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CompletedNCT01614717TRICHAMPIONUpdated Dec 21, 2020

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

An interventional study of CRT-P Implant in Hypertrophic Cardiomyopathy With Obstruction, sponsored by Abbott Medical Devices. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-21.

Sponsored by Abbott Medical Devices · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
Read the 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.
02

Conditions studied

  • Hypertrophic Cardiomyopathy With Obstruction

Keywords

  • Hypertrophic Obstructive Cardiomyopathy
  • Cardiac Resynchronization Therapy
03

In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's enrollment of 25 is below the median of 51 across 609 interventional studies indexed under Cardiomyopathies.

Browse Cardiomyopathies studies →

Lead sponsor

Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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).
  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.
  1. 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.
  1. Patients must be willing and able to comply with all study requirements.

Exclusion criteria

Exclusion Criteria:

  1. Known causes of cardiac hypertrophy as infiltrative cardiomyopathy, aortic stenosis and severe uncontrolled hypertension.
  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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
25 participants (actual)

Study arms

  • Active comparator
    Treatment Group

    CRT-P Implant. Patients randomized in Treatment Group will have the device programmed to optimized DDD pacing

    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

    Device: CRT-P Implant

Interventions

  • DeviceCRT-P Implant

    All patients will be implanted with a CRT-P device, then randomized to Treatment or Control Group

06

What researchers measure

Primary outcomes

  1. To evaluate the percentage of HOCM patients with severe LVOT obstruction implanted with a CRT-P device that have symptomatic improvement at 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).

    Time frame: 12 months

07

Study locations

1 site
  • Hospital Universitario Clinic I Provincial
    Barcelona, 08036, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01614717
Lead sponsor
Abbott Medical Devices
Responsible party
Sponsor
First posted
Jun 8, 2012
Start date
Jul 2014
Primary completion
Sep 2020
Completion
Sep 2020
Last update
Dec 21, 2020

Study contacts

Josep Brugada, Proffesor
principal investigator · Hospital Clinic I Provincial, Barcelona, Spain
Antonio Berruezo, Dr.
principal investigator · Hospital Clinic I Provincial, Barcelona, Spain

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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