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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by Shaare Zedek Medical Center
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
MEDINA AHARON, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT01875016
First received: June 4, 2013
Last updated: June 5, 2013
Last verified: June 2013

June 4, 2013
June 5, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01875016 on ClinicalTrials.gov Archive Site
Number of patients with procedure related complications. [ Time Frame: During the procedure untill discharge. ] [ Designated as safety issue: Yes ]
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
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Not yet recruiting
15
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
Both
18 Years and older
No
Not Provided
 
NCT01875016
CRASH
No
MEDINA AHARON, Shaare Zedek Medical Center
Shaare Zedek Medical Center
Medtronic
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