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NCT07205679Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 3 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
40 (estimated)
First submitted
28 Jul 2025
Start date
1 Oct 2025
Primary completion date
31 Jul 2026
Lead sponsor
Habib Khan
NCT number
NCT07205679

What you commit to

  • Study type: Observational
  • Planned participants: 40
  • From 1 Oct 2025 to the primary completion date, 31 Jul 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

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

Lab values

  • Creatinine \>180 μmol/L or eGFR \<30 mL/min/1.73 m2

Other

  • Right ventricular systolic pressure \>50mmHg
  • Existing pacemaker
  • In sinus rhythm
  • Predictable vasovagal syncope to pain and sight of blood

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.