Hypertrophic Cardiomyopathy With ObstructionTRICHAMPIONNCT01614717
Triple Chamber Pacing in Hypertrophic Obstructive Cardiomyopathy (HOCM) Patients - TRICHAMPION STUDY
A study testing CRT-P Implant in people with Hypertrophic Cardiomyopathy With Obstruction, run by Abbott Medical Devices at 1 site in Spain.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy With Obstruction
- What is being tested?
- CRT-P Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2014to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- CRT-P Implant
- Keywords
- Hypertrophic Obstructive Cardiomyopathy, Cardiac Resynchronization Therapy
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT-P ImplantDevice
All patients will be implanted with a CRT-P device, then randomized to Treatment or Control Group
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Active comparator | CRT-P Implant. Patients randomized in Treatment Group will have the device programmed to optimized DDD pacing Receives: 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 Receives: Device: CRT-P Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startJul 2014
- Primary completionSep 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic Cardiomyopathy With ObstructionStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Josep Brugada, Proffesor, Principal investigator, Hospital Clinic I Provincial, Barcelona, SpainAntonio Berruezo, Dr., Principal investigator, Hospital Clinic I Provincial, Barcelona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614717
- Sponsor's protocol ID
- CR-11-030-EU-HF
- Acronym
- TRICHAMPION
- Status last verified
- Dec 2020
- First submitted
- 6 Jun 2012
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triple Chamber Pacing in HOCM Patients - TRICHAMPION STUDY
- ClinicalTrials.gov ID
- NCT01614717
- Acronym / sponsor ID
- TRICHAMPION / CR-11-030-EU-HF
- Keywords
- Hypertrophic Obstructive Cardiomyopathy, Cardiac Resynchronization Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jul 2014 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 8 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Active comparator | Device: CRT-P ImplantCRT-P Implant. Patients randomized in Treatment Group will have the device programmed to optimized DDD pacing |
| Control Group | Placebo comparator | Device: CRT-P ImplantCRT-P Implant. Patients randomized in the control Group will have the device programmed to back-up pacing AAI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRT-P ImplantAll patients will be implanted with a CRT-P device, then randomized to Treatment or Control Group | Device | Control Group, Treatment Group |
Primary outcome
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
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josep Brugada, Proffesor principal investigator
Hospital Clinic I Provincial, Barcelona, Spain
Antonio Berruezo, Dr. principal investigator
Hospital Clinic I Provincial, Barcelona, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRT-P Implant in people with Hypertrophic Cardiomyopathy With Obstruction, run by Abbott Medical Devices at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020.