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
  Purpose

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 Intervention
HOCM, Hypertrophic Obstructive Cardiomyopathy
Procedure: CRyo-Ablation to Treat HOCM.

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endocardial Catheter CRyo-Ablation of Septal Hypertrophy for Hypertrophic Obstructive Cardiomyopathy

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Number of patients with procedure related complications. [ Time Frame: During the procedure untill discharge. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: June 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: CRyo-Ablation to Treat HOCM.
    CRyo-Ablation to Treat Patients With HOCM.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: MEDINA AHARON, Head of EP Unit, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT01875016     History of Changes
Other Study ID Numbers: CRASH
Study First Received: June 4, 2013
Last Updated: June 5, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Shaare Zedek Medical Center:
Cryo ablation
Cardiomyopathy

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

ClinicalTrials.gov processed this record on July 22, 2014