Optimal Pacing Rate for Cardiac Resynchronization Therapy
Part of paid clinical trials in Washington D.C., District of Columbia.
- Sponsor
- Medstar Health Research Institute
- Study ID
- NCT06445439
- Status
- Recruiting
Conditions
- Atrial Fibrillation, Persistent
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 90 Years
- Healthy Volunteers
- Not accepted
Interventions
- Pacing rate of 80 bpm — DEVICEPacing rate of 80 bpm
- Pacing rate of 60 bpm — DEVICEPacing rate of 60 bpm
Study Details
This is a prospective, randomized crossover study. The objective of the study is to determine if a pacing rate of 80 beats per minute (bpm) improves exercise tolerance during the 6-minute walk test. The investigators will randomly assign half of the participants to a starting rate of 60 bpm and then switch them to a rate of 80 bpm for 3 months, and vice versa.
Key Dates
- Start date
- Dec 19, 2023
- Status verified
- Aug 2024
- Primary completion
- Aug 31, 2025
- Completion
- Aug 31, 2025
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Experimental: 60 bpm, then 80 bpmPacing rate of 60 bpm for the first 3 months, then switch to 80 bpm for the next 3 months.
- Experimental: 80 bpm, then 60 bpmPacing rate of 80 bpm for the first 3 months, then switch to 60 bpm for the next 3 months.
Primary Outcome Measure
Exercise tolerance as measured by the Six-Minute Walk Test [ Time Frame: 3 months ]
Central Contacts
- Sarahfaye Dolman302-530-1873
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | Athanasios Thomaides, MD |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | Athanasios Thomaides, MD |
| MedStar Union Memorial Hospital | Baltimore | Maryland | 21218 | Athanasios Thomaides, MD |
| MedStar Southern Maryland Hospital | Clinton | Maryland | 20735 | Athanasios Thomaides, MD |
| MedStar Heart and Vascular Office at Fairfax | Fairfax | Virginia | 22031 | Athanasios Thomaides, MD |