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

Triple Chamber Pacing in 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.

Study Overview

• Status: Completed
• Conditions: Hypertrophic Cardiomyopathy With Obstruction
• Intervention / Treatment: Device: CRT-P Implant

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Universitario Clinic i Provincial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Josep Brugada, Proffesor, Hospital Clinic i Provincial, Barcelona, Spain; Principal Investigator: Antonio Berruezo, Dr., Hospital Clinic i Provincial, Barcelona, Spain

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: June 6, 2012
• First Submitted That Met QC Criteria: June 6, 2012
• First Posted (Estimate): June 8, 2012

Study Record Updates

• Last Update Posted (Actual): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 18, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Cardiac Resynchronization Therapy; Hypertrophic Obstructive Cardiomyopathy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Hypertrophy; Cardiomyopathies; Cardiomyopathy, Hypertrophic
• Other Study ID Numbers: CR-11-030-EU-HF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No