CompletedNot Applicable

Cryoballoon vs. Rhythmia Guided Ablation for Recurrent AFib

United States9 participantsStarted 2018-11-27

Plain-language summary

The purpose of this research is to evaluate whether cryoballoon ablation vs. radiofrequency ablation guided by high-fidelity mapping (Rhythmia) is the best treatment strategy to perform repeat ablation for recurrent atrial fibrillation after previously having undergone cryoballoon ablation.

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Individuals with paroxysmal or persistent AF undergoing repeat AF ablation as per recent HRS guidelines and standard practice; * Individuals in whom the initial ablation approach was cryoballoon PVI at the enrolling institution more than 3 month or more prior to the anticipated repeat ablation; * Age ≥ 18 years. Exclusion Criteria: * Individuals with recurrent AF who previously underwent RF-based PVI; * Individuals with known contraindications to ablation including permanent atrial fibrillation or intolerance of anticoagulation; * Individuals unable or not willing to complete follow-up visits and examination for the duration of the study; * Individuals without access to smartphone or tablet compatible with the monitoring system; * Prior valve surgery or surgical AF ablation; * Individuals with mental or physical limitations precluding informed consent; * Individuals currently enrolled in another investigational study or registry; * Women of childbearing potential who are, or plan to become, pregnant during the time of the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PrimaryCryoballoon vs. Rhythmia Guided Ablation for Recurrent AFib

Timeframe: Six months

Trial details

NCT IDNCT03811795

SponsorValley Health System

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-26

View on ClinicalTrials.gov More Atrial Fibrillation trials

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.