CClinicalTrials.gg
Status unknownNCT05173779Updated Aug 10, 2022

Left Atrial Isolation by Catheter Ablation in Persistent Atrial Fibrillation With Severe Atrial Fibrosis

An interventional study of Left atrial isolation by catheter ablation in Persistent Atrial Fibrillation, sponsored by Shanghai Chest Hospital. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-08-10.

Sponsored by Shanghai Chest Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
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Study summary

This is a single-arm clinical trial evaluating the efficacy and safety of left atrial isolation achieved by catheter ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.

Read the detailed description

This is a single-arm clinical trial. Patients with persistent atrial fibrillation with severe atrial fibrosis are enrolled as subjects to conduct left atrial isolation by catheter ablation. Postoperative recurrence rate and other indicators are analyzed to evaluate the efficacy and safety of left atrial isolation achieved by catheter ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.

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Conditions studied

  • Persistent Atrial Fibrillation

Keywords

  • Persistent Atrial Fibrillation
  • Severe atrial fibrosis
  • Left atrial isolation
  • catheter ablation
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In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's planned enrollment of 50 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Shanghai Chest Hospital is the lead sponsor of 194 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Aged 18 to 80 years old
  2. Persistent AF with severe atrial fibrosis and left atrial anterioposterior diameter > 50mm
  3. Nonresponse or intolerance to ≥1 antiarrhythmic drug
  4. CHA2DS2-VASc ≥ 3 and HAS-BLED \< 3

Exclusion criteria

Exclusion Criteria:

  1. With uncontrolled congestive heart failure;
  2. Having significant valvular disease;
  3. Having moderate-to-severe pulmonary hypertension;
  4. With myocardial infarction or stroke within 6 months of screening;
  5. With Significant congenital heart disease;
  6. Ejection fraction was \<40% measured by echocardiography;
  7. Allergic to contrast media;
  8. Contraindication to anticoagulation medications;
  9. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
  10. Left atrial thrombus;
  11. Having any contraindication to right or left sided heart catheterization
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Left atrial isolation arm

    All the enrolled subjects will receive left atrial isolation through catheter ablation.

    Procedure: Left atrial isolation by catheter ablation

Interventions

  • ProcedureLeft atrial isolation by catheter ablation

    Procedure: Right pulmonary vein circumferential isolation + anterior left atrial line (superior mitral annulus to right superior pulmonary vein via the anterior wall) + para-septal line (para-septal mitral annulus to the right inferior pulmonary vein, including right atrial components-especially in and around the proximal coronary sinus) + posterior left atrial line (superior mitral annulus to right superior pulmonary vein via the posterior wall).

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What researchers measure

Primary outcomes

  1. Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate

    AF/AFL/AT recurrence is defined as presence of documented AF/AFL/AT episodes of 30 seconds or longer duration

    Time frame: up to 18 months after enrollment

Secondary outcomes

  1. Postoperative AF recurrence rate

    AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration

    Time frame: up to 18 months after enrollment

  2. Postoperative AFL/AT rate

    Occurrence of AFL/AT is defined as presence of documented AFL/AT episodes of 30 seconds or longer duration

    Time frame: up to 18 months after enrollment

  3. Incidence of complications

    including death, atrio-esophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, diaphragmatic paralysis, pneumothorax, pleural effusion, heart block, pulmonary vein stenosis, pulmonary edema, left atrial thrombus, pericarditis and major vascular access complication or bleeding

    Time frame: up to 18 months after enrollment

  4. Changes in the diameter of the left atrium and the left ventricular ejection fraction

    Time frame: up to 18 months after enrollment

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05173779
Lead sponsor
Shanghai Chest Hospital
Responsible party
Xu Liu (Professor, deputy director of cardiology department of Shanghai Chest Hospital, Shanghai Chest Hospital) — Principal investigator
First posted
Dec 30, 2021
Start date
Jan 1, 2023 (estimated)
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Aug 10, 2022

Study contacts

Mu Qin, M.D.
Contact
qinmuae@163.com
+8613052320103

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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