HOCM, Hypertrophic Obstructive CardiomyopathyCRASHNCT01875016
CRyo-Ablation to Treat Patients With HOCM.
A study testing CRyo-Ablation to Treat HOCM. in people with HOCM, Hypertrophic Obstructive Cardiomyopathy, run by Shaare Zedek Medical Center.
Trial summary
The purpose of the study is to perform endocardial catheter CRyo-Ablation to relieve the LVOT obstruction in patients with Hypertrophic Obstructive Cardiomyopathy. The investigators hypothesize that the investigators will be able to reduce > 50% of the initial LVOT gradient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HOCM, Hypertrophic Obstructive Cardiomyopathy
- What is being tested?
- CRyo-Ablation to Treat HOCM.
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Apr 2015
- 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
- The patient must be ≥18 years of age
- The patient has left ventricular outflow tract obstruction with hypertrophic obstructive cardiomyopathy
- The patient is on optimal medication
- The patient is not eligible for/failed/refused alcohol ablation
- The patient is not eligible for/failed/refused myectomy
- The patient is willing to participate in the study and has signed informed consent
- The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved be the appropriate medical ethics committee.
Who cannot join
- Pregnant or nursing patients Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test
- Patient has history of or known impaired renal function (Serum creatinine >2.0 mg/dL or 177 µmol/l) or on dialysis
- Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated
- Patient has a known hypersensivity or contraindication to aspirin, both heparin and bivalirudin, clopidogrel and/or contrast sensitivity/allergy that cannot be adequately pre-medicated
- Patient has other medical illness not related to the hypertrophic cardiomyopathy (e.g., cancer, known malignancy, or cognitive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with limited life expectancy (i.e., less than 1 year)
- Subject is enrolled or intended to participate in any concurrent drug and/or device study, which would confound the results of this trial as determined by the investigator, during the course of this clinical study
- Subjects meets the exclusion criteria required by local low (e.g. age, pregnancy, breast-feeding, etc)
- Subject is anticipated not being able to complete the study
About this study
Official title: Endocardial Catheter CRyo-Ablation of Septal Hypertrophy for Hypertrophic Obstructive Cardiomyopathy
The purpose of the study is to perform endocardial catheter CRyo-Ablation to relieve the LVOT obstruction in patients with Hypertrophic Obstructive Cardiomyopathy.
The investigators hypothesize that the investigators will be able to reduce > 50% of the initial LVOT gradient. This will be considered as a successful procedure.
- Being tested
- CRyo-Ablation to Treat HOCM.
- Keywords
- Cryo ablation, Cardiomyopathy
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRyo-Ablation to Treat HOCM.Procedure or surgery
CRyo-Ablation to Treat Patients With HOCM.
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute and long term reduction of initial LVOT gradient
Measured: Post procedure and up to 12 months follow up
Secondary outcomes (1)
Number of patients with procedure related complications.
Measured: During the procedure untill discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2014 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HOCM, Hypertrophic Obstructive CardiomyopathyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, MEDINA AHARON, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875016
- Sponsor's protocol ID
- CRASH
- Acronym
- CRASH
- Status last verified
- Jun 2013
- First submitted
- 4 Jun 2013
- Last updated
- 11 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Keane D, Hynes B, King G, Shiels P, Brown A. Feasibility study of percutaneous transvalvular endomyocardial cryoablation for the treatment of hypertrophic obstructive cardiomyopathy. J Invasive Cardiol. 2007 Jun;19(6):247-51.
PubMed 17541123Lawrenz T, Borchert B, Leuner C, Bartelsmeier M, Reinhardt J, Strunk-Mueller C, Meyer Zu Vilsendorf D, Schloesser M, Beer G, Lieder F, Stellbrink C, Kuhn H. Endocardial radiofrequency ablation for hypertrophic obstructive cardiomyopathy: acute results and 6 months' follow-up in 19 patients. J Am Coll Cardiol. 2011 Feb 1;57(5):572-6. doi: 10.1016/j.jacc.2010.07.055.
PubMed 21272748
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocardial Catheter CRyo-Ablation of Septal Hypertrophy for Hypertrophic Obstructive Cardiomyopathy
- ClinicalTrials.gov ID
- NCT01875016
- Acronym / sponsor ID
- CRASH / CRASH
- Keywords
- Cryo ablation, Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 11 Jun 2013 (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.
The purpose of the study is to perform endocardial catheter CRyo-Ablation to relieve the LVOT obstruction in patients with Hypertrophic Obstructive Cardiomyopathy.
The investigators hypothesize that the investigators will be able to reduce > 50% of the initial LVOT gradient. This will be considered as a successful procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient must be ≥18 years of age
- The patient has left ventricular outflow tract obstruction with hypertrophic obstructive cardiomyopathy
- The patient is on optimal medication
- The patient is not eligible for/failed/refused alcohol ablation
- The patient is not eligible for/failed/refused myectomy
Key exclusion criteria (8 listed)
- Pregnant or nursing patients Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test
- Patient has history of or known impaired renal function (Serum creatinine >2.0 mg/dL or 177 µmol/l) or on dialysis
- Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated
- Patient has a known hypersensivity or contraindication to aspirin, both heparin and bivalirudin, clopidogrel and/or contrast sensitivity/allergy that cannot be adequately pre-medicated
- Patient has other medical illness not related to the hypertrophic cardiomyopathy (e.g., cancer, known malignancy, or cognitive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with limited life expectancy (i.e., less than 1 year)
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 |
|---|---|---|
| CRyo-Ablation to Treat HOCM.CRyo-Ablation to Treat Patients With HOCM. | Procedure or surgery | – |
Primary outcome
Acute and long term reduction of initial LVOT gradient
Time frame: Post procedure and up to 12 months follow up
1 secondary outcome
Number of patients with procedure related complications.
Time frame: During the procedure untill discharge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2013.
- Background: PubMed 17541123Keane D, Hynes B, King G, Shiels P, Brown A. Feasibility study of percutaneous transvalvular endomyocardial cryoablation for the treatment of hypertrophic obstructive cardiomyopathy. J Invasive Cardiol. 2007 Jun;19(6):247-51.
- Background: PubMed 21272748Lawrenz T, Borchert B, Leuner C, Bartelsmeier M, Reinhardt J, Strunk-Mueller C, Meyer Zu Vilsendorf D, Schloesser M, Beer G, Lieder F, Stellbrink C, Kuhn H. Endocardial radiofrequency ablation for hypertrophic obstructive cardiomyopathy: acute results and 6 months' follow-up in 19 patients. J Am Coll Cardiol. 2011 Feb 1;57(5):572-6. doi: 10.1016/j.jacc.2010.07.055.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CRyo-Ablation to Treat HOCM. in people with HOCM, Hypertrophic Obstructive Cardiomyopathy, run by Shaare Zedek Medical Center.
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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 11 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
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?
Acute and long term reduction of initial LVOT gradient (time frame: Post procedure and up to 12 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01875016, which also lists 2 linked publications.
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 11 Jun 2013.