This trial is active, not recruiting.

Conditions heart failure., an approved indication per acc/aha/hrs guidelines for implantation of a cardiac resynchronization therapy defibrillator
Treatment this is an observational study. no intervention
Sponsor Johns Hopkins University
Start date December 2011
End date January 2021
Trial size 70 participants
Trial identifier NCT01924221, NA_00065477, RER CRT


Cardiac resynchronization therapy with pacemaker alone, or in combination with a cardioverter-defibrillator, prolongs life and decreases risk of heart failure exacerbation in patients with low ejection fraction and wide QRS. Some patients achieve decrease in QRS duration 6 months after cardiac resynchronization therapy. Such fenomenon is called reverse electrical remodeling of native conduction. Retrospective analysis showed that reverse electrical remodeling of the native conduction after at least 6 months of CRT is associated with decreased rate of ventricular arrhythmias and better survival. This study is designed to study reverse electrical remodeling prospectively.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Patients with implanted cardiac resynchronization therapy defibrillator
this is an observational study. no intervention

Primary Outcomes

Sustained ventricular tachyarrhythmias
time frame: 10 years

Secondary Outcomes

Heart Failure Hospitalizations
time frame: 10 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - an approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D Exclusion Criteria: - age < 18 y - pregnancy or planned pregnancy

Additional Information

Official title Study of Reverse Electrical Remodeling of Native Conduction in Cardiac Resynchronization Therapy
Principal investigator Larisa Tereshchenko, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Johns Hopkins University.