Heart Failure Clinical Trial
— TRAJECTORIESOfficial title:
Trajectory Changes of Coronary Sinus Lead Tip and Cardiac Resynchronization Therapy Outcome
NCT number | NCT02340546 |
Other study ID # | 1368/2014 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2015 |
Est. completion date | December 31, 2019 |
Verified date | March 2020 |
Source | Ospedale Santa Maria delle Croci |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
In chronic systolic heart failure patients submitted to cardiac resynchronization therapy, the study aims at assessing whether geometric variations in coronary sinus lead tip trajectory throughout the cardiac cycle acutely induced by biventricular pacing, are predictive of the volumetric and clinical response to the treatment at six-month follow-up.
Status | Completed |
Enrollment | 119 |
Est. completion date | December 31, 2019 |
Est. primary completion date | January 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Informed consent; 2. chronic systolic heart failure recognized for more than 6 months, with left ventricular systolic disfunction (ejection fraction = 35%) and NYHA II-III or ambulatory IV class symptoms despite optimal medical treatment; 3. QRS complex on the surface electrocardiogram with left bundle branch block morphology and duration = 120 ms, either typical or atypical or induced by right ventricular pacing due to stable chronic advanced atrio-ventricular block; QRS with with non-specific intraventricular delay lasting = 150 ms; 4. a regular ventricular rhythm, either with spontaneous atrio-ventricular conduction or with ventricular pacing via a chronically implanted antibradycardia device; with sinus rhythm unless atrial fibrillation is permanent and associated with a permanent high-degree atrio-ventricular block with a spontaneous ventricular rate constantly = 45 beats per minute; 5. no concomitant bradyarrhythmias being per se an indication for new implant ventricular pacing; upgrade to cardiac resynchronization therapy only if a previous pacemaker or implantable cardioverter-defibrillator was implanted more than 6 months previously; 6. a stable clinical and hemodynamic condition during cardiac resynchronization therapy device implant, and at the acquisition time heat rate between 50 and 100 beats per minute and respiratory rate = 25 breaths per minute; Exclusion Criteria: 1. inability to give informed consent; 2. occurrence of myocardial infarction, valve repair or surgery, or coronary revascularization in the past 6 months; 3. any arrhythmia at the acquisition time which frequently alters the regularity of a minimum of five consecutive heart beats; 4. participation in any other competing clinical study, with the exception of registries ruled by National Health Service Authorities or Agencies, and observational studies/registries which are not conflicting and do not interfere with any of the following aspects: 1. the program of procedures/assessments requested by the present study; 2. the outcome of the present study due to the requirement of medical treatments or interventions which are able to modify the clinical conditions of patients. |
Country | Name | City | State |
---|---|---|---|
Italy | Poiliclinico Sant'Orsola-Malpighi | Bologna | BO |
Italy | Ospedale Maurizio Bufalini | Cesena | FC |
Italy | Ospedale Mater Salutis | Legnago | Verona |
Italy | Ospedale Classificato Equiparato Sacro Cuore - Don Calabria - | Negrar | VR |
Italy | Ospedale Santa Maria delle Croci | Ravenna | RA |
Italy | Ospedale S Maria della Misericordia - AUSL 18 del Veneto | Rovigo | |
Italy | Ospedale San Bortolo | Vicenza |
Lead Sponsor | Collaborator |
---|---|
Corrado Tomasi | University of Bologna |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the two-dimensional echocardiographic volumetric response to cardiac resynchronization therapy | the volumetric response to cardiac resynchronization therapy defined by a reduction equal or greater than 15% in two-dimensional echocardiographic end-systolic volume (ml) at six-month in comparison with pre-implant assessment; | six months | |
Secondary | the clinical response to cardiac resynchronization therapy depicted by three metrics | the variations of three variables between pre-implant status and six-month follow-up, with no cut-off values: New York Heart Association functional class, from I to IV; distance covered at the six-minute walking test (in meters); total duration of hospital stay (number of days) due to heart failure in the 6 months before and after implant | six months |
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