adenosine during the procedure.
    Intervention: Drug: Isoproterenol
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 Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2017)
131
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients >18 and <75 who are able to give informed consent undergoing atrial fibrillation ablation procedure.
  2. Paroxysmal Atrial fibrillation lasting = 7 days which is self-terminating. It is considered recurrent if two or more episodes occur.
  3. Failure or unwilling to take class I or III anti-arrhythmic drugs

Exclusion Criteria:

  1. History of asthma
  2. Patients with severe coronary artery disease, stable/unstable angina, or ongoing myocardial ischemia
  3. Previous cardiac surgery ( excluding CABG and mitral valve surgery)
  4. Symptomatic congestive heart failure including but not limited to NYHA III/IV and/or documented ejection fraction <40% measured by acceptable cardiac testing,
  5. Left atrial diameter >55mm
  6. Moderate to severe mitral or aortic valve disease
  7. Myocardial infarction within three months of enrollment
  8. Congenital heart disease where it increases the risk of an ablative procedure
  9. Prior ASD/PFO closure with a device using a percutaneous approach
  10. Hypertrophic cardiomyopathy (LV wall thickness >1.5mm)
  11. Pulmonary Hypertension (mean or systolic PA pressure> 50mmHg on Doppler echocardiography
  12. Any prior ablation of atrial fibrillation
  13. Enrollment in any other arrhythmia protocol
  14. Any ventricular arrhythmia being treated where the arrhythmia or management may interfere with this study
  15. Active infection or sepsis
  16. Any history of cerebrovascular disease including stroke or TIAs
  17. Pregnancy or lactation
  18. Left atrial thrombus at the time of ablation
  19. Untreatable allergy to contrast media
  20. Any diagnosis of atrial fibrillation secondary to electrolyte disturbance, thyroid disease, or any other reversible or non-cardiovascular causes
  21. History of blood clotting(bleeding or thrombotic) abnormalities
  22. Known sensitivities to heparin or warfarin
  23. Severe COPD (defined as FEV1 <1)
  24. Severe comorbidity or poor general physical/mental health that, in opinion of the investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectancy)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03032965
Other Study ID Numbers  ICMJE HUM00048922
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hamid Ghanbari, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hamid Ghanbari, MD University of Michigan
PRS Account University of Michigan
Verification Date November 2017

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