Comparing AF ablation and AV node ablation for heart failure patients
Rate or Rhythm Control in CRT: the RHYTHMIC Study
NA · Guy's and St Thomas' NHS Foundation Trust · NCT04664686
This study tests whether a heart procedure to control rhythm or a procedure to control rate works better for heart failure patients with atrial fibrillation who are already getting special heart therapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust (other) |
| Locations | 1 site (London) |
| Trial ID | NCT04664686 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves 70 patients with heart failure and atrial fibrillation who are receiving cardiac resynchronization therapy (CRT) but have less than 95% biventricular pacing. Participants will be randomized to receive either AF catheter ablation for rhythm control or AV-node ablation for rate control. The study will evaluate the outcomes at six months through echocardiography and clinical assessments, including various tests to measure heart function and quality of life. The goal is to determine which approach is more effective in managing their condition.
Who should consider this trial
Good fit: Ideal candidates are patients with heart failure, atrial fibrillation, and CRT who have less than 95% biventricular pacing and meet specific clinical criteria.
Not a fit: Patients with a life expectancy of less than one year, permanent atrial fibrillation, or those with certain contraindications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective treatment for heart failure patients with atrial fibrillation, potentially improving their quality of life and heart function.
How similar studies have performed: Other studies have shown promising results with catheter ablation techniques in similar patient populations, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to provide informed consent to participate and willing to comply with the clinical investigation plan and follow-up schedule. * QRS duration \>120ms on surface ECG, severe left ventricular systolic impairment (EF≤35%) and clinical symptoms of heart failure despite optimum medical therapy (NYHA class II-IV) at time of CRT implant or upgrade * Successful CRT implant or upgrade including atrial lead * Biventricular pacing percentage \<95% secondary to atrial fibrillation at least 3 months post implant or upgrade * Clinically indicated for AV node ablation Exclusion Criteria: * Life expectancy \<1 year * Presence of atrial or ventricular thrombus * Permanent atrial fibrillation * Mechanical aortic valve replacement * Severe peripheral vascular disease * Female participants who are pregnant, lactating or planning pregnancy during the course of the study. * Participation in other studies with active treatment / investigational arm
Where this trial is running
London
- Guys and St Thomas' NHS Foundation Trust — London, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Christopher A Rinaldi — Guy's and St Thomas' NHS Foundation Trust
- Study coordinator: Christopher A Rinaldi
- Email: aldo.rinaldi@kcl.ac.uk
- Phone: 02071889257
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atrial Fibrillation, Heart Failure