Triple Chamber Pacing in HOCM Patients - TRICHAMPION STUDY

This study is not yet open for participant recruitment.
Verified June 2013 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 4, 2013
Last verified: June 2013
  Purpose

This investigation is a prospective, randomized, parallel, blinded and multicenter design.

Randomization

  • Implant will be performed (Cardiac Resynchronization Therapy - Pacing (CRT-P) or Cardiac Resynchronization Therapy - Defibrillator (CRT-D)). according current international certified guidelines.
  • Randomization will be stratified by the type of the device implanted (CRT-D or CRT-P)
  • Patients will be randomized 1:1 to either Treatment Group (Optimized DDD pacing) or Control Group (Back-up AAI pacing) during the first 12 months:
  • Treatment Group. The patient´s device is programmed to optimized DDD 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 go on 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.
  • The Echo Core Lab will be blinded to the group assigned.

Condition Intervention
Focus on Symptomatic Hypertrophic Obstructive Cardiomyopathy With Severe LVOT Obstruction
Device: CRT Implant

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
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 Reverse Remodeling at 12 months post Implant [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: August 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment Group
Patients randomized in Treatment Group will have the device programmed to optimized DDD pacing
Device: CRT Implant
Patients will be implanted with CRT-D or CRT-P devices, then randomized to Treatment or Control Group
Control Group
Patients randomized in the control Group will have the device programmed to back-up pacing AAI
Device: CRT Implant
Patients will be implanted with CRT-D or CRT-P devices, then randomized to Treatment or Control Group

  Eligibility

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

Inclusion Criteria:

  • Unequivocal diagnosis of HCM, on the basis of 2-dimensional echocardiographic demonstration of a hypertrophied (wall thickness ≥15 mm) and nondilated LV (LVEDD < 55mm) confirmed by a Core Lab Echo (Appendix I)
  • Peak LVOT gradient ≥50 mmHg under basal conditions, estimated by continuous wave Doppler, confirmed by a Core Lab Echo (Appendix I)
  • Presence of refractory symptoms (exertional dyspnea or chest pain) despite treatment with betablockers and/or verapamil (NYHA class II, III or IV).
  • Patients age is 18 years or greater
  • 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 and severe hypertension
  • Permanent or persistent atrial fibrillation
  • Prior septal myectomy or septal ablation
  • Established indications for permanent pacing
  • Systemic disease that would preclude completion of the protocol
  • Limitations to correctly complete the study (physical, intellectual, logistical)
  • Patients with a life expectancy <24 months.
  • Patients who are or may potentially be pregnant.
  Contacts and Locations
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, Prof.         
Sponsors and Collaborators
St. Jude Medical
  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 4, 2013
Health Authority: Spain: Ethics Committee

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

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

ClinicalTrials.gov processed this record on April 15, 2014