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Which ablation works best for AFib that returns? small study compares two techniques

NCT ID NCT03811795

Disease control Sponsor: Valley Health System Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 9 people with atrial fibrillation (AFib) that came back after an initial cryoballoon ablation. It compared two repeat ablation methods: another cryoballoon procedure versus radiofrequency ablation guided by a high-fidelity mapping system (Rhythmia). Participants used a smartphone-based ECG monitor to track their heart rhythm daily for 6 months. The goal was to see which method better prevents AFib from returning.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cryoballoon ablation and radiofrequency ablation guided by high-fidelity mapping (Rhythmia)
What this could lead to
If this trial succeeds, it could help doctors choose the best repeat ablation method for people with atrial fibrillation that comes back after a first cryoballoon procedure.
What could go wrong
This is a very small, completed study with only 9 participants, so results may not apply to everyone. It does not test a new drug or device, just compares existing techniques.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

9 people

The number who actually took part.

Started

Nov 2018

Finished

Apr 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation

Contacts and locations

Locations

  • Iowa Heart Center

    West Des Moines, Iowa, 50266, United States

  • Peace Health

    Springfield, Oregon, 97477, United States

  • The Valley Hospital

    Paramus, New Jersey, 07652, United States

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