Impact of Cardiac Prehabilitation, REhabilitation and Patient EDucation on Outcomes in Patients Undergoing First-time AF Ablation

NCT06042231 | Active Not Recruiting

• 1 other identifier: FO596122
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial fibrillation (AF) is a term used to describe an irregular, and often very rapid, heartbeat. AF increases the risk of a number of diseases associated with the heart and cardiovascular system. Ablation is a procedure to treat AF. It uses small burns or freezes to cause some scarring on the inside of the heart to help break up the electrical signals that cause irregular heartbeats. This can help the heart maintain a normal rhythm. Currently patients who are referred for AF ablation do not receive any additional support as part of standard care to improve the outcomes of their ablation procedure. Whereas cardiac rehabilitation is a recognised part of comprehensive care for coronary heart disease patients (patients whose hearts struggle to receive blood), with exercise and education consistently identified as central elements to their rehabilitation. This treatment is not yet recommended for AF ablation patients. Therefore, the CREED AF Study is investigating whether a tailored comprehensive exercise and education intervention can improve outcomes in patients who are undergoing first time AF ablation. Central to the CREED AF study is the 'prehabilitation' intervention, whereby exercise and education training will be conducted before AND after AF ablation. 106 participants is the target recruitment, they will be randomised to either receive the CREED AF intervention (exercise and education intervention before AND after AF ablation) or a standard care (control) group. The standard care group will receive a one off 1-to-1 patient education session with a trained practitioner before their AF ablation procedure. This research study does not affect the AF ablation procedure that patients will have as part of their standard of care.

Conditions

Atrial Fibrillation

Keywords

AF ablation; Pulmonary vein isolation; VO2peak

Outcome Measures

Primary Outcomes (1)

• VO2 peak measurements

  VO2peak measured from cardiopulmonary exercise testing (CPET) at baseline and 10 weeks (±2 weeks) post AF ablation between the standard care and intervention arms.

  12 months

Secondary Outcomes (6)

• Quality of life questionnaire

  12 months

• Quality of life questionnaire

  12 months

• Quality of life questionnaire

  12 months

• Cost effectiveness of CREED AF intervention

  12 months

• AF recurrence in short- and long-term

  12 months

Study Arms (2)

Exercise Intervention

EXPERIMENTAL

Behavioral: Exercise Intervention; Behavioral: Education Intervention

Standard Care

NO INTERVENTION

Interventions

Exercise Intervention BEHAVIORAL

Exercise and education intervention. Participants will be prescribed a tailored exercise program to complete before ('pre-habilitation') and after their AF ablation procedure (rehabilitation).

Exercise Intervention

Education Intervention BEHAVIORAL

Education intervention. Participants will be given a 1-1 education session (up to 3 sessions) before and after their AF ablation procedure. Participants will be given behavioural strategies to improve adherence and compliancec to risk-factor modification.

Exercise Intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients listed for a first-time AF ablation procedure
• Patients aged ≥18 years

You may not qualify if:

• Pregnancy
• Lack of capacity to consent and participate
• Presence of contraindications or limiting physical or mental health co-morbidity preventing travel, safe exercise, or productive engagement with the trial
• Unable to access online exercise and support sessions from home
• Participating in a research trial that will impact on their standard AF ablation procedure
• Unable to understand basic spoken and written English

Sponsors & Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust: lead

Study Sites (1)

University Hospital Coventry and Warwickshire NHS Trust

Coventry, West Midlands, CV22DX, United Kingdom

Location

Related Publications (1)

• Chandan N, Matthews V, He H, Lachlan T, Lim VG, Joshi S, Hee SW, Noufaily A, Parkes E, Patel S, Andronis L, Shakespeare J, Eftekhari H, Ali A, McGregor G, Osman F. Cardiac prehabilitation, rehabilitation and education in first-time atrial fibrillation (AF) ablation (CREED AF): Study protocol for a randomised controlled trial. PLoS One. 2024 Oct 3;19(10):e0310951. doi: 10.1371/journal.pone.0310951. eCollection 2024.

  PMID: 39361572 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Faizel Osman

  University Hospitals Coventry & Warwickshre NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: September 18, 2023
• Study Start: November 2, 2023
• Primary Completion: June 30, 2025
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-02

Locations

GB (1)