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

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.

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Key information

Conditions

Hypertrophic Cardiomyopathy With Obstruction Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Clinic I Provincial

Barcelona, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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.

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.

Treatment and study plan

CRT-P Implant

Device

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

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Triple Chamber Pacing in HOCM Patients - TRICHAMPION STUDY

Acronym: TRICHAMPION

Important dates

Study start: 2014
Primary completion: 2020
Study completion: 2020
First posted: Jun 8, 2012
Registry last updated: Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed