Triple Chamber Pacing in Hypertrophic Obstructive Cardiomyopathy (HOCM) Patients - TRICHAMPION STUDY (TRICHAMPION)
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ClinicalTrials.gov Identifier: NCT01614717 |
Recruitment Status
:
Recruiting
First Posted
: June 8, 2012
Last Update Posted
: May 1, 2017
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Tracking Information | |||||||
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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 |
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:
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Original Primary Outcome Measures ICMJE |
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.
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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
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Detailed Description | Data collection
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Study Type ICMJE | Interventional | ||||||
Study Phase | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single (Investigator) Primary Purpose: Treatment |
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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 |
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Study Arms |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
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:
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:
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Sex/Gender |
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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 |
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IPD Sharing Statement |
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Responsible Party | St. Jude Medical | ||||||
Study Sponsor ICMJE | St. Jude Medical | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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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 |