Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00111527
Status:
COMPLETED
Last Update Posted:
2010-03-23
First Post:
2005-05-20
Brief Title:
APAF Assessment of Cardiac Resynchronization Therapy in Patients With Permanent Atrial Fibrillation
Sponsor:
Arcispedale Santa Maria Nuova-IRCCS
Organization:
Arcispedale Santa Maria Nuova-IRCCS
Study Overview
Official Title:
An Assessment of the Echo-guided Optimal Cardiac Resynchronization Therapy in Patients Undergoing Ablate And Pace Therapy for Permanent Atrial Fibrillation
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
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:
None
Brief Summary:
A suboptimal level of resynchronization cardiac resynchronization therapy CRT achieved in many patients with actual standards and techniques based on tissue-Doppler echocardiography could be more effective to obtain better CRT results Eligible patients who successfully received atrioventricular AV junction ablation and biventricular BiV pacing are randomised to a comparison between a strategy of right ventricular RV apical pacing with delayed CRT based on clinical indications with a strategy of early optimal CRT based on an echocardiographic stratification
End-points
Acute echo comparison acute echo study
Quality of life and exercise tolerance Short-term clinical study
Composite end-point of CRT clinical failure Long-term clinical study
End-points
Acute echo comparison acute echo study
Quality of life and exercise tolerance Short-term clinical study
Composite end-point of CRT clinical failure Long-term clinical study
Detailed Description:
Background Cardiac resynchronization therapy CRT in patients in atrial fibrillation AF seems to provide modest favorable effect compared with RV pacing In the Optimal Pacing SITE OPSITE trial the results were heterogeneous The situation was almost certainly one in which some patients are showing marked clinical benefit with LV-based pacing balanced by other patients in whom RV was the best choice Therefore with the actual standards CRT pacing cannot be recommended as a first line treatment for all patients with AF and refractory heart failure and new criteria to identify the patients who might benefit are needed Furthermore a pre-requisite for CRT in patients with AF is the presence of stable 3rd degree AV block which usually implies the need for performing catheter ablation of the AV junction
Study hypothesis We hypothesized that a suboptimal level of resynchronization is achieved in many patients with actual standards and that some techniques based on tissue-Doppler echocardiography could be more effective to obtain better hopefully optimal CRT results
Objective The aim of the APAF heart failure HF trial is to compare in patients affected by permanent AF and refractory heart failure a strategy of delayed CRT based on clinical indications with a strategy of early optimal CRT based on an echocardiographic stratification
Study protocol Eligible patients who successfully received AV junction ablation and biventricular pacing are randomised to a comparison between a strategy of RV apical pacing with delayed CRT based on clinical indications with a strategy of early optimal CRT based on an echocardiographic stratification The optimal CRT is defined as the shortest intra-LV delay obtained with tissue-doppler echocardiography among RV LV and BiV optimised VV interval
An acute echocardiographic evaluation is performed shortly after randomisation A short-term clinical evaluation is performed after 6 months A long-term clinical evaluation is performed up to 24 months
End-points
Acute echo comparison acute echo study
Quality of life and exercise tolerance Short-term clinical study
Composite end-point of CRT clinical failure Long-term clinical study
Study size The study will randomise 458 patients and will be conducted in 46 centres with an average of 10 patients per centre Patient enrolment time is anticipated to last 2 years As the study will continue for a period of 12 months after the enrolment of the last patient total study duration will be approximately 3 years
Study hypothesis We hypothesized that a suboptimal level of resynchronization is achieved in many patients with actual standards and that some techniques based on tissue-Doppler echocardiography could be more effective to obtain better hopefully optimal CRT results
Objective The aim of the APAF heart failure HF trial is to compare in patients affected by permanent AF and refractory heart failure a strategy of delayed CRT based on clinical indications with a strategy of early optimal CRT based on an echocardiographic stratification
Study protocol Eligible patients who successfully received AV junction ablation and biventricular pacing are randomised to a comparison between a strategy of RV apical pacing with delayed CRT based on clinical indications with a strategy of early optimal CRT based on an echocardiographic stratification The optimal CRT is defined as the shortest intra-LV delay obtained with tissue-doppler echocardiography among RV LV and BiV optimised VV interval
An acute echocardiographic evaluation is performed shortly after randomisation A short-term clinical evaluation is performed after 6 months A long-term clinical evaluation is performed up to 24 months
End-points
Acute echo comparison acute echo study
Quality of life and exercise tolerance Short-term clinical study
Composite end-point of CRT clinical failure Long-term clinical study
Study size The study will randomise 458 patients and will be conducted in 46 centres with an average of 10 patients per centre Patient enrolment time is anticipated to last 2 years As the study will continue for a period of 12 months after the enrolment of the last patient total study duration will be approximately 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None