Atrial Fibrillation (AF)CPEX-CPANCT07205679
Cardiovascular Performance and Exercise Response in Patients With Persistent or Permanent Atrial Fibrillation and Heart Failure Pre and Post Cardioversion or Pace and Ablate
An observational study of Atrial Fibrillation (AF) and Heart Failure - NYHA II - IV, run by Habib Khan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Heart Failure - NYHA II - IV, Pacemaker
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been clinically scheduled for either a P\&A or a cardioversion procedure.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise duration
Measured: 1 month
Peak oxygen update
Peak oxygen uptake achieved during a symptom-limited incremental exercise test to task failure.
Measured: 1 month
B-type Natriuretic Peptide (BNP) Test
Measured: 1 month
Secondary outcomes (6)
Change in maximal HR during exercise
Measured: 1 month
EuroQol (EQ-5D-5L)
Participants indicate abilities with respect to five dimensions of health. Higher scores indicate greater impairment.
Measured: 1 month
Rate of Perceived exertion change during exercise
Measured: 1 month
V̇O2peak change
Measured: 1 month
Change in lactate threshold
Measured: 1 month
Kansas City Cardiomyopathy Questionnaire
Change in Kansas HF score from baseline. KCCQ is a 23-item self-administered questionnaire that measures the participant's perception of their health status, including their HF symptoms, impact on physical and social function and how their HF impacts the quality of life (QoL). KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), QoL (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Oct 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Habib Khan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Habib Khan, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205679
- Sponsor's protocol ID
- 125097
- Other IDs
- 125097
- Acronym
- CPEX-CPA
- Status last verified
- Sep 2025
- First submitted
- 28 Jul 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Performance and Exercise Response in Patients With Persistent or Permanent Atrial Fibrillation and Heart Failure Pre and Post Cardioversion or Pace and Ablate
- ClinicalTrials.gov ID
- NCT07205679
- Acronym / sponsor ID
- CPEX-CPA / 125097
- Conditions
- Atrial Fibrillation (AF), Heart Failure - NYHA II - IV, Pacemaker, Cardioversion, Ablation Therapy
- Keywords
- Cardiopulmonary Exercise Testing
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Habib KhanUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been clinically scheduled for either a P\&A or a cardioversion procedure.
Key inclusion criteria (6 listed)
- Age ≥ 18
- Persistent or Permanent Atrial Fibrillation
- HF - NYHA class II-IVA despite guideline-direct medical therapy
- Rate controlled
- Able to perform stress test
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Exercise duration
Time frame: 1 month
Peak oxygen update
Time frame: 1 month
Peak oxygen uptake achieved during a symptom-limited incremental exercise test to task failure.
B-type Natriuretic Peptide (BNP) Test
Time frame: 1 month
6 secondary outcomes
Change in maximal HR during exercise
Time frame: 1 month
EuroQol (EQ-5D-5L)
Time frame: 1 month
Rate of Perceived exertion change during exercise
Time frame: 1 month
V̇O2peak change
Time frame: 1 month
Change in lactate threshold
Time frame: 1 month
Kansas City Cardiomyopathy Questionnaire
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF) and Heart Failure - NYHA II - IV, run by Habib Khan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abbie Pardo, MSc (5196612111 ext. 86459, abbie.pardo@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise duration (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.