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Comparison of Recurrence of Atrial Fibrillation Post Cryoballon Ablation During the 90-day Blanking Period-with and Without Anti-arrhythmic Drug Therapy

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: NCT02913014
Recruitment Status : Unknown
Verified September 2018 by Sultan Siddique, MD, Prisma Health-Midlands.
Recruitment status was:  Recruiting
First Posted : September 23, 2016
Last Update Posted : September 28, 2018
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Sultan Siddique, MD, Prisma Health-Midlands

Brief Summary:
This study is being done to find out if patients taking Anti Arrhythmia Drugs (AADs) after cryoballoon ablation for atrial fibrillation, compared to patients who do not take Anti- Arrhythmic Drugs after an ablation affect Atrial Fibrillation from coming back. The study will also look at the side effects of the AADs.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Other: No AAD post Ablation. Not Applicable

Detailed Description:
Pulmonary vein isolation (PVI) is a cornerstone ablation strategy used in the management of paroxysmal atrial fibrillation (PAF), and it is a class IA indication for anti-arrhythmic drug (AAD) refractory symptomatic PAF. However, the consensus statements are vague about the utility of AAD management during the 90-day blanking window post-PVI. Moreover, there is no specific guidance to cryoballoon users on the usage of AADs during the 90-day blanking period that exists anywhere in the published literature. Simply, these studies have not been conducted with the cryoballoon procedure.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Monitoring Safety and Recurrence of Paroxysmal Atrial Fibrillation After 1st Cryo-balloon Ablation With and Without Antiarrhythmic Drug Therapy During the 90-day Blanking Period - Examined With Adverse Event Monitoring and Cardiovascular Implantable Electronic Devices (CIEDs)
Actual Study Start Date : June 28, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm 1- No AAD post Ablation
Subjects will not resume their Anti Arrhythmic Drugs after cryoballoon-ablation for paroxysmal atrial fibrillation.
Other: No AAD post Ablation.
Subjects will not resume their pre-ablation anti-arrhythmic medications during the 90 following cryo ablation for Atrial Fibrillation
Other Name: No AAD

No Intervention: Arm 2-Resume AAD post Ablation
Subjects will resume their pre-ablation Anti Arrhythmic Drugs after cryoballoon-ablation for paroxysmal atrial fibrillation, during the 90 day blanking period following the ablation.



Primary Outcome Measures :
  1. Compare recurrence, recurrence rate, burden of atrial fibrillation post ablation between the two groups. [ Time Frame: 12 months ]

    Rhythm status through implantable loop recorder (or pacemaker with functioning atrial lead) at 3 month, 6 month, 12 month compared between two treatment groups, including:

    A) AF burden (Average amount of time in AF per day) B) AF recurrence rate (Frequency of AF, occurrences per day) C) Time to AF recurrence


  2. Symptom Assessments [ Time Frame: 12 months ]
    Symptom assessments by clinical follow up and phone calls, including symptom severity score using the Severity of Atrial Fibrillation Scale between the two groups.

  3. Adverse Events Assessments [ Time Frame: 12 months ]
    Ongoing assessment of adverse events in both arms of the study, including AADs side effects in 90-day blanking period.


Secondary Outcome Measures :
  1. The cost of AADs during the 90-day blanking period. [ Time Frame: 12 months ]
    The cost of AADs during the 90-day blanking period.

  2. Assess the rate of hospitalizations, emergency room visits, and unscheduled cardiology visits for the treatment of AF between the two groups [ Time Frame: 12 months ]
    A) Event during the 90-day blanking period will be assessed for AAD related and unrelated adverse events that caused the cardiac related visit

  3. The differential usage of anticoagulation therapy between two arms. [ Time Frame: 12 months ]
    The differential usage of anticoagulation therapy between two arms.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Drug refractory and recurrent Paroxysmal Atrial Fibrillation
  • The subject meets medical criteria for cryoballoon ablation to treat Paroxysmal AF
  • Age 18 to 80 years
  • The subject has a Cardiovascular Implantable Electronic Device (CIED) that captures AF episodes, such as an implantable loop recorder, pacemaker, or implantable cardioverter defibrillator (ICD) with a properly functioning atrial lead.

Exclusion Criteria:

  • Use of any Anti- Arrhythmic Drugs for ventricular arrhythmias
  • Ejection Fraction (EF)<45%
  • Prior A. Fib. ablation
  • Pregnant women

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): NCT02913014


Contacts
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Contact: Evelyn J Kennedy, MSN 803-434-3682 evelyn.kennedy@palmettohealth.org
Contact: Michael Haney, ME 803-434-7056 michael.haney@palmettohealth.org

Locations
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United States, South Carolina
Palmetto Health Recruiting
Columbia, South Carolina, United States, 29203
Sponsors and Collaborators
Prisma Health-Midlands
Medtronic
Investigators
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Principal Investigator: Sultan M Siddique, MD Prisma Health-Midlands
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Responsible Party: Sultan Siddique, MD, MD, FACC, FHRS, Cardiovascular Disease, ABIM Clinical Cardiac Electrophysiology, Prisma Health-Midlands
ClinicalTrials.gov Identifier: NCT02913014    
Other Study ID Numbers: Pro00055684
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sultan Siddique, MD, Prisma Health-Midlands:
Antiarrhythmic Agents
Catheter Ablation, electric
Cardiac Arrhythmias
Anti-Arrhythmia Drugs
Additional relevant MeSH terms:
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Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes