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Freeze or pills? new study battles persistent AF

NCT ID NCT03716934

Disease control Sponsor: Hospital San Carlos, Madrid 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study compared two treatments for persistent atrial fibrillation (an irregular heartbeat): cryoablation (freezing tiny areas of heart tissue) and antiarrhythmic drugs. 196 patients were randomly assigned to one treatment and monitored for over a year. The goal was to see which approach better prevents heart rhythm problems and major complications like stroke or heart attack.

What this could mean

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

Active substance
cryoablation (freezing heart tissue) or antiarrhythmic drugs
What this could lead to
If cryoablation proves safer or more effective than drugs, it could become a preferred treatment for persistent atrial fibrillation, reducing symptoms and complications.
What could go wrong
This is a completed Phase 4 trial with 196 patients, so results are limited. Cryoablation carries risks like stroke, heart damage, or need for a pacemaker, and may not work for everyone.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

196 people

The number who actually took part.

Started

Jun 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 75 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: * Patients with recurrent persistent atrial fibrilation Exclusion Criteria: * Patients with atrial fibrilation for more than one year at baseline * Atrial fibrilation prior ablation * Age\> 75 years or \<18 years * Hyperthyroidism * Hypertrophic cardiomyopathy * Severe valvular disease (stenosis or regurgitation) * Carriers of cardiac valves * Anteroposterior diameter of left atrium\> 50 mm (left parasternal long axis) * Contraindications for anticoagulation * Left atrial thrombus * Anemia * Active infection * Pregnancy * Atrial fibrilation secondary to transient, avoidable or correctable causes (hyperthyroidism, pneumonia, pulmonary embolism, drugs, hydroelectrolytic alterations ...) * Life expectancy of less than 24 months * Participation in another non-purely observational study * Patients unable to understand treatment and / or study and / or providing adequate informed consent * Any condition, that in the opinion of the physician responsible for the patient, contraindicates any of the treatments of the study * Microalbuminemia

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Conditions

The condition(s) this trial relates to.

atrial fibrillation persistent 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

  • Fundacion para Investigación Biomedica Hospital Clinico San Carlos

    Madrid, Madrid, 28040, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.