Trial · NCT07910370
Structured Treatment and Resource Efficiency Assessment With Lean Six Sigma Integration for Pulmonary Vein Isolation
NCT07910370, Not applicable, Recruiting, St. Josefs-Hospital Wiesbaden GmbH
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Structured Treatment and Resource Efficiency Assessment With Lean Six Sigma Integration for Pulmonary Vein Isolation. Trials, record NCT07910370. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07910370
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Structured Treatment and Resource Efficiency Assessment With Lean Six Sigma Integration for Pulmonary Vein Isolation
- NCT number
- NCT07910370
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 94 participants, estimated
- Lead sponsor
- St. Josefs-Hospital Wiesbaden GmbH
- Conditions
- Atrial Fibrillation (AF)
- Interventions
- Pulsed Field Ablation (PFA), Cryoballoon Ablation (Cryo)
- First posted
- 2026-11-02
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Procedure Duration | During the ablation procedure | otal procedure duration, defined as the time from first vascular puncture to application of the venous compression bandage, measured in minutes. |
| Secondary | Time to Post-Anesthetic Recovery | Immediately after the ablation procedure until achievement of a score ≥9 | Time from application of the venous compression bandage to achievement of a Post-Anesthetic Recovery Score of ≥9 points, measured in minutes. |
| Secondary | Post-Anesthetic Recovery Score at 1 Hour | 1 hour after the ablation procedure | Post-Anesthetic Recovery Score assessed one hour after application of the venous compression bandage (range 0-10, higher scores indicating better recovery). |
| Secondary | Time to Same-Day Discharge Readiness | Starting 4 hours after the ablation procedure until discharge readiness | Time from application of the venous compression bandage to achievement of a Same-Day Readiness Score (SDRS) ≥8 points, indicating readiness for safe mobilization and discharge. |
| Secondary | Atrial Fibrillation/Atrial Tachycardia Burden | 12 months after ablation | Atrial fibrillation and atrial tachycardia burden assessed by rhythm monitoring during the 12-month follow-up period. |
| Secondary | Recurrence of Atrial Arrhythmias | Within 12 months after ablation | Proportion of patients experiencing documented atrial arrhythmia recurrence (AF, atrial flutter, or atrial tachycardia) lasting ≥30 seconds, including the 8-week blanking period. |
| Secondary | All-Cause Mortality | Within 12 months after ablation | Proportion of patients experiencing death from any cause during follow-up. |
| Secondary | Stroke or Transient Ischemic Attack | Within 12 months after ablation | Proportion of patients experiencing fatal or nonfatal stroke or transient ischemic attack (TIA). |
| Secondary | Cardiovascular Hospitalization | Within 12 months after ablation | Proportion of patients requiring hospitalization for cardiovascular causes during follow-up. |
| Secondary | Procedure-Related Complications | Within 30 days after ablation | Proportion of patients experiencing procedure-related complications, including death, stroke/TIA, major bleeding (BARC ≥2), major vascular complications, pericardial effusion or tamponade, systemic embolism, phrenic nerve injury, atrio-esophageal fistula, hemolysis, nosocomial infections requiring hospitalization, or coronary spasm. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07910370
GET https://conductscience.org/api/trials/v1/NCT07910370/registered