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Completed

NCT Number: NCT02913014

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Palmetto Health

Columbia, South Carolina, 29203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No AAD post Ablation.

Other

Subjects will not resume their pre-ablation anti-arrhythmic medications during the 90 following cryo ablation for Atrial Fibrillation

Other names: No AAD

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Prisma Health-Midlands

Other

Collaborators

  • Medtronic

Registry information

Official study 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)

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 23, 2016
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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