Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

CLOSE to CURE Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02925624
Recruitment Status : Active, not recruiting
First Posted : October 6, 2016
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Mattias Duytschaever, AZ Sint-Jan AV

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).


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Pulmonary vein isolation Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 'CLOSE'-Guided Pulmonary Vein Isolation as Cure for Paroxysmal Atrial Fibrillation?
Study Start Date : December 2015
Actual Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Atrial tachyarrhythmia (ATA) burden before and after 'CLOSE'-guided based PVI [ Time Frame: Continuous monitoring (24 hours loop recording) ]
  2. Long-term evaluation of ATA burden after a single 'CLOSE' guided PVI procedure [ Time Frame: Continuous monitoring (24 hours loop recording) ]

Secondary Outcome Measures :
  1. Evaluating PV re-connection at redo procedure assessed by Lasso catheter [ Time Frame: 3 months to 3 years ]
    Visual inspection of electrograms on the Lasso catheter will be performed to verify durable PV isolation or re-connection

  2. Evaluating progression of scarring at redo procedure assessed by voltage mapping [ Time Frame: 3 months to 3 years ]
    Point-by-point bipolar voltage mapping will be performed to quantify the amount of low voltage areas in the left atrium (LA)

  3. Incidence of adverse events related to ablation [ Time Frame: Baseline to 3 years ]
  4. Freedom from stroke/transient ischemic attack (TIA) [ Time Frame: Baseline to 3 years ]
  5. Efficacy of CLOSE protocol ablation assessed by single-procedure freedom from documented atrial tachyarrhythmias (ATA) [ Time Frame: 1 month to 3 years ]
    ATA include fibrillation, tachycardia, or flutter

  6. Efficacy of CLOSE protocol ablation assessed by incidence of repeat ablation procedures [ Time Frame: 1 month to 3 years ]
  7. Efficacy of CLOSE protocol ablation assessed by multiple-procedure freedom from ATA [ Time Frame: 1 month to 3 years ]
    ATA include fibrillation, tachycardia, or flutter

  8. Health economics and outcomes research assessed by quality of life using Short Form (SF-36v2) Health Survey [ Time Frame: Recruitment to 3 years ]
  9. Health economics and outcomes research assessed by quality of life using Symptomatic Questionnaire V3 [ Time Frame: Recruitment to 3 years ]
  10. Health economics and outcomes research assessed by number of hospitalization [ Time Frame: Recruitment to 3 years ]
    Includes total number of hospitalizations and unscheduled arrhythmia-related health care provider visits


Other Outcome Measures:
  1. Clinical characteristic assessed by height [ Time Frame: At baseline ]
  2. Clinical characteristic assessed by weight [ Time Frame: At baseline ]
  3. Clinical characteristic assessed by age [ Time Frame: At baseline ]
  4. Clinical characteristic assessed by sex [ Time Frame: At baseline ]
  5. Clinical characteristic assessed by congestive heart failure history [ Time Frame: At baseline ]
  6. Clinical characteristic assessed by hypertension history [ Time Frame: At baseline ]
  7. Clinical characteristic assessed by stroke/TIA/Thromboembolism history [ Time Frame: At baseline ]
  8. Clinical characteristic assessed by vascular disease history [ Time Frame: At baseline ]
  9. Clinical characteristic assessed by diabetes mellitus [ Time Frame: At baseline ]
  10. Clinical characteristic assessed by left ventricle ejection fraction (LVEF) [ Time Frame: At baseline ]
  11. Clinical characteristic assessed by structural heart disease [ Time Frame: At baseline ]
  12. Clinical characteristic assessed by endurance measured by amount of training/cycling per week [ Time Frame: At baseline ]
  13. Clinical characteristic assessed by history of implanted devices [ Time Frame: At baseline ]
  14. Clinical characteristic assessed by LA diameter measured by echocardiography [ Time Frame: At baseline ]
  15. Clinical characteristic assessed by LA volume measured by echocardiography [ Time Frame: At baseline ]
  16. Clinical characteristic assessed by cardiovascular medication history [ Time Frame: At baseline ]
  17. Procedure characteristic assessed by procedure time [ Time Frame: At baseline ]
  18. Procedure characteristic assessed by radiofrequency time [ Time Frame: At baseline ]
  19. Procedure characteristic assessed by fluoroscopy time [ Time Frame: At baseline ]
  20. Electrophysiological characteristic assessed by voltage mapping of the LA [ Time Frame: At baseline ]
    Point-by-point bipolar voltage mapping will be performed to quantify the amount of low voltage areas in the LA

  21. Electrophysiological characteristic assessed by atrial refractoriness [ Time Frame: At baseline ]
    This will be done by premature stimulation protocol

  22. Electrophysiological characteristic assessed by conduction velocity [ Time Frame: At baseline ]
    This will be done by premature stimulation protocol

  23. Electrophysiological characteristic assessed by AF inducibility [ Time Frame: At baseline ]
    This will be done by premature stimulation protocol



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Signed Patient Informed Consent Form.
  3. Age 18 years or older.
  4. Able and willing to comply with all follow-up testing and requirements.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925624


Locations
Layout table for location information
Belgium
AZ Sint-Jan Hospital
Bruges, Belgium, 8000
Sponsors and Collaborators
AZ Sint-Jan AV
Investigators
Layout table for investigator information
Principal Investigator: Mattias Duytschaever, MD, PhD Department of Cardiology, AZ Sint-Jan Hospital Bruges, Belgium
Layout table for additonal information
Responsible Party: Prof. Dr. Mattias Duytschaever, Professor Doctor, AZ Sint-Jan AV
ClinicalTrials.gov Identifier: NCT02925624    
Other Study ID Numbers: 1949
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Keywords provided by Prof. Dr. Mattias Duytschaever, AZ Sint-Jan AV:
ablation index
pulmonary vein isolation
implantable loop recorder
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes