Cardiovascular Performance and Exercise Response in Patients With Persistent or Permanent Atrial Fibrillation and Heart Failure Pre and Post Cardioversion or Pace and Ablate

NCT ID: NCT07205679

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-07-31

Brief Summary

Heart Failure (HF) and Atrial Fibrillation (AF) are two conditions that commonly occur together. Clinical guidelines consider a resting heart rate of 100-110 beats per minute (bpm) acceptable for patients with HF and AF while 72 bpm is considered the average in healthy populations. A higher resting heart rate indicates that the heart is working harder to meet bodily demands, and though it may be considered safe for patients with HF and AF to have a heart rate of 110 bpm, the investigators believe it is having a significant negative impact on patient quality of life and their ability to exercise. The current study will test exercise ability using a treadmill test before and after either a cardioversion, where the patient's heartbeat is reset using electric shocks, or a pace and ablate method, where the patient receives a pacemaker to regulate their heart rhythm and an ablation (intentional damaging) of the node that coordinates the beats within the heart. This will allow investigators to compare how the heart responds to exercise when the patient is on rate-control and anticoagulation medication therapy (before cardioversion or pace and ablate) and after the procedures. During exercise, the investigators will do a blood test that lets investigators know how efficiently the heart is working and record any symptoms experienced. The investigators will also collect information about the patient's quality of life. Using this information, the investigators hope to better understand whether the current standard of a resting heart rate of 100-110 bpm is ideal for patient quality of life.

Conditions

Atrial Fibrillation (AF); Heart Failure - NYHA II - IV; Pacemaker; Cardioversion; Ablation Therapy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cardioversion

Patients with persistent AF and HF scheduled for cardioversion.

No interventions assigned to this group

Pace and Ablate

Patients with chronic AF and HF who are scheduled for P\&A procedure.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18

2. Persistent or Permanent Atrial Fibrillation

3. HF - NYHA class II-IVA despite guideline-direct medical therapy

4. Rate controlled

5. Able to perform stress test

6. Scheduled for clinical P&A OR cardioversion

Exclusion Criteria

1. Creatinine >180 μmol/L or eGFR <30 mL/min/1.73 m2

2. Significant valvular heart disease: Moderate to severe tricuspid regurgitation, mitral regurgitation, mitral stenosis, aortic regurgitation, aortic stenosis

3. Patients who have had a TAVI, valvular surgery, or CABG within 3 months of enrolment

4. Right ventricular systolic pressure >50mmHg

5. Existing pacemaker

6. In sinus rhythm

7. Predictable vasovagal syncope to pain and sight of blood

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Habib Khan

OTHER

Sponsor Role: lead

Responsible Party

Habib Khan

MBBS, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Abbie Pardo, MSc

Role: CONTACT

abbie.pardo@lhsc.on.ca

5196612111 ext. 86459

Other Identifiers

125097

Identifier Type: OTHER

Identifier Source: secondary_id

125097

Identifier Type: -

Identifier Source: org_study_id