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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01614717
First received: June 6, 2012
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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.

Condition Intervention
Hypertrophic Cardiomyopathy With Obstruction
Device: CRT-P Implant

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Triple Chamber Pacing in HOCM Patients - TRICHAMPION STUDY

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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).


Estimated Enrollment: 80
Study Start Date: July 2014
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
All patients will be implanted with a CRT-P device, then randomized to Treatment or Control Group
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
All patients will be implanted with a CRT-P device, then randomized to Treatment or Control Group

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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) or prefer cardiac pacing.
  5. Patients 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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614717

Locations
Spain
Hospital Universitario Clinic I Provincial Not yet recruiting
Barcelona, Spain, 08036
Contact: Josep Brugada, Proffesor    (0034) 932 27 54 00      
Contact: Antonio Berruezo, Dr.    (0034) 932 27 54 00      
Principal Investigator: Antonio Berruezo, Dr.         
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Josep Brugada, Proffesor Hospital Clinic I Provincial, Barcelona, Spain
Principal Investigator: Antonio Berruezo, Dr. Hospital Clinic I Provincial, Barcelona, Spain
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01614717     History of Changes
Other Study ID Numbers: CR-11-030-EU-HF
Study First Received: June 6, 2012
Last Updated: June 25, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Switzerland: Swissmedic
Netherlands: Dutch Health Care Inspectorate

Keywords provided by St. Jude Medical:
Hypertrophic Obstructive Cardiomyopathy
Cardiac Resynchronization Therapy

Additional relevant MeSH terms:
Cardiomyopathy, Hypertrophic
Hypertrophy
Cardiomyopathy, Hypertrophic, Familial
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Pathological Conditions, Anatomical
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on August 19, 2014