This trial is active, not recruiting.

Condition heart failure
Treatments multipoint pacing, traditional biventricular pacing
Phase phase 3
Sponsor St. Jude Medical
Start date April 2013
End date April 2015
Trial size 506 participants
Trial identifier NCT01786993, 60029161/D


This IDE study is a prospective, randomized, double-blind, multi-center clinical study to evaluate the safety and efficacy of patient treatment with multi-point pacing compared to patient treatment with standard Biventricular pacing at 9 months.

The study will be conducted at a maximum of 50 investigational centers located in the United States. A maximum of 506 patients implanted with the Quadripolar cardiac resynchronization therapy device (CRT-D) system will be enrolled in the study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
MultiPoint Pacing
multipoint pacing
(Active Comparator)
Traditional Biventricular Pacing
traditional biventricular pacing

Primary Outcomes

Freedom from system-related complications
time frame: 9-Month
Percentage of non-responders with multi-point pacing compared to biventricular pacing
time frame: 9-Month

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Meets current clinical indication for implantation of a cardiac resynchronization therapy system for treatment of heart failure or life-threatening ventricular tachyarrhythmia(s) - Receiving a new CRT implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement - Have the ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations Exclusion Criteria: - Have had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months of enrollment - Have an existing Class I recalled lead - Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate - Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 9 months - Have permanent atrial fibrillation (AF) - Have undergone a cardiac transplantation within 40 days of enrollment - Have had a recent myocardial infarction, unstable angina within 40 days or cardiac revascularization within 3 months of implant. - Are currently participating in a clinical investigation that includes an active treatment arm - Are pregnant or planning to become pregnant during the duration of the study - Have a life expectancy of less than 9 months due to any condition - Are less than 18 years of age

Additional Information

Official title MultiPoint Pacing IDE Study
Principal investigator Gery Tomassoni, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by St. Jude Medical.