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Tests treatment safety and results for AF - Atrial Fibrillation
Official title SAfety and eFfectiveness of cathetER Ablation for Atrial Fibrillation With Intracerebral Hemorrhage (SAFER-AF)
ClinicalTrials.gov ID: NCT07316270
What this study is testing
- What it's testing
- SAFER-AF is an investigator-initiated, multicenter, open-label, parallel-group trial comparing catheter ablation versus usual care in patients with atrial fibrillation and intracerebral hemorrhage.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Between 14 Days and 12 Months After Spontaneous Intracerebral Hemorrhage
- Able to Access Intracerebral Hemorrhage Imaging Data
- ECG indicating the presence of atrial fibrillation
- CHA₂DS₂-VA Score ≥ 2
You likely can't join if
- Atrial fibrillation secondary to clearly reversible causes (e.g., hyperthyroidism, hypokalemia, etc.)
- Fully dependent (modified Rankin Scale [mRS] score \> 4)
- Uncontrolled hypertension (systolic blood pressure \> 160 mmHg)
- Presence of uncontrolled active bleeding
- Presence of active infection requiring antibiotic treatment
- End-stage renal failure or receiving dialysis treatment
See the full eligibility criteria
- Age ≥ 18 years
- Between 14 Days and 12 Months After Spontaneous Intracerebral Hemorrhage
- Able to Access Intracerebral Hemorrhage Imaging Data
- ECG indicating the presence of atrial fibrillation
- CHA₂DS₂-VA Score ≥ 2
- Willing to undergo randomization and able to complete follow-up as required
- Atrial fibrillation secondary to clearly reversible causes (e.g., hyperthyroidism, hypokalemia, etc.)
- Fully dependent (modified Rankin Scale [mRS] score \> 4)
- Uncontrolled hypertension (systolic blood pressure \> 160 mmHg)
- Presence of uncontrolled active bleeding
- Presence of active infection requiring antibiotic treatment
- End-stage renal failure or receiving dialysis treatment
- Presence of liver failure
- Untreated coronary artery disease with indication for revascularization
- Presence of intracardiac masses, thrombi, etc., as evaluated by transthoracic echocardiography or transesophageal echocardiography
- Expected life expectancy \< 1 year (e.g., advanced malignant tumors, etc.)
- Pregnant, lactating, or women planning to become pregnant
- Presence of psychological or psychiatric disorders that prevent understanding or cooperation with the study
- Other conditions deemed unsuitable for participation in the study by the investigators
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Xiamen, Fujian, China
- Harbin, Heilongjiang, China
- Changchun, Jilin, China
- Xi'an, Shaanxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Xiamen, Fujian, China; Harbin, Heilongjiang, China; Changchun, Jilin, China; Xi'an, Shaanxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.