Trials / Completed
CompletedNCT02145351
Efficacy Study of Pacemakers to Treat Slow Heart Rate in Patients With Heart Failure
Rate-Adaptive Atrial Pacing In Diastolic Heart Failure (RAPID-HF)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Determine the impact of restoring normal heart rate response during exercise and daily activity in patients with heart failure and a preserved ejection fraction (HFpEF) and chronotropic incompetence (CI).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Rate adaptive atrial pacing using a dual-chamber pacemaker | The Azure XT DR is a permanent, dual-chamber cardiac pacemaker with the ability to continuously monitor and record patient activity, and respond to activity by pacing faster and increasing the heart rate (rate adaptive atrial pacing). It will be programmed in AAIR mode to pace the right atrium. The leads will be placed in the right atrium and right ventricle using CapSureFix model 5086. |
| DEVICE | Pacemaker system will be implanted but set to Pacing Off. | The identical pacing system will be implanted, but will be set to Pacing Off. |
Timeline
- Start date
- 2014-04-07
- Primary completion
- 2022-05-09
- Completion
- 2022-05-09
- First posted
- 2014-05-22
- Last updated
- 2023-04-05
- Results posted
- 2023-04-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02145351. Inclusion in this directory is not an endorsement.