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Atrial FibrillationNCT02213731

Cryoballoon Ablation for Early Persistent Atrial Fibrillation (Cryo4 Persistent AF)

A study testing Holter monitoring in people with Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 14 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this clinical study is to assess the single procedure outcomes of using cryoballoon ablation without additional empirical lesions and/or complex fractionated electrogram (CFE) ablations for patients with early persistent atrial fibrillation (<1 year from first diagnosis of persistent AF). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Atrial Fibrillation
What is being tested?
Holter monitoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
14 sitesin 3 countries
Study dates
8 Dec 2014to 12 Sep 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with documented symptomatic persistent AF refractory or intolerant to at least 1 class I or III antiarrhythmic medication. Persistent AF defined as:
  • Episode lasting longer than 7 days, but less than 1 year documented by consecutive ECG recordings of 100% AF greater than 7 days apart OR
  • Episode requiring electrical or pharmacological cardioversion after 48 hours of AF documented by continuous recording
  • Date of first diagnosis of persistent AF within the last 12 months preceding the consent date
  • Age between 18 and 75 years
  • Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's (or their legally authorized representative or guardian) voluntary agreement to participate in a particular clinical study) to participate in this clinical study

Who cannot join

  • Long-standing persistent AF (has lasted for ≥1 year)
  • Current diagnosis of paroxysmal AF
  • Anteroposterior LA diameter > 5.0 cm by TTE
  • Current intracardiac thrombus
  • Presence of one or more pulmonary vein stents
  • Presence of any pre-existing pulmonary vein stenosis
Show all 25Show fewer
  • Primary pulmonary hypertension
  • NYHA class IV congestive heart failure and/or documented left ventricular ejection fraction (LVEF) < 40% measure by acceptable cardiac testing (e.g. TTE)
  • Hypertrophic cardiomyopathy
  • Previous LA ablation or surgery
  • Unstable angina
  • Presence of any cardiac valve prosthesis
  • Thrombocytosis, thrombocytopenia
  • Any condition contraindicating chronic anticoagulation
  • Any cardiac surgery, myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3 month interval preceding the consent date
  • Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the consent date
  • Cryoglobulinemia
  • Presence or likely implant of a permanent pacemaker, biventricular pacemaker, loop recorder, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) within 12 months
  • Uncontrolled hyperthyroidism
  • Any woman known to be pregnant or breastfeeding
  • Active systemic infection
  • Subject is employed by Medtronic or by the department of any of the investigators or is a close relative of any of the investigators
  • Life expectancy ≤ 1 year
  • Currently enrolled or plans to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent studies is allowed when documented pre-approval is obtained from the Medtronic study manager
  • Exclusion criteria as per local laws (for France, this includes, but is not limited to: incompetent adults or patients that are not affiliated to the French social security system)

Trial locations and contacts

14 sites in 3 countries.

14 sites in 3 countries

Germany8 sites

  • Herz- und Diabeteszentrum NRW

    Bad Oeynhausen

  • Charite - Universitaetsmedizin

    Berlin, 10117

  • Krankenhaus Porz am Rhein

    Cologne

  • St. Vinzenz-Hospital

    Cologne

  • Cardioangiologisches Centrum Bethanien

    Frankfurt

  • Asklepios Klinik St. Georg

    Hamburg

  • Klinikum Nürnberg Süd

    Nuremberg

  • Uniklinik Ulm

    Ulm

Other trials in Germany

France5 sites

  • Hôpital Henri Mondor

    Créteil

  • CHU de Grenoble

    Grenoble

  • CHU de la Timone

    Marseille

  • CHU - Hôpitaux de Rouen

    Rouen

  • Clinique Pasteur

    Toulouse

Other trials in France

Greece1 site

  • Henry Dunant Hospital Center

    Athens, 11526

Other trials in Greece

About this study

Official title: Cryoballoon Ablation for Early Persistent Atrial Fibrillation

The purpose of this clinical study is to assess the single procedure outcomes of using cryoballoon ablation without additional empirical lesions and/or complex fractionated electrogram (CFE) ablations for patients with early persistent atrial fibrillation (<1 year from first diagnosis of persistent AF).

Being tested
Holter monitoring
Keywords
Atrial Fibrillation, Persistent Atrial Fibrillation, Cryoablation, Cryoballoon, Pulmonary Vein Isolation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Holter monitoringOther

    Subjects will wear holter monitors at baseline, 6 months and 12 months.

Study groups in NCT02213731
Study groupRoleWhat they receive
Cryoballoon ablationOtherSubjects will wear holter monitors at baseline, 6 months and 12 months
Receives: Other: Holter monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Single procedure success of cryoballoon ablation on patients with early persistent AF

    12 month success will be defined as absence of adjudicated AF/atrial flutter/atrial tachyarrhythmias >/= 30 seconds in duration from the end of the 90 day blanking period of the cryoballoon ablation procedure to at least 12 months after the cryoballoon ablation procedure. Only Arctic Front Advance catheters may be used to achieve the single procedure success and no additional empirical lesions and/or complex fractionated electrogram (CFE) ablations may be made. Additionally, subjects must not require any other intervention for AF following the index procedure. Right atrial flutter ablations and pharmacological and/or electrical cardioversion can be performed within the 90 day blanking period.

    Measured: 12 months

Secondary outcomes (6)

  1. Acute procedural success of cryoballoon ablation on patients with early persistent AF

    Acute procedural success is defined as:

    • Only Arctic Front Advance catheters used to achieve procedure success AND
    • All targeted pulmonary veins were isolated (minimally assessed for entrance block and, where assessable, exit block) AND
    • Sinus rhythm is restored at the end of the ablation procedure (with or without cardioversion)

    Measured: Post-procedure

  2. Success of cryoballoon ablation on patients with early persistent AF (allowing for multiple procedures)

    12 month success will be defined as absence of adjudicated AF/atrial flutter/atrial tachyarrhythmias >/= 30 seconds in duration from the end of the 90 day blanking period of the cryoballoon ablation procedure to at least 12 months after the cryoballoon ablation procedure. Only Arctic Front Advance catheters may be used to achieve multiple procedure success and no additional empirical lesions and/or complex fractionated electrogram (CFE) ablations may be made. Additionally, subjects must not require any other intervention for AF. Right atrial flutter ablations and pharmacological and/or electrical cardioversion can be performed within the 90 day blanking period.

    Measured: 12 months

  3. Sinus rhythm restoration being followed by chronic prevention of AF recurrence

    Measured: 12 months

  4. Use of class I and class III antiarrhythmic drugs

    Measured: 12 months

  5. Changes in quality of life measurements between baseline, 6 months and 12 months after procedure

    Measured: Baseline, 6 months, 12 months

  6. Adverse events required to be collected during the study

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2014 (estimated)
  2. Study start8 Dec 2014
  3. Primary completion22 Jun 2017
  4. Study completion12 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02213731
Sponsor's protocol ID
Cryo4 Persistent AF
Status last verified
Feb 2025
First submitted
31 Jul 2014
Last updated
13 Feb 2025
Results posted
No
Data monitoring committee
No

Publications

  • Boveda S, Metzner A, Nguyen DQ, Chun KRJ, Goehl K, Noelker G, Deharo JC, Andrikopoulos G, Dahme T, Lellouche N, Defaye P. Single-Procedure Outcomes and Quality-of-Life Improvement 12 Months Post-Cryoballoon Ablation in Persistent Atrial Fibrillation: Results From the Multicenter CRYO4PERSISTENT AF Trial. JACC Clin Electrophysiol. 2018 Nov;4(11):1440-1447. doi: 10.1016/j.jacep.2018.07.007. Epub 2018 Aug 25.

    PubMed 30466850

Questions about this trial

What is this clinical trial studying?

A study testing Holter monitoring in people with Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 14 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Germany, France, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Single procedure success of cryoballoon ablation on patients with early persistent AF (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02213731, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.

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