Triple Chamber Pacing in Hypertrophic Obstructive Cardiomyopathy (HOCM) Patients - TRICHAMPION STUDY (TRICHAMPION)

Tracking Information
First Submitted Date ICMJE	June 6, 2012
First Posted Date ICMJE	June 8, 2012
Last Update Posted Date	May 1, 2017
Study Start Date ICMJE	July 2014
Estimated Primary Completion Date	July 2019 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 18, 2014)	To evaluate the percentage of HOCM patients with severe LVOT obstruction implanted with a CRT-P device that have symptomatic improvement at 12 months. [ Time Frame: 12 months ]; The primary endpoint of the study is to evaluate the percentage of HOCM patients with severe LVOT obstruction implanted with a CRT-P device that have symptomatic improvement at 12 months post-implant. The symptomatic improvement is a combined endpoint defined as: An improvement of at least one New Yorl Heart Association (NYHA) functional class and; An improvement of 10 points in the Quality of Life (QoL) Questionnaire score and; An increase >10% in bike exercise time in the steady state Cardiopulmonary Exercise Test (CPET).
Original Primary Outcome Measures ICMJE; (submitted: June 6, 2012)	To Evaluate the Reverse Remodeling at 12 months post Implant [ Time Frame: 12 months ]; The primary objective of the study is to evaluate the reverse remodeling due to a decrease in the LV mass (gr) associated to a reduction in resting LVOT gradient (mmHg) in hypertrophic obstructive cardiomyopathy patients with severe LVOT obstruction implanted with a CRT device at 12 months post-implant.
Change History	Complete list of historical versions of study NCT01614717 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Triple Chamber Pacing in Hypertrophic Obstructive Cardiomyopathy (HOCM) Patients - TRICHAMPION STUDY
Official Title ICMJE	Triple Chamber Pacing in HOCM Patients - TRICHAMPION STUDY
Brief Summary	This investigation is a prospective, randomized, single-blinded and multicenter design. The purpose of this study is to evaluate the benefit of atrial-synchronous biventricular (BiV) pacing in severely symptomatic hypertrophic obstructive cardiomyopathy (HOCM) patients with severe Left Ventricular Outflow Tract (LVOT) obstruction implanted with a Cardiac Resynchronization Therapy - Pacing (CRT-P) device. Randomization; Implant will be performed (CRT-P).; Patients will be randomized 1:1 to either Treatment Group (Optimized Biventricular (DDD) pacing) or Control Group (Back-up Atrial (AAI) pacing) during the first 12 months:; Treatment Group. The patient´s device is programmed to optimized DDD BiV pacing; Control Group. The patient´s device is programmed to back-up pacing AAI.; After 12 months, the patients initially randomized to the Treatment Group (Optimized DDD Pacing) will continue in the same group. The patients initially randomized to Control Group (AAI Back-up Pacing) will be changed to the Treatment Group (Optimized DDD Pacing). And all the patients will be followed 12 months more.
Detailed Description	Data collection; In clinic Follow ups (FU): Enrollment, Baseline, Implant, Pre-discharge, 3 months (M), 12 M, 15 M and 24 M.; Phone call FU: 6 M, 9 M, 18 M and 21 M.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Investigator); Primary Purpose: Treatment
Condition ICMJE	Hypertrophic Cardiomyopathy With Obstruction
Intervention ICMJE	Device: CRT-P Implant; All patients will be implanted with a CRT-P device, then randomized to Treatment or Control Group
Study Arms	Active Comparator: Treatment Group CRT-P Implant. Patients randomized in Treatment Group will have the device programmed to optimized DDD pacing Intervention: Device: CRT-P Implant; Placebo Comparator: Control Group CRT-P Implant. Patients randomized in the control Group will have the device programmed to back-up pacing AAI Intervention: Device: CRT-P Implant
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: June 6, 2012)	80
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	July 2019
Estimated Primary Completion Date	July 2019 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Unequivocal diagnosis of hypertrophic cardiomyopathy (HCM), on the basis of 2-dimensional echocardiographic demonstration of a hypertrophied (wall thickness ≥15 mm) and nondilated Left Ventricle (Left Ventricle End Diastolic Diameter (LVEDD) < 55mm) confirmed by a Core Lab Echo (Appendix I).; Significant resting (not provoked) LV outflow tract obstruction, on the basis of peak LVOT gradient ≥50 mmHg, estimated by continuous wave Doppler and confirmed by a Core Lab Echo (Appendix I).; Presence of refractory symptoms (exertional dyspnea or chest pain) despite of optimal treatment with betablockers and/or verapamil for at least 3 months (NYHA class >II).; Patients that refuse or have contraindication for septal myectomy or septal ablation (i.e., comorbidity, inappropriate coronary anatomy for septal ablation), that prefer cardiac pacing, or that are at high risk for developing heart block following septal myectomy or septal ablation. 6. Patient's age is 18 years or greater. 7. Patients must indicate their understanding of the study and willingness to participate by signing the appropriate informed consent form. 8. Patients must be willing and able to comply with all study requirements. Exclusion Criteria: Known causes of cardiac hypertrophy as infiltrative cardiomyopathy, aortic stenosis and severe uncontrolled hypertension.; Permanent or persistent atrial fibrillation.; Previous septal myectomy or septal ablation.; Any indication for permanent pacing, except for HOCM.; Any indication for an Implantable Cardioverter Defibrillator (ICD).; Systemic disease that would preclude completion of the protocol.; Any disability or limitations to correctly understand or complete the study (physical, intellectual, logistical).; Patients with a life expectancy <24 months (based on investigator assessment).; Patients who are or may potentially be pregnant.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE
Listed Location Countries ICMJE	Spain
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01614717
Other Study ID Numbers ICMJE	CR-11-030-EU-HF
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement	Plan to Share IPD: No
Responsible Party	St. Jude Medical
Study Sponsor ICMJE	St. Jude Medical
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Josep Brugada, Proffesor Hospital Clinic I Provincial, Barcelona, Spain Principal Investigator: Antonio Berruezo, Dr. Hospital Clinic I Provincial, Barcelona, Spain
PRS Account	St. Jude Medical
Verification Date	April 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP