Radial Strain Imaging-Guided Lead Placement for Improving Response to Cardiac Resynchronization Therapy in Patients With Ischemic Cardiomyopathy: A Randomized Clinical Trial

Status: Completed
Location: See all (9) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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.

Locations
United States
Minnesota
Mayo Clinic
Rochester
Other Locations
Israel
Barzilai Medical Center
Ashkelon
Carmel Medical Center
Haifa
Rambam Medical Center
Haifa
Shaare Zedek
Jerusalem
Rabin Medical Center
Petah Tikva
Sheba Medical Center
Ramat Gan
Kaplan Medical Center
Rehovot
Sorasky Medical Center
Tel Aviv
Time Frame
Start Date: May 2012
Completion Date: October 2017
Participants
Target number of participants: 172
Treatments
Active Comparator: Echo guided implantation group
Echo guided implantation group Patients undergoing speckle tracking based LV lead implantation.
No Intervention: Conventional implantation group
Patients undergoing conventional LV lead implantation
Related Therapeutic Areas
Sponsors
Collaborators: Mayo Clinic, Soroka University Medical Center, Rabin Medical Center, Rambam Health Care Campus, Kaplan Medical Center, Tel-Aviv Sourasky Medical Center
Leads: Sheba Medical Center

This content was sourced from clinicaltrials.gov