Trials / Terminated
TerminatedNCT02006069
MOre REsponse on Cardiac Resynchronization Therapy With MultiPoint Pacing
MOre REsponse on Cardiac Resynchronization Therapy (CRT) With MultiPoint Pacing (MPP)
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 5,850 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this Clinical investigation is to assess the impact of the Multi Point Pacing (MPP) feature at 12 months in the treatment of patients not responding to standard Cardiac Resynchronization Therapy (CRT) after 6 months.
Detailed description
This study is designed as a prospective, randomized, multi-center trial. Data will be collected at enrollment, baseline, implant procedure, patient classification, 6 months and 12 months of follow-up. During the 6-month visit, the patient's response to CRT will be evaluated according to LVESV reduction. Patients with an LVESV reduction of at least 15% will be classified as responders. These patients will terminate their participation in the study and return to the center's standard practice. Patients with an LVESV reduction less than 15% will be classified as non-responders and the MPP feature will be activated according to randomization result and they will be followed until the 12-month visit.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MPP | All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature will be evaluated in two study phases. Patients randomized to MPP in Phase I will have MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II will have MPP programmed per protocol requirements ("mandated MPP programming"). |
Timeline
- Start date
- 2013-12-01
- Primary completion
- 2021-05-30
- Completion
- 2021-05-30
- First posted
- 2013-12-09
- Last updated
- 2023-05-17
- Results posted
- 2023-05-17
Locations
206 sites across 30 countries: United States, Australia, Austria, Belgium, Canada, China, Colombia, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Lebanon, Malaysia, Malta, Netherlands, Poland, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom
Source: ClinicalTrials.gov record NCT02006069. Inclusion in this directory is not an endorsement.