Radial Strain ECHO-Guided Implantation of Cardiac Resynchronization Therapy

Completed · Not applicable

Conditions studied: Ischemic Cardiomyopathy

In brief

The purpose of this study is to evaluate the use of radial strain imaging using speckle tracking analysis to predict the response to CRT in patients with ischemic cardiomyopathy (ICMP) with NYHA functional class 2-4 heart failure and a standard guideline-based CRT indication. Thus assessing the value of lead localization determined by radial strain imaging in a prospective, randomized manner.

Key facts

Study ID

NCT01603706

Run by

Sheba Medical Center

People needed

172

Starts

2012-05-01

Expected to finish

2017-10-01

Last updated by the study team

2017-10-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with ischemic CMP based on evidence of prior MI by history, coronary angiography/revascularization or imaging
• AHA ACC or ESC EHRA Guideline-based indication (Class I or II) for CRT and NYHA class II-IV heart failure
• ECG wide QRS and :
• QRS > 120 msec in NYHA III- IV
• OR
• CLBBB or QRS > 150 in NYHA =II
• Sinus rhythm predominant rhythm (PAF not an exclusion)
• All must be candidates for De novo CRT-D implantation with LV lead via transvenous approach or patients previously implanted with pacemaker or ICD with <20% pacing over the last three months who are undergoing CRT-D upgrade.
• Patient provides informed consent, tolerate a pectoral implant, agree to comply with the protocol, and maintain scheduled follow-up visits.

You may not qualify if…

• Permanent or persistent atrial fibrillation
• Advanced renal disease (Cr >=2.5 mg/dL)
• Advanced comorbidities with life expectancy of <1 year
• Patients on waiting list for heart transplantation
• Requiring intravenous amines (continuous or or intermittent amine drip therapy)
• Severe chronic pulmonary disease (simulating heart failure)
• Severe (untreated) organic mitral valve disease
• Poorly treated hypertension
• History of myocardial infarction < 3 months; unstable angina < 1m, CABG <3 months; PCI <3 months
• Mechanical TC valve
• Previously implanted CRT system
• Poorly visualized cardiac chamber dimensions in an echocardiogram performed prior to enrollment - please help us define
• Pregnancy or child-bearing potential in the absence of accepted forms of birth control
• Concurrent enrollment in other study

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States
• Barzilai Medical Center — Ashkelon, Israel
• Carmel Medical Center — Haifa, Israel
• Rambam Medical Center — Haifa, Israel
• Shaare Zedek — Jerusalem, Israel
• Rabin Medical Center — Petah Tikva, Israel
• Sheba Medical Center — Ramat Gan, Israel
• Kaplan Medical Center — Rehovot, Israel
• Sorasky Medical Center — Tel Aviv, Israel

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.