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Left Atrial Ablation of Paroxysmal Atrial Fibrillation With Implantable Loop Recorder Follow Up Study: The LAAPITUP 2 Study (LAAPITUP 2)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2014 by Neil Sulke, Eastbourne General Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01504451
First Posted: January 5, 2012
Last Update Posted: June 26, 2014
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.
Information provided by (Responsible Party):
Neil Sulke, Eastbourne General Hospital
December 30, 2011
January 5, 2012
June 26, 2014
April 2012
April 2015   (Final data collection date for primary outcome measure)
AF burden [ Time Frame: 12 months after ablation ]
Total proportion of time spent in AF as assessed by ILR
Same as current
Complete list of historical versions of study NCT01504451 on ClinicalTrials.gov Archive Site
  • Time to AF recurrence [ Time Frame: Up to one year ]
    Time to recurrence of any AF after ablation
  • Time to first symptomatic AF recurrence [ Time Frame: Up to one year ]
    Time to first symptomatic AF recurrence as assessed by ILR.
  • Change in QoL measures [ Time Frame: 12 months after ablation ]
    Change in Quality of Life measures assessed by questionnaire.
Same as current
Not Provided
Not Provided
 
Left Atrial Ablation of Paroxysmal Atrial Fibrillation With Implantable Loop Recorder Follow Up Study: The LAAPITUP 2 Study
Left Atrial Ablation of Paroxysmal Atrial Fibrillation With Implantable Loop Recorder Follow Up Study 2
This study is designed to compare three different techniques in ablation of paroxysmal atrial fibrillation. Namely, the Medtronic multi-electrode phased radiofrequency ablation system, the Biosense Webster irrigated multi-electrode phased radiofrequency ablation system, and minimally invasive thoracoscopic surgical ablation. The study hypothesis is that surgical and Biosense Webster ablation are non-inferior to Medtronic ablation.
A target of 75 participants will be randomised 1:1:1 to one of the three treatment arms. Each participant will have an implantable loop recorder (ILR) prior to ablation in order to assess AF burden. After ablation, each participant will be followed up for a year. The ILR will be used to assess reduction in AF burden.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Paroxysmal Atrial Fibrillation
  • Device: ILR insertion
    Insertion of implantable loop recorder
  • Procedure: AF ablation
    AF ablation
  • Active Comparator: Biosense Webster ablation
    Biosense Webster irrigated multi-electrode phased radiofrequency AF ablation
    Interventions:
    • Device: ILR insertion
    • Procedure: AF ablation
  • Active Comparator: Surgical ablation
    Minimally invasive thoracoscopic surgical AF ablation
    Interventions:
    • Device: ILR insertion
    • Procedure: AF ablation
  • Active Comparator: Medtronic ablation
    Medtronic multi-electrode phased radiofrequency AF ablation
    Interventions:
    • Device: ILR insertion
    • Procedure: AF ablation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
75
May 2015
April 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Symptomatic paroxysmal AF suitable for AF ablation
  • Age > 18 years old
  • Informed consent to participate in this study.

Exclusion Criteria:

  • Pre-existing ILRs or permanent pacemakers that do not allow for continuous monitoring for AF occurrence, or are not MRI-safe.
  • Unable to undergo general anaesthesia for AF ablation.
  • Previous cardiac surgery, such as coronary artery bypass grafting or valvular surgery.
  • Scheduled for elective cardiac surgery, such as coronary artery bypass grafting or valvular surgery.
  • Previous thoracic surgery.
  • Participation in a conflicting study.
  • Potential participants who are mentally incapacitated and cannot consent or comply with follow-up
  • Pregnancy
  • Other cardiac rhythm disorders
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01504451
LAAPITUP 2
Yes
Not Provided
Not Provided
Neil Sulke, Eastbourne General Hospital
Neil Sulke
Not Provided
Principal Investigator: Neil Sulke, MD Eastbourne General Hospital
Principal Investigator: Stephen S Furniss, MD Eastbourne General Hospital
Eastbourne General Hospital
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP