CRyo-Ablation to Treat Patients With HOCM. (CRASH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01875016
Recruitment Status : Unknown
Verified June 2013 by MEDINA AHARON, Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 11, 2013
Last Update Posted : June 11, 2013
Information provided by (Responsible Party):
MEDINA AHARON, Shaare Zedek Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
HOCM, Hypertrophic Obstructive Cardiomyopathy Procedure: CRyo-Ablation to Treat HOCM. Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endocardial Catheter CRyo-Ablation of Septal Hypertrophy for Hypertrophic Obstructive Cardiomyopathy
Study Start Date : June 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : April 2015

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

Primary Outcome Measures :
  1. Acute and long term reduction of initial LVOT gradient [ Time Frame: Post procedure and up to 12 months follow up ]

Secondary Outcome Measures :
  1. Number of patients with procedure related complications. [ Time Frame: During the procedure untill discharge. ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Responsible Party: MEDINA AHARON, Head of EP Unit, Shaare Zedek Medical Center Identifier: NCT01875016     History of Changes
Other Study ID Numbers: CRASH
First Posted: June 11, 2013    Key Record Dates
Last Update Posted: June 11, 2013
Last Verified: June 2013

Keywords provided by MEDINA AHARON, Shaare Zedek Medical Center:
Cryo ablation

Additional relevant MeSH terms:
Cardiomyopathy, Hypertrophic
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases