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

NCT01614717 | Completed

• 1 other identifier: CR-11-030-EU-HF
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertrophic Cardiomyopathy With Obstruction

Keywords

Hypertrophic Obstructive Cardiomyopathy; Cardiac Resynchronization Therapy

Outcome Measures

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).

  12 months

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

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

Device: CRT-P Implant

Control Group

PLACEBO COMPARATOR

CRT-P Implant. Patients randomized in the control Group will have the device programmed to back-up pacing AAI

Device: CRT-P Implant

Interventions

CRT-P Implant DEVICE

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

Control Group; Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Hospital Universitario Clinic I Provincial

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Josep Brugada, Proffesor

  Hospital Clinic I Provincial, Barcelona, Spain

  PRINCIPAL INVESTIGATOR

• Antonio Berruezo, Dr.

  Hospital Clinic I Provincial, Barcelona, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: June 8, 2012
• Study Start: July 1, 2014
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)