Triple Chamber Pacing in Hypertrophic Obstructive Cardiomyopathy (HOCM) Patients - TRICHAMPION STUDY
NCT ID: NCT01614717
Last Updated: 2020-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2014-07-31
2020-09-30
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Treatment Group
CRT-P Implant. Patients randomized in Treatment Group will have the device programmed to optimized DDD pacing
CRT-P Implant
All patients will be implanted with a CRT-P device, then randomized to Treatment or Control Group
Control Group
CRT-P Implant. Patients randomized in the control Group will have the device programmed to back-up pacing AAI
CRT-P Implant
All patients will be implanted with a CRT-P device, then randomized to Treatment or Control Group
Interventions
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CRT-P Implant
All patients will be implanted with a CRT-P device, then randomized to Treatment or Control Group
Eligibility Criteria
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Inclusion Criteria
2. 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).
3. 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).
4. 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
2. Permanent or persistent atrial fibrillation.
3. Previous septal myectomy or septal ablation.
4. Any indication for permanent pacing, except for HOCM.
5. Any indication for an Implantable Cardioverter Defibrillator (ICD).
6. Systemic disease that would preclude completion of the protocol.
7. Any disability or limitations to correctly understand or complete the study (physical, intellectual, logistical).
8. Patients with a life expectancy \<24 months (based on investigator assessment).
9. Patients who are or may potentially be pregnant.
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Josep Brugada, Proffesor
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic I Provincial, Barcelona, Spain
Antonio Berruezo, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic I Provincial, Barcelona, Spain
Locations
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Hospital Universitario Clinic I Provincial
Barcelona, , Spain
Countries
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Other Identifiers
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CR-11-030-EU-HF
Identifier Type: -
Identifier Source: org_study_id