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

NCT03389633 | Completed

• 1 other identifier: 16.46/cardio16.08
• Study Type: interventional
• Target: 462
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

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

  idem

  from 3 months after discharge until 1 year

Secondary Outcomes (1)

• The proportion of patients who needed to continue treatment with antiarrhythmics

  month 3 until one year

Study Arms (2)

Rehabilitation group

EXPERIMENTAL

this group follows a 3 months rehab program

Other: rehabilitation

No rehabilitation

NO INTERVENTION

This group does not follow a rehab program

Interventions

rehabilitation OTHER

Rehabilitation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• an ablation for AF (Atrial fibrillation)

You may not qualify if:

• 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.

Sponsors & Collaborators

• prof. dr. Paul Dendale: lead

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Paul Dendale, prof. dr.

  Jessa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of cardiovascular pathophysiology

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: January 3, 2018
• Study Start: January 1, 2007
• Primary Completion: July 31, 2016
• Study Completion: July 31, 2016
• Last Updated: January 3, 2018

Record last verified: 2017-12