NCT02913014

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 23, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

June 28, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

October 31, 2024

Status Verified

October 1, 2024

Enrollment Period

3.5 years

First QC Date

August 31, 2016

Last Update Submit

October 29, 2024

Conditions

Atrial Fibrillation

Keywords

Antiarrhythmic AgentsCatheter Ablation, electricCardiac ArrhythmiasAnti-Arrhythmia Drugs

Outcome Measures

Primary Outcomes (3)

  • Compare recurrence, recurrence rate, burden of atrial fibrillation post ablation between the two groups.

    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

    12 months

  • Symptom Assessments

    Symptom assessments by clinical follow up and phone calls, including symptom severity score using the Severity of Atrial Fibrillation Scale between the two groups.

    12 months

  • Adverse Events Assessments

    Ongoing assessment of adverse events in both arms of the study, including AADs side effects in 90-day blanking period.

    12 months

Secondary Outcomes (3)

  • The cost of AADs during the 90-day blanking period.

    12 months

  • Assess the rate of hospitalizations, emergency room visits, and unscheduled cardiology visits for the treatment of AF between the two groups

    12 months

  • The differential usage of anticoagulation therapy between two arms.

    12 months

Study Arms (2)

Arm 1- No AAD post Ablation

ACTIVE COMPARATOR

Subjects will not resume their Anti Arrhythmic Drugs after cryoballoon-ablation for paroxysmal atrial fibrillation.

Other: No AAD post Ablation.

Arm 2-Resume AAD post Ablation

NO INTERVENTION

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.

Interventions

No AAD post Ablation.OTHER

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

Also known as: No AAD
Arm 1- No AAD post Ablation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Palmetto Health

Columbia, South Carolina, 29203, United States

Location

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sultan M Siddique, MD

    Prisma Health-Midlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2016

First Posted

September 23, 2016

Study Start

June 28, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

October 31, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)