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

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ClinicalTrials.gov Identifier: NCT03389633
Recruitment Status : Completed
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
prof. dr. Paul Dendale, Hasselt University

Study Description
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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).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Other: rehabilitation Not Applicable

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 462 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Cardiac Rehabilitation Reduce the Risk of Recurrence of Atrial Fibrillation Following the First Catheter Ablation?
Actual Study Start Date : January 1, 2007
Actual Primary Completion Date : July 31, 2016
Actual Study Completion Date : July 31, 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Rehabilitation group
this group follows a 3 months rehab program
 Other: rehabilitation
No Intervention: No rehabilitation
This group does not follow a rehab program


Outcome Measures
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Primary Outcome Measures :
  1. Number of recurrences of atrial fibrillation or need for new ablation [ Time Frame: from 3 months after discharge until 1 year ]
    idem


Secondary Outcome Measures :
  1. The proportion of patients who needed to continue treatment with antiarrhythmics [ Time Frame: month 3 until one year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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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): NCT03389633


Sponsors and Collaborators
prof. dr. Paul Dendale
Investigators
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Principal Investigator: Paul Dendale, prof. dr. Jessa Hospital
More Information
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Responsible Party: prof. dr. Paul Dendale, Professor of cardiovascular pathophysiology, Hasselt University
ClinicalTrials.gov Identifier: NCT03389633    
Other Study ID Numbers: 16.46/cardio16.08
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Pathologic Processes
Disease Attributes