NCT02925624

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

June 7, 2021

Status Verified

June 1, 2021

Enrollment Period

5.3 years

First QC Date

September 29, 2016

Last Update Submit

June 4, 2021

Conditions

Atrial Fibrillation

Keywords

ablation indexpulmonary vein isolationimplantable loop recorder

Outcome Measures

Primary Outcomes (2)

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

    Continuous monitoring (24 hours loop recording)

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

    Continuous monitoring (24 hours loop recording)

Secondary Outcomes (10)

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

    3 months to 3 years

  • Evaluating progression of scarring at redo procedure assessed by voltage mapping

    3 months to 3 years

  • Incidence of adverse events related to ablation

    Baseline to 3 years

  • Freedom from stroke/transient ischemic attack (TIA)

    Baseline to 3 years

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

    1 month to 3 years

  • +5 more secondary outcomes

Other Outcomes (23)

  • Clinical characteristic assessed by height

    At baseline

  • Clinical characteristic assessed by weight

    At baseline

  • Clinical characteristic assessed by age

    At baseline

  • +20 more other outcomes

Study Arms (1)

CLOSE guided PVI and insertable cardiac monitor

EXPERIMENTAL
Procedure: Pulmonary vein isolation

Interventions

Pulmonary vein isolationPROCEDURE
CLOSE guided PVI and insertable cardiac monitor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZ Sint-Jan Hospital

Bruges, 8000, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 31707159DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mattias Duytschaever, MD, PhD

    Department of Cardiology, AZ Sint-Jan Hospital Bruges, Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor

Study Record Dates

First Submitted

September 29, 2016

First Posted

October 6, 2016

Study Start

December 1, 2015

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

June 7, 2021

Record last verified: 2021-06

Locations

BE(1)