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Atrial FibrillationRHYTHMICNCT04664686

Rate or Rhythm Control in CRT: the RHYTHMIC Study

A study testing AF catheter ablation and AV node ablation in people with Atrial Fibrillation and Heart Failure, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

70 patients with heart failure, AF and CRT with BiV<95% will be randomised to either AF ablation or AV node ablation. Evaluation at 6 months with echocardiography and clinical assessment. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Atrial Fibrillation, Heart Failure
What is being tested?
AF catheter ablation and AV node ablation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteUnited Kingdom
Study dates
19 Oct 2021to 30 Sep 2027
Phase
Interventional
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Christopher A Rinaldi contact

02071889257

aldo.rinaldi@kcl.ac.uk

United Kingdom1 site, 1 recruiting
  • Guys and St Thomas' NHS Foundation Trust

    London, SE1 7EH

    Christopher A Rinaldi, 02071889257, aldo.rinaldi@kcl.ac.uk

    Felicity de Vere, 02071889257, felicity.de_vere@kcl.ac.uk

    Recruiting

Other trials in United Kingdom

About this study

70 patients with heart failure, AF and CRT with BiV<95% will be randomised to either AF ablation or AV node ablation. Evaluation at 6 months with echocardiography and clinical assessment.

Read the detailed description

70 patients with heart failure, AF and CRT with BiV<95% will be recruited from outpatient clinic, pacing clinic or inpatient wards. Patients will be consented and will undergo baseline investigation with a transthoracic 2D echocardiogram, ECG, blood tests, cardiac CT with perfusion imaging, 6 minute walk test (6MWT), cardio-pulmonary exercise test (CPET) and Minnesota Living with Heart Failure Questionnaire. Patients who are successfully screened will be randomized 1:1 to receive AF catheter ablation rhythm control or AV-node ablation rate control.

Ablation Procedure:

Patients will receive either AF catheter ablation or AV-node ablation during the procedure. Patients randomised to AF catheter ablation will receive isolation of all four pulmonary veins and additional lesions, considered indicated by the operator. The procedure will be classified as successful if all four veins are isolated and the patient is in sinus rhythm. Patients may undergo DC-cardioversion under sedation if they remain in atrial fibrillation. AV-node ablation will be performed in line with current standard of care. Patients will also undergo additional research investigations at the time of ablation as follows:

Acute Haemodynamic Study:

All patients will also undergo an acute haemodynamic study with pressure wire assessment of both the right ventricle and the left ventricle at the start and end of the procedure. This involves inserting pressure wires into the RV via a vein in the groin and into the LV via an artery in the wrist or the groin. This will provide novel information on how AF catheter ablation and AV-node ablation affect cardiac contractility.

Invasive Electroanatomical Mapping (Optional):

This is an optional additional procedure that patients may opt into at the time of recruitment. This is performed during the ablation procedure with mapping catheters and software which are CE marked and already in clinical use. Mapping of all four cardiac chambers will be performed. This will be achieved via a vein and an artery in the groin. This will provide novel information on how AF catheter ablation and AV-node ablation affect electrical activation of the atria and ventricles.

Follow-up:

Patients will undergo a 2D transthoracic echocardiogram and ECG 1 week post ablation. Patients will then be followed up at 6 months with 2D transthoracic echocardiogram, ECG, clinical review, CPET, 6MWT, Minnesota Living with Heart Failure Questionnaire and pacing check.

Patients in the AF catheter ablation group who have a recurrence of AF after a 3 month blanking period will be permitted a re-do procedure. The follow-up investigations will take place 6 months after the re-do procedure. If a patient has recurrence of AF after a second ablation procedure and it is felt a third procedure is indicated, this will be performed after the six month follow-up period has ended and the patient is no longer in the study. They will be included in the intention-to-treat analysis.

Being tested
AF catheter ablation, AV node ablation
Medical subject headings
Atrial Fibrillation, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AF catheter ablationProcedure or surgery

    Isolation of all four pulmonary veins and additional lesions, considered indicated by the operator

  • AV node ablationProcedure or surgery

    AV node ablation

Study groups in NCT04664686
Study groupRoleWhat they receive
AF catheter ablationActive comparatorNot described
Receives: Procedure: AF catheter ablation
AV node ablationActive comparatorNot described
Receives: Procedure: AV node ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in ejection fraction

    On 2D echocardiography

    Measured: 6 months

Secondary outcomes (8)
  1. Difference in left ventricular end systolic volume

    On 2D echocardiography

    Measured: 6 months

  2. Difference in biventricular pacing percentage

    On pacemaker check

    Measured: 6 months

  3. Difference in quality of life

    Assessed by Packer's Clinical Composite Score

    Measured: 6 months

  4. Difference in NYHA class

    On clinical assessment

    Measured: 6 months

  5. Difference in heart failure symptoms

    Assessed by Minnesota Living with Heart Failure Questionnaire

    Measured: 6 months

  6. Difference in 6-minute walk test

    Measured: 6 months

  7. Difference in VO2 max

    Assessed via cardio pulmonary exercise test (CPET)

    Measured: 6 months

  8. Difference in AF burden

    Assessed via pacing check

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2020
  2. Study start19 Oct 2021
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04664686
Sponsor's protocol ID
265388
Acronym
RHYTHMIC
Status last verified
Jan 2026
First submitted
10 Dec 2020
Last updated
26 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing AF catheter ablation and AV node ablation in people with Atrial Fibrillation and Heart Failure, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.

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 5 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: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Christopher A Rinaldi (02071889257, aldo.rinaldi@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in ejection fraction (time frame: 6 months). 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 26 Jan 2026.

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Rate or Rhythm Control in CRT: the RHYTHMIC Study | AzTrials