Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04664686
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2020-12-10
Brief Title:
Rate or Rhythm Control in CRT the RHYTHMIC Study
Sponsor:
Guys and St Thomas NHS Foundation Trust
Organization:
Guys and St Thomas NHS Foundation Trust
Study Overview
Official Title:
Rate or Rhythm Control in CRT the RHYTHMIC Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
Not yet recruiting
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RHYTHMIC
Brief Summary:
70 patients with heart failure AF and CRT with BiV95 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 BiV95 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 11 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None