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

January 2, 2018 updated by: prof. dr. Paul Dendale
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

462

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of recurrences of atrial fibrillation or need for new ablation
Time Frame: from 3 months after discharge until 1 year
idem
from 3 months after discharge until 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
The proportion of patients who needed to continue treatment with antiarrhythmics
Time Frame: month 3 until one year
month 3 until one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

prof. dr. Paul Dendale

Investigators

  • Principal Investigator: Paul Dendale, prof. dr., Jessa Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2007

Primary Completion (Actual)

July 31, 2016

Study Completion (Actual)

July 31, 2016

Study Registration Dates

First Submitted

December 20, 2017

First Submitted That Met QC Criteria

January 2, 2018

First Posted (Actual)

January 3, 2018

Study Record Updates

Last Update Posted (Actual)

January 3, 2018

Last Update Submitted That Met QC Criteria

January 2, 2018

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16.46/cardio16.08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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