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.
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.
United Kingdom1 site, 1 recruiting
- 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
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.
- Conditions
- Atrial Fibrillation, Heart Failure
- 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 group | Role | What they receive |
|---|---|---|
| AF catheter ablation | Active comparator | Not described Receives: Procedure: AF catheter ablation |
| AV node ablation | Active comparator | Not described Receives: Procedure: AV node ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in ejection fraction
On 2D echocardiography
Measured: 6 months
Secondary outcomes (8)
Difference in left ventricular end systolic volume
On 2D echocardiography
Measured: 6 months
Difference in biventricular pacing percentage
On pacemaker check
Measured: 6 months
Difference in quality of life
Assessed by Packer's Clinical Composite Score
Measured: 6 months
Difference in NYHA class
On clinical assessment
Measured: 6 months
Difference in heart failure symptoms
Assessed by Minnesota Living with Heart Failure Questionnaire
Measured: 6 months
Difference in 6-minute walk test
Measured: 6 months
Difference in VO2 max
Assessed via cardio pulmonary exercise test (CPET)
Measured: 6 months
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.
- First posted11 Dec 2020
- Study start19 Oct 2021
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- 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)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Christopher A Rinaldi, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rate or Rhythm Control in CRT: the RHYTHMIC Study
- ClinicalTrials.gov ID
- NCT04664686
- Acronym / sponsor ID
- RHYTHMIC / 265388
- Conditions
- Atrial Fibrillation, Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 11 Dec 2020 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AF catheter ablation | Active comparator | Procedure: AF catheter ablation |
| AV node ablation | Active comparator | Procedure: AV node ablation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Life expectancy <1 year
- Presence of atrial or ventricular thrombus
- Permanent atrial fibrillation
- Mechanical aortic valve replacement
- Severe peripheral vascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AF catheter ablationIsolation of all four pulmonary veins and additional lesions, considered indicated by the operator | Procedure or surgery | AF catheter ablation |
| AV node ablationAV node ablation | Procedure or surgery | AV node ablation |
Primary outcome
Difference in ejection fraction
Time frame: 6 months
On 2D echocardiography
8 secondary outcomes
Difference in left ventricular end systolic volume
Time frame: 6 months
Difference in biventricular pacing percentage
Time frame: 6 months
Difference in quality of life
Time frame: 6 months
Difference in NYHA class
Time frame: 6 months
Difference in heart failure symptoms
Time frame: 6 months
Difference in 6-minute walk test
Time frame: 6 months
Difference in VO2 max
Time frame: 6 months
Difference in AF burden
Time frame: 6 months
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 26 Jan 2026.
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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.
Christopher A Rinaldi principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
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.