CRyo-Ablation to Treat Patients With HOCM.

HOCM, Hypertrophic Obstructive Cardiomyopathy Clinical Trial

— CRASH  

Official title:

Endocardial Catheter CRyo-Ablation of Septal Hypertrophy for Hypertrophic Obstructive Cardiomyopathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01875016
• Other study ID #: CRASH
• Status: Not yet recruiting
• Phase: N/A
• First received: June 4, 2013
• Last updated: June 5, 2013
• Start date: June 2013
• Est. completion date: April 2015

Study information

• Verified date: June 2013
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical 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. This will be considered as a successful procedure.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: April 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The patient must be =18 years of age

2. The patient has left ventricular outflow tract obstruction with hypertrophic obstructive cardiomyopathy

3. The patient is on optimal medication

4. The patient is not eligible for/failed/refused alcohol ablation

5. The patient is not eligible for/failed/refused myectomy

6. The patient is willing to participate in the study and has signed informed consent

7. 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.

Exclusion Criteria:

1. 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

2. Patient has history of or known impaired renal function (Serum creatinine >2.0 mg/dL or 177 µmol/l) or on dialysis

3. Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated

4. 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

5. 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)

6. 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

7. Subjects meets the exclusion criteria required by local low (e.g. age, pregnancy, breast-feeding, etc)

8. Subject is anticipated not being able to complete the study

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• HOCM, Hypertrophic Obstructive Cardiomyopathy
• Hypertrophy

Intervention

Procedure:
• CRyo-Ablation to Treat HOCM.
CRyo-Ablation to Treat Patients With HOCM.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center	Medtronic

References & Publications (2)

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. — View Citation

Lawrenz 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute and long term reduction of initial LVOT gradient		Post procedure and up to 12 months follow up	No
Secondary	Number of patients with procedure related complications.		During the procedure untill discharge.	Yes