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

Primary Purpose

Hypertrophic Cardiomyopathy With Obstruction

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

CRT-P Implant

About this trial

This is an interventional treatment trial for Hypertrophic Cardiomyopathy With Obstruction focused on measuring Hypertrophic Obstructive Cardiomyopathy, Cardiac Resynchronization Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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:

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.

Sites / Locations

Hospital Universitario Clinic I Provincial

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment Group

Control Group

Arm Description

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

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

Outcomes

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.

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT01614717

First Posted

June 6, 2012

Last Updated

December 18, 2020

Sponsor

Abbott Medical Devices

1. Study Identification

Unique Protocol Identification Number

NCT01614717

Brief Title

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

Acronym

TRICHAMPION

Official Title

Triple Chamber Pacing in HOCM Patients - TRICHAMPION STUDY

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

July 2014 (Actual)

Primary Completion Date

September 2020 (Actual)

Study Completion Date

September 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abbott Medical Devices

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertrophic Cardiomyopathy With Obstruction

Keywords

Hypertrophic Obstructive Cardiomyopathy, Cardiac Resynchronization Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Control Group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

CRT-P Implant

Intervention Description

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

Primary Outcome Measure Information:

Title

To evaluate the percentage of HOCM patients with severe LVOT obstruction implanted with a CRT-P device that have symptomatic improvement at 12 months.

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. 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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Josep Brugada, Proffesor

Organizational Affiliation

Hospital Clinic I Provincial, Barcelona, Spain

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Antonio Berruezo, Dr.

Organizational Affiliation

Hospital Clinic I Provincial, Barcelona, Spain

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universitario Clinic I Provincial

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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