Trials / Completed
CompletedNCT05827172
AF Ablation for HF With Reduced EF
Catheter Ablation vs. Medical Treatment in Patients With HFrEF and Persistent AF (CAEFR-AF)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 96 (actual)
- Sponsor
- Shanghai Chest Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This is an open label, multi-center, randomized parallel control clinical trial, to examining thethe clinical outcomes of AF ablation on HFrEF patients with persistent atrial fibrillation.
Detailed description
This is an open label, multi-center, randomized parallel control clinical trial. HFrEF patients with persistent atrial fibrillation are 1:1 randomized into the AF ablation group or the medical therapy (rate or rhythm control) group. Markers of HFrEF severity, including composite of death from any cause or worsening of heart failure that led to an unplanned overnight hospitalization,exercise hemodynamics, natriuretic peptide levels, and patient symptoms. and other indicators are analyzed to demonstrate the role of AF ablation in comparing the effects of AF ablation vs usual medical therapy for HFrEF patients with persistent atrial fibrillation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | AF ablation | The aim of the ablation procedure was to achieve isolation of all pulmonary veins and to restore sinus rhythm.Additional ablation strategies were made at the discretion of the operators. |
| OTHER | medical therapy | The medical therapy for atrial fibrillation was administered in accordance with the guidelines that were available at the time of the trial.Efforts to maintain sinus rhythm were recommended. The aim of the treatment was a ventricular rate of 60 to 80 beats per minute at rest. |
Timeline
- Start date
- 2020-06-01
- Primary completion
- 2021-12-31
- Completion
- 2023-01-31
- First posted
- 2023-04-24
- Last updated
- 2023-04-24
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05827172. Inclusion in this directory is not an endorsement.