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

Primary Purpose

HOCM, Hypertrophic Obstructive Cardiomyopathy

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

CRyo-Ablation to Treat HOCM.

About this trial

This is an interventional treatment trial for HOCM, Hypertrophic Obstructive Cardiomyopathy focused on measuring Cryo ablation, Cardiomyopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The patient must be ≥18 years of age
The patient has left ventricular outflow tract obstruction with hypertrophic obstructive cardiomyopathy
The patient is on optimal medication
The patient is not eligible for/failed/refused alcohol ablation
The patient is not eligible for/failed/refused myectomy
The patient is willing to participate in the study and has signed informed consent
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:

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
Patient has history of or known impaired renal function (Serum creatinine >2.0 mg/dL or 177 µmol/l) or on dialysis
Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated
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
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)
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
Subjects meets the exclusion criteria required by local low (e.g. age, pregnancy, breast-feeding, etc)
Subject is anticipated not being able to complete the study

Sites / Locations

Outcomes

Primary Outcome Measures

Acute and long term reduction of initial LVOT gradient

Secondary Outcome Measures

Number of patients with procedure related complications.

Full Information

NCT ID

NCT01875016

First Posted

June 4, 2013

Last Updated

June 5, 2013

Sponsor

Shaare Zedek Medical Center

Collaborators

Medtronic

1. Study Identification

Unique Protocol Identification Number

NCT01875016

Brief Title

CRyo-Ablation to Treat Patients With HOCM.

Acronym

CRASH

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Unknown status

Study Start Date

June 2013 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shaare Zedek Medical Center

Collaborators

Medtronic

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HOCM, Hypertrophic Obstructive Cardiomyopathy

Keywords

Cryo ablation, Cardiomyopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

CRyo-Ablation to Treat HOCM.

Intervention Description

CRyo-Ablation to Treat Patients With HOCM.

Primary Outcome Measure Information:

Title

Acute and long term reduction of initial LVOT gradient

Time Frame

Post procedure and up to 12 months follow up

Secondary Outcome Measure Information:

Title

Number of patients with procedure related complications.

Time Frame

During the procedure untill discharge.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The patient must be ≥18 years of age The patient has left ventricular outflow tract obstruction with hypertrophic obstructive cardiomyopathy The patient is on optimal medication The patient is not eligible for/failed/refused alcohol ablation The patient is not eligible for/failed/refused myectomy The patient is willing to participate in the study and has signed informed consent 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: 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 Patient has history of or known impaired renal function (Serum creatinine >2.0 mg/dL or 177 µmol/l) or on dialysis Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated 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 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) 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 Subjects meets the exclusion criteria required by local low (e.g. age, pregnancy, breast-feeding, etc) Subject is anticipated not being able to complete the study

12. IPD Sharing Statement

Citations:

PubMed Identifier

17541123

Citation

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.

Results Reference

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PubMed Identifier

21272748

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.

Results Reference

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CRyo-Ablation to Treat Patients With HOCM.

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