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Sponsors and Collaborators: |
Arcispedale Santa Maria Nuova Medtronic |
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Information provided by: | Arcispedale Santa Maria Nuova |
ClinicalTrials.gov Identifier: | NCT00111527 |
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:
Condition | Intervention | Phase |
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Congestive Heart Failure Atrial Fibrillation |
Other: Optimized echo-guided CRT pacing Other: normal RV pacing |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | An Assessment of the Echo-Guided Optimal Cardiac Resynchronization Therapy in Patients Undergoing 'Ablate And Pace' Therapy for Permanent Atrial Fibrillation |
Estimated Enrollment: | 458 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Normal RV pacing
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Other: normal RV pacing
PM or ICD implant according to patient indication
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2: Experimental
Echo-guided optimization of pacing
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Other: Optimized echo-guided CRT pacing
Echo-TDI guided VV-delay optimization
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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:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Italy | |
Arcispedale S Maria Nuova | Recruiting |
Reggio Emilia, Italy, 42100 | |
Contact: Carlo Menozzi, MD +30 0522 296111 ext 574 menozzi.carlo@asmn.re.it | |
Contact: Nicola Bottoni, MD +30 0522 296111 ext 574 bottoni.nicola@asmn.re.it | |
Principal Investigator: Carlo Menozzi, MD | |
Italy, Genova | |
Michele Brignole | Not yet recruiting |
Lavagna, Genova, Italy, 16033 | |
Contact: Michele Brignole, MD +39 0185 329111 ext 569 mbrignole@ASL4.liguria.it | |
Contact: Daniele Oddone, MD +39 0185 329111 ext 569 aritmo@ASL4.liguria.it | |
Principal Investigator: Michele Brignole, MD |
Principal Investigator: | Michele Brignole, MD | Ospedali del Tigullio, Lavagna, Italy |
Principal Investigator: | Carlo Menozzi, MD | Ospedale S Maria Nuova, Reggio Emilia, Italy |
Responsible Party: | Ospedali del Tigullio ( Michele Brignole ) |
Study ID Numbers: | 1893A |
Study First Received: | May 20, 2005 |
Last Updated: | May 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00111527 |
Health Authority: | Italy: Ministry of Health |
Heart failure Atrial fibrillation Cardiac resynchronization Cardiac pacing |
Catheter ablation Quality of life Echocardiography |
Heart Failure Heart Diseases Quality of Life Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |