A Phase 2 interventional study of Biventricular pacing and No Pacing in Hypertrophic Obstructive Cardiomyopathy (HOCM), sponsored by Hospital Clinic of Barcelona. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-20.
Sponsored by Hospital Clinic of Barcelona · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the benefit of the optimal pacing configuration, including the possibility of biventricular or left ventricular pacing, in hypertrophic obstructive cardiomyopathy patients.
In this study, subjects will be randomized to Cardiac Resynchronization Therapy-Defibrillation (CRT-D) or Cardiac Resynchronization Therapy-Pacing (CRT-P) vs Pacing Therapy AAI. Randomization will be stratified by indication. Optimal pharmacological therapy in both treatment arms. Length of follow-up for each subject will be 2y, since all subjects will be followed to a common study termination date.
1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.
This study's planned enrollment of 80 is above the median of 51 across 609 interventional studies indexed under Cardiomyopathies.
Browse Cardiomyopathies studies →Hospital Clinic of Barcelona is the lead sponsor of 319 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All patients will be pacing during two years
Device: Biventricular pacing
No Pacing during the first year. In the second year all patients will be pacing
Device: No Pacing
All patients will be pacing during two years
Also known as: CRT-D and CRT-P devices:, Promote Quadra CD3239-40, CD3239-40Q. St. Jude Medical, Promote Q CD3221-36. St. Jude Medical, Pacemaquer:, Anthem PM3112. St. Jude Medical
No Pacing during the first year. In the second year all patients will be pacing
Also known as: CRT-D and CRT-P devices:, Promote Quadra CD3239-40, CD3239-40Q. St. Jude Medical, Promote Q CD3221-36. St. Jude Medical, Pacemaquer:, Anthem PM3112. St. Jude Medical
Change from Baseline in Left ventricular mass and resting left ventricular outflow tract gradient (mmHg).
Change from Baseline in Left ventricular mass and resting left ventricular outflow tract gradient (mmHg)
Time frame: 1 and 2 years
Change from Baseline in Clinical evaluation of NYHA,QoL,6MWT,interventricular septum thickness,posterior wall thickness,provoked left ventricular outflow tract gradient,mitral regurgitation grade.
Change from Baseline in Clinical evaluation (New York Heart Association(NYHA), Quality of life Questionnaire (QoL), 6 Minutes Walk Test (6MWT)), interventricular septum thickness, posterior wall thickness, provoked left ventricular outflow tract gradient, mitral regurgitation grade.
Time frame: 1 and 2 years
This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Hospital Clinic of Barcelona