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Comparison of PVI Plus Catheter Ablation or PVI Alone for the Treatment of AFib for Patients With Paroxysmal Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03115554
Recruitment Status : Terminated (Patients did not want to be randomized in their procedure.)
First Posted : April 14, 2017
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Jasbir Sra, Aurora Health Care

Brief Summary:
There is a need to compare the efficacy of PVI versus PVI plus catheter ablation, which includes ablation of complex fractionated atrial electrograms (CFAE) and linear lesions in the same procedure. If it is found that the PVI alone is as effective as PVI plus catheter ablation of CFAE and linear lesions, it may reduce the need for catheter ablation.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: PVI Plus Catheter Ablation Procedure: PVI Alone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Pulmonary Vein Isolation Plus Additional Catheter Ablation or Pulmonary Vein Isolation Alone for the Treatment of Atrial Fibrillation for Patients With Paroxysmal Atrial Fibrillation: A Prospective, Randomized Study
Actual Study Start Date : April 6, 2017
Actual Primary Completion Date : August 3, 2017
Actual Study Completion Date : August 3, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: PVI Plus Catheter Ablation
Patients with sustained AF following PVI will receive additional linear or focal intracardiac catheter ablation for AF.
Procedure: PVI Plus Catheter Ablation
Patients with sustained AF following PVI will receive additional linear or focal intracardiac catheter ablation for AF.

Active Comparator: PVI Alone
Patients with sustained AF following PVI will not receive additional linear or focal intracardiac catheter ablation for AF.
Procedure: PVI Alone
Patients with sustained AF following PVI will not receive additional linear or focal intracardiac catheter ablation for AF.




Primary Outcome Measures :
  1. Time to recurrence [ Time Frame: 12 months ]
    Any atrial fibrillation/atrial tachycardia/atrial flutter following the blanking period.


Secondary Outcome Measures :
  1. Time to recurrence following intervention [ Time Frame: 12 months post intervention ]
    Time to recurrence following intervention



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

(Step 1 - Registration)

  • The subject is 18 years of age or older
  • Left atrium < 6.0 cm (Trans Thoracic Echo - TTE - parasternal 4 chamber view
  • performed within 6 months)
  • Documentation of AF that terminates spontaneously or with intervention within 7 days of onset (PAF) Failed or refractory to one AAD (class I and/or III)
  • Provided written informed consent
  • Be eligible for an AF ablation procedure for Paroxysmal AF

(Step 2 - Randomization)

  • Sustained AF following PVI with ability to receive additional linear or focal intracardiac catheter ablation

Exclusion Criteria:

(Step 1 - Registration)

  • Pregnant or planning to become pregnant during study
  • Co-morbid medical conditions that limit one-year life expectancy
  • Previous cardiac surgery
  • Patients who have active infection or sepsis
  • Patients with esophageal ulcers strictures and varices
  • Patients who are contraindicated for anticoagulants such as heparin and warfarin
  • Patients who are being treated for ventricular arrhythmias
  • Patients who have had a previous left atrial catheter ablation for AF (does not
  • include ablation for AFL or other supraventricular arrhythmias)
  • Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment
  • Not competent to legally represent him or herself (e.g., requires a guardian or
  • caretaker as a legal representative)

(Step 2 Randomization)

  • Not able to receive additional linear or focal intracardiac catheter ablation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115554


Locations
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United States, Wisconsin
Aurora Health Care
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Aurora Health Care
Investigators
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Principal Investigator: Jasbir Sra, MD Aurora Health Care
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Responsible Party: Jasbir Sra, Director/Physician Electrophysiology, Aurora Health Care
ClinicalTrials.gov Identifier: NCT03115554    
Other Study ID Numbers: 16-74
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes