We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov 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):

June 4, 2013
June 11, 2013
June 11, 2013
June 2013
December 2014   (Final data collection date for primary outcome measure)
Acute and long term reduction of initial LVOT gradient [ Time Frame: Post procedure and up to 12 months follow up ]
Same as current
No Changes Posted
Number of patients with procedure related complications. [ Time Frame: During the procedure untill discharge. ]
Same as current
Not Provided
Not Provided
CRyo-Ablation to Treat Patients With HOCM.
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.

Not Provided
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
HOCM, Hypertrophic Obstructive Cardiomyopathy
Procedure: CRyo-Ablation to Treat HOCM.
CRyo-Ablation to Treat Patients With HOCM.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
April 2015
December 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
MEDINA AHARON, Shaare Zedek Medical Center
Shaare Zedek Medical Center
Not Provided
Shaare Zedek Medical Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP