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NCT06969118
RCT of Minimalist vs Standard Procedure for LAAC in NVAF Patients
NA trial testing Minimalism Transcatheter LAAC Group in Atrial Fibrillation in 200 participants. Not yet recruiting.
1 June 2027
Quick facts
| Lead sponsor | Shanghai Zhongshan Hospital |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 200 |
| Start date | 1 June 2025 |
| Primary completion | 1 June 2027 |
| Estimated completion | 1 June 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- Minimalism Transcatheter LAAC Group
- Standard Transcatheter LAAC Group
Conditions studied
- Atrial Fibrillation — all drugs for Atrial Fibrillation →
- Left Atrial Appendage Occlusion — all drugs for Left Atrial Appendage Occlusion →
- General Anesthesia — all drugs for General Anesthesia →
- Local Anesthesia — all drugs for Local Anesthesia →
Sponsor
Shanghai Zhongshan Hospital
Who can join
Adults 18 to 85, any sex, with Atrial Fibrillation or Left Atrial Appendage Occlusion. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Percutaneous left atrial appendage closure (LAAC) is an effective strategy for stroke prevention in patients with non-valvular atrial fibrillation (NVAF). Standard procedure requires general anesthesia, transesophageal echocardiography (TEE) guidance. With the experience accumulation, LAAC can be successfully completed in many centers under local anesthesia, the guidance of X-ray and transthoracic echocardiography (TTE), also known as minimalist procedure. Our center was one of the earliest to carry out minimalist procedure worldwide. At present, expert consensus suggests that minimalist procedure is feasible in experienced centers, but the relevant evidence is insufficient. Some single-arm studies have shown that minimalist procedure is safe and effective. However, there is currently a lack of direct evidence to compare the strengths and weaknesses of these two LAAC procedures. The goal of the study was to compare the effectiveness and safety of minimalist procedure and standard procedure for LAAC in patients with NVAF.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06969118
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06969118 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Zhongshan Hospital
- Last refreshed: 13 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06969118.
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