CRyo-Ablation to Treat Patients With HOCM. (CRASH)
|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
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)|
|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|
Procedure: CRyo-Ablation to Treat HOCM.
- Acute and long term reduction of initial LVOT gradient [ Time Frame: Post procedure and up to 12 months follow up ]
- Number of patients with procedure related complications. [ Time Frame: During the procedure untill discharge. ]