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

NCT07205679 | Not Yet Recruiting

• 1 other identifier: 125097
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Keywords

Cardiopulmonary Exercise Testing

Outcome Measures

Primary Outcomes (3)

• Exercise duration

  1 month

• Peak oxygen update

  Peak oxygen uptake achieved during a symptom-limited incremental exercise test to task failure.

  1 month

• B-type Natriuretic Peptide (BNP) Test

  1 month

Secondary Outcomes (6)

• Change in maximal HR during exercise

  1 month

• EuroQol (EQ-5D-5L)

  1 month

• Rate of Perceived exertion change during exercise

  1 month

• V̇O2peak change

  1 month

• Change in lactate threshold

  1 month

Study Arms (2)

Cardioversion

Patients with persistent AF and HF scheduled for cardioversion.

Pace and Ablate

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

Eligibility Criteria

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

Study Population

Patients who have been clinically scheduled for either a P\&A or a cardioversion procedure.

You may qualify if:

• Age ≥ 18
• Persistent or Permanent Atrial Fibrillation
• HF - NYHA class II-IVA despite guideline-direct medical therapy
• Rate controlled
• Able to perform stress test
• Scheduled for clinical P\&A OR cardioversion

You may not qualify if:

• Creatinine \>180 μmol/L or eGFR \<30 mL/min/1.73 m2
• Significant valvular heart disease: Moderate to severe tricuspid regurgitation, mitral regurgitation, mitral stenosis, aortic regurgitation, aortic stenosis
• Patients who have had a TAVI, valvular surgery, or CABG within 3 months of enrolment
• Right ventricular systolic pressure \>50mmHg
• Existing pacemaker
• In sinus rhythm
• Predictable vasovagal syncope to pain and sight of blood

Sponsors & Collaborators

• Habib Khan: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Abbie Pardo, MSc

CONTACT

5196612111; abbie.pardo@lhsc.on.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MBBS, PhD

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: October 3, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09