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Atrial FibrillationNCT02925624

CLOSE to CURE Study

A study testing Pulmonary vein isolation in people with Atrial Fibrillation, run by AZ Sint-Jan AV at 1 site in Belgium.

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

Title: CLOSE-guided pulmonary vein isolation (PVI) as Cure for Paroxysmal Atrial Fibrillation ('CLOSE to CURE' study) Design: This is a prospective, observational, single-center, unblinded, clinical 3-year study. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Pulmonary vein isolation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteBelgium
Study dates
Dec 2015to 31 Mar 2021
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with symptomatic paroxysmal AF (history of self-terminating AF within 7 days or history of self-terminating AF with 1 or more cardioversions within 48 hours after onset), meeting following criteria at the out-patient clinic:
  • patient has at least 3 AF episodes in the last 3 months prior to the visit
  • AF episodes are symptomatic, and patient is drug-resistant (at least one class IC or III), or drug-intolerant (palpitations, fatigue, dyspnea, cardiomyopathy,…)
  • no advanced structural heart disease
  • patient has a CHA2DS2-VASc score of 0, 1, 2, 3 or 4
  • Signed Patient Informed Consent Form.
  • Age 18 years or older.
  • Able and willing to comply with all follow-up testing and requirements.

Who cannot join

  • Persistent atrial fibrillation (history of AF>7days or history of cardioversion > 48h of AF)
  • Previous ablation for AF
  • LA antero-posterior diameter > 50 mm (parasternal long axis view , PLAX)
  • LVEF < 35% (ejection fraction)
  • AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
  • Coronary artery bypass grafting (CABG) procedure within the last three months
Show all 19Show fewer
  • Awaiting cardiac transplantation or other cardiac surgery
  • Documented left atrial thrombus on imaging
  • Diagnosed atrial myxoma
  • Women who are pregnant or breastfeeding
  • Acute illness or active systemic infection or sepsis
  • Unstable angina
  • Uncontrolled heart failure
  • Myocardial infarction within the previous two months
  • History of blood clotting or bleeding abnormalities
  • Contraindication to anticoagulation therapy (ie, heparin or warfarin)
  • Life expectancy less than 12 months
  • Enrollment in any other study evaluating another device or drug
  • Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • AZ Sint-Jan Hospital

    Bruges, 8000

Other trials in Belgium

About this study

Official title: 'CLOSE'-Guided Pulmonary Vein Isolation as Cure for Paroxysmal Atrial Fibrillation?

Title: CLOSE-guided pulmonary vein isolation (PVI) as Cure for Paroxysmal Atrial Fibrillation ('CLOSE to CURE' study)

Design: This is a prospective, observational, single-center, unblinded, clinical 3-year study.

Read more

Background: In a population of paroxysmal atrial fibrillation (AF) 'CLOSE'-guided PVI, a new approach to obtain single-procedure durable PVI, has been shown to virtually eliminate recurrence of AF at 1 year follow-up with repetitive but discontinuous Holter monitoring.

Objectives: (1) To objectively compare atrial tachyarrhythmia (ATA) burden before and after 'CLOSE'-guided based PVI using continuous monitoring. (2) To assess ATA burden using continuous monitoring up to 3 years after ablation. (3) To identify baseline structural and electrical properties of the atria or procedural characteristics that predict 1-year and 3-year outcome.

Enrollment: Up to 100 subjects will be enrolled in this observational, prospective study.

Clinical Sites: 1 site.

Subject Population: Eligible patients are patients with paroxysmal high-burden AF who are planned for a 'CLOSE'-guided PV isolation. At the time of procedural planning we will ask the patient his/her consent for (1) implantation of a subcutaneous continuous loop recorder (sCLR), (2) a concise electrophysiological study at the time of PVI, (3) a transthoracic echocardiogram at the time of PVI and (4) collection of data during 3 years. Anti-arrhythmic drug treatment (ADT) and oral anticoagulation (OAC) will be given according the updated 2012 European society of Cardiology (ESC) guidelines on AF (Camm et al, European Heart Journal 2012) and the 2012 Heart rhythm society (HRS)/European Heart Rhythm association/European cardiac arrhythmic society Expert Consensus Statement on catheter and surgical ablation of atrial fibrillation (Calkins et al, Heart Rhythm 2012).

Being tested
Pulmonary vein isolation
Keywords
ablation index, pulmonary vein isolation, implantable loop recorder
Medical subject headings
Atrial Fibrillation

What participants receive

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

  • Pulmonary vein isolationProcedure or surgery

Study groups in NCT02925624
Study groupRoleWhat they receive
CLOSE guided PVI and insertable cardiac monitorExperimentalNot described
Receives: Procedure: Pulmonary vein isolation

What is being measured

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

  1. Atrial tachyarrhythmia (ATA) burden before and after 'CLOSE'-guided based PVI

    Measured: Continuous monitoring (24 hours loop recording)

  2. Long-term evaluation of ATA burden after a single 'CLOSE' guided PVI procedure

    Measured: Continuous monitoring (24 hours loop recording)

Secondary outcomes (10)

  1. Evaluating PV re-connection at redo procedure assessed by Lasso catheter

    Visual inspection of electrograms on the Lasso catheter will be performed to verify durable PV isolation or re-connection

    Measured: 3 months to 3 years

  2. Evaluating progression of scarring at redo procedure assessed by voltage mapping

    Point-by-point bipolar voltage mapping will be performed to quantify the amount of low voltage areas in the left atrium (LA)

    Measured: 3 months to 3 years

  3. Incidence of adverse events related to ablation

    Measured: Baseline to 3 years

  4. Freedom from stroke/transient ischemic attack (TIA)

    Measured: Baseline to 3 years

  5. Efficacy of CLOSE protocol ablation assessed by single-procedure freedom from documented atrial tachyarrhythmias (ATA)

    ATA include fibrillation, tachycardia, or flutter

    Measured: 1 month to 3 years

  6. Efficacy of CLOSE protocol ablation assessed by incidence of repeat ablation procedures

    Measured: 1 month to 3 years

  7. Efficacy of CLOSE protocol ablation assessed by multiple-procedure freedom from ATA

    ATA include fibrillation, tachycardia, or flutter

    Measured: 1 month to 3 years

  8. Health economics and outcomes research assessed by quality of life using Short Form (SF-36v2) Health Survey

    Measured: Recruitment to 3 years

  9. Health economics and outcomes research assessed by quality of life using Symptomatic Questionnaire V3

    Measured: Recruitment to 3 years

  10. Health economics and outcomes research assessed by number of hospitalization

    Includes total number of hospitalizations and unscheduled arrhythmia-related health care provider visits

    Measured: Recruitment to 3 years

Timeline

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

  1. First posted6 Oct 2016 (estimated)
  2. Study startDec 2015
  3. Primary completion31 Mar 2021
  4. Study completion31 Mar 2021

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
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02925624
Sponsor's protocol ID
1949
Status last verified
Jun 2021
First submitted
29 Sep 2016
Last updated
7 Jun 2021
Results posted
No
Data monitoring committee
No

Publications

  • Duytschaever M, De Pooter J, Demolder A, El Haddad M, Phlips T, Strisciuglio T, Debonnaire P, Wolf M, Vandekerckhove Y, Knecht S, Tavernier R. Long-term impact of catheter ablation on arrhythmia burden in low-risk patients with paroxysmal atrial fibrillation: The CLOSE to CURE study. Heart Rhythm. 2020 Apr;17(4):535-543. doi: 10.1016/j.hrthm.2019.11.004. Epub 2019 Nov 9.

    PubMed 31707159

Questions about this trial

What is this clinical trial studying?

A study testing Pulmonary vein isolation in people with Atrial Fibrillation, run by AZ Sint-Jan AV at 1 site in Belgium.

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 8 inclusion and 19 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 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. 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?

Atrial tachyarrhythmia (ATA) burden before and after 'CLOSE'-guided based PVI (time frame: Continuous monitoring (24 hours loop recording)). The study lists 2 primary outcomes in all. 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 NCT02925624, 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 7 Jun 2021.

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CLOSE to CURE Study (NCT02925624) | AzTrials