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Surgical or Catheter Ablation of Lone Atrial Fibrillation (AF) Patients (SCALAF)

This study has been terminated.
(Enrollments slowed down significantly, despite several attempts to re-launch.)
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center )
ClinicalTrials.gov Identifier:
NCT00703157
First received: June 19, 2008
Last updated: May 15, 2017
Last verified: May 2017
Results First Received: March 22, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Atrial Fibrillation
Interventions: Procedure: Catheter Ablation
Procedure: Surgical Ablation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eighty (80) subjects were enrolled, of whom 52 were randomized. A Reveal XT Implantable device was implanted in all subjects after Informed Consent. The subjects were followed for a minimum of 1 week and a maximum of 6 months. If the subject demonstrated a minimum of 10% AF burden during this period and had complaints, the subject was randomized.

Reporting Groups
  Description
Catheter Catheter Ablation
Surgery Surgical Ablation

Participant Flow:   Overall Study
    Catheter   Surgery
STARTED   26   26 
6 Months FU   25   25 
24 Months FU   22   24 
COMPLETED   22   24 
NOT COMPLETED   4   2 
Lost to Follow-up                0                1 
source data permanently lost/ other                4                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Catheter Catheter Ablation
Surgery Surgical Ablation
Total Total of all reporting groups

Baseline Measures
   Catheter   Surgery   Total 
Overall Participants Analyzed 
[Units: Participants]
 26   26   52 
Age 
[Units: Years]
Mean (Standard Deviation)
 61  (7)   55  (9)   58  (9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female   6   5   11 
Male   20   21   41 
NYHA Class [1] 
[Units: Participants]
Count of Participants
     
 25   23   48 
II   1   3   4 
[1]

The New York Heart Association (NYHA) Functional Classification places patients in one of four categories based on their limitations during physical activity.The limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina.

Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).

Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).



  Outcome Measures
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1.  Primary:   Change in AF Burden After Ablation Therapy Measured With REVEAL-XT Implantable Device.   [ Time Frame: Baseline through 3-6 months post-ablation ]

2.  Secondary:   Treatment Failures Requiring Redo or Alternative Therapy   [ Time Frame: Time from procedure until 6 months post-ablation ]

3.  Secondary:   Number of Subjects With Adverse Events, Associated With the Ablation Procedure   [ Time Frame: Time from procedure ]

4.  Secondary:   Mortality and Hospitalization   [ Time Frame: Time from procedure until 24 months post-ablation ]

5.  Secondary:   Duration, Burden and Costs of Treatment Procedures   [ Time Frame: Through 24 months post- ablation ]

6.  Secondary:   Reduced Number, Duration and Severity of AF Symptoms   [ Time Frame: Through 24 months post-ablation ]

7.  Secondary:   Symptoms Associated With Atrial Arrhythmias   [ Time Frame: Through 24 months post-ablation ]

8.  Secondary:   Occurences of Treatment of Arrhythmic Episodes   [ Time Frame: Through 24 months post-ablation ]

9.  Secondary:   Assessment of AF Burden   [ Time Frame: Through 24 months post-ablation ]

10.  Secondary:   Reduced Anti-arrhythmic Drug Requirement   [ Time Frame: Through 24 months post-ablation ]

11.  Secondary:   Left Atrial Dimension and Contractility   [ Time Frame: Through 24 months post-ablation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study stopped early, prior to meeting the target number of subjects per group. The reported results and conclusions are based on these limited data.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ber Kleijnen
Organization: Medtronic Bakken Research Center, Coronary and Structural Heart Disease Management
phone: +31 (0) 43 356 6566
e-mail: ber.kleijnen@medtronic.com



Responsible Party: Medtronic Cardiovascular ( Medtronic Bakken Research Center )
ClinicalTrials.gov Identifier: NCT00703157     History of Changes
Other Study ID Numbers: BRC-CS
Study First Received: June 19, 2008
Results First Received: March 22, 2017
Last Updated: May 15, 2017