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Does Cardiac Rehabilitation Reduce the Risk of Recurrence of Atrial Fibrillation Following the First Catheter Ablation?

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
rehabilitation
Sponsored by
prof. dr. Paul Dendale
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • an ablation for AF (Atrial fibrillation)

Exclusion Criteria:

  • a complicated ablation
  • a prosthetic heart valve
  • a severe valvulopathy,
  • hyperthyroidism at the time of the ablation,
  • pregnancy and breastfeeding,
  • intensive sport (more than 1 hour a day),
  • a myocardial infarction or a thromboembolic event within 3 months after the ablation,
  • a pacemaker
  • end-stage renal disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Rehabilitation group

    No rehabilitation

    Arm Description

    this group follows a 3 months rehab program

    This group does not follow a rehab program

    Outcomes

    Primary Outcome Measures

    Number of recurrences of atrial fibrillation or need for new ablation
    idem

    Secondary Outcome Measures

    The proportion of patients who needed to continue treatment with antiarrhythmics

    Full Information

    First Posted
    December 20, 2017
    Last Updated
    January 2, 2018
    Sponsor
    prof. dr. Paul Dendale
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03389633
    Brief Title
    Does Cardiac Rehabilitation Reduce the Risk of Recurrence of Atrial Fibrillation Following the First Catheter Ablation?
    Official Title
    Does Cardiac Rehabilitation Reduce the Risk of Recurrence of Atrial Fibrillation Following the First Catheter Ablation?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2007 (Actual)
    Primary Completion Date
    July 31, 2016 (Actual)
    Study Completion Date
    July 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    prof. dr. Paul Dendale

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Many risk factors contribute to the onset of atrial fibrillation. This study is specifically concerned with the effect of addressing these risk factors by cardiac rehabilitation on the risk of recurrence of atrial fibrillation following catheter ablation. A non-randomized, retrospective study was performed on patients treated with a catheter ablation for atrial fibrillation. The intervention group consisted of patients who chose to participate in the cardiac rehabilitation program. The control group only received standard care. The primary objective was to examine whether cardiac rehabilitation following the first ablation for atrial fibrillation resulted in a reduction of the time to or the risk of recurrence of atrial fibrillation or the need for a second ablation within 1 year after the first ablation. A Kaplan-Meier analysis was used to examine the primary objective. The secondary objectives of this study were to examine whether cardiac rehabilitation following the first ablation for atrial fibrillation had an effect on the evolution of the patients' BMI (a Mann-Whitney U test), the number of recurrences of atrial fibrillation (a Poisson regression) and the proportion of patients who need to continue treatment with antiarrhythmics 3 months following the first ablation (a chi-square test).
    Detailed Description
    The intervention group follows a 3 months rehab program consisting of training, education, coaching and medical follow-up. The control group are patients that chose not to follow this program. This is a retrospective non randomized trial

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    462 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Rehabilitation group
    Arm Type
    Experimental
    Arm Description
    this group follows a 3 months rehab program
    Arm Title
    No rehabilitation
    Arm Type
    No Intervention
    Arm Description
    This group does not follow a rehab program
    Intervention Type
    Other
    Intervention Name(s)
    rehabilitation
    Primary Outcome Measure Information:
    Title
    Number of recurrences of atrial fibrillation or need for new ablation
    Description
    idem
    Time Frame
    from 3 months after discharge until 1 year
    Secondary Outcome Measure Information:
    Title
    The proportion of patients who needed to continue treatment with antiarrhythmics
    Time Frame
    month 3 until one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: an ablation for AF (Atrial fibrillation) Exclusion Criteria: a complicated ablation a prosthetic heart valve a severe valvulopathy, hyperthyroidism at the time of the ablation, pregnancy and breastfeeding, intensive sport (more than 1 hour a day), a myocardial infarction or a thromboembolic event within 3 months after the ablation, a pacemaker end-stage renal disease.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paul Dendale, prof. dr.
    Organizational Affiliation
    Jessa Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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