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Trial · NCT07889440

Registered outcomes19

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryAnatomical Zone of the Effective Coronary Sinus RF ApplicationDuring the index ablation procedure
Anatomical location of the first epicardial radiofrequency (RF) application within the coronary sinus that is temporally associated with achievement of bidirectional mitral isthmus conduction block. Unit: categorical variable (Superior, Anterior, Inferior, or Posterior zone).
PrimaryRF Power of the Effective Coronary Sinus RF ApplicationDuring the index ablation procedureRF power delivered during the first epicardial coronary sinus RF application that is temporally associated with achievement of bidirectional mitral isthmus conduction block. Unit: Watts (W).
PrimaryDuration of the Effective Coronary Sinus RF ApplicationDuring the index ablation procedureDuration of the first epicardial coronary sinus RF application that is temporally associated with achievement of bidirectional mitral isthmus conduction block. Unit: seconds (s).
PrimaryContact Force of the Effective Coronary Sinus RF ApplicationDuring the index ablation procedureMean contact force recorded during the first epicardial coronary sinus RF application that is temporally associated with achievement of bidirectional mitral isthmus conduction block. Unit: grams (g).
PrimaryAblation Index of the Effective Coronary Sinus RF ApplicationDuring the index ablation procedureAblation Index value of the first epicardial coronary sinus RF application that is temporally associated with achievement of bidirectional mitral isthmus conduction block.
PrimaryCumulative Epicardial RF Time to Mitral Isthmus BlockDuring the index ablation procedure
Total cumulative duration of epicardial coronary sinus RF applications delivered up to and including the first application associated with achievement of bidirectional mitral isthmus conduction block. Unit: seconds (s).
PrimaryRelative Order of the Effective Coronary Sinus RF ApplicationDuring the index ablation procedureSequence number of the first epicardial coronary sinus RF application that is temporally associated with achievement of bidirectional mitral isthmus conduction block. Unit: lesion number (n).
SecondaryNumber of Epicardial Coronary Sinus RF ApplicationsDuring the index ablation procedureTotal number of epicardial radiofrequency (RF) applications delivered within the coronary sinus during the ablation procedure. Unit: number of RF applications (n).
SecondaryDistribution of Epicardial Coronary Sinus RF ApplicationsDuring the index ablation procedureNumber of epicardial RF applications delivered within each of the 8 predefined anatomical coronary sinus zones. Unit: number of RF applications per anatomical zone (n).
SecondaryCumulative Epicardial Coronary Sinus RF TimeDuring the index ablation procedureTotal cumulative duration of all epicardial RF applications delivered within the coronary sinus. Unit: seconds (s).
SecondaryTotal Procedure RF TimeDuring the index ablation procedureTotal duration of radiofrequency energy delivery during the entire ablation procedure. Unit: seconds (s).
SecondaryTotal Fluoroscopy TimeDuring the index ablation procedureTotal fluoroscopy time during the ablation procedure. Unit: minutes (min).
SecondaryTotal Procedure DurationDuring the index ablation procedureTotal duration of the ablation procedure. Unit: minutes (min).
SecondaryAchievement of Bidirectional Mitral Isthmus Block Without Epicardial Coronary Sinus AblationDuring the index ablation procedure
Proportion of procedures in which bidirectional mitral isthmus (MI) conduction block is achieved without delivery of epicardial RF applications within the coronary sinus. Unit: percentage of procedures (%).
SecondaryNumber of Coronary Sinus RF Applications According to VOM-EI SuccessDuring the index ablation procedure
Difference in the total number of epicardial coronary sinus RF applications between procedures with successful Vein of Marshall ethanol infusion (VOM-EI) and procedures with failed or absent VOM-EI. Unit: number of RF applications (n).
SecondaryDistribution of Coronary Sinus RF Applications According to VOM-EI SuccessDuring the index ablation procedure
Difference in the distribution of epicardial coronary sinus RF applications across the 8 predefined anatomical zones between procedures with successful VOM-EI and procedures with failed or absent VOM-EI. Unit: number of RF applications per anatomical zone (n).
SecondaryCumulative Epicardial RF Time According to VOM-EI SuccessDuring the index ablation procedureDifference in cumulative epicardial coronary sinus RF time between procedures with successful VOM-EI and procedures with failed or absent VOM-EI. Unit: seconds (s).
SecondaryTime to Mitral Isthmus Block According to VOM-EI SuccessDuring the index ablation procedureDifference in time to achievement of bidirectional mitral isthmus conduction block between procedures with successful VOM-EI and procedures with failed or absent VOM-EI. Unit: seconds (s).
SecondaryIncidence of Periprocedural ComplicationsDuring the index ablation procedure
Incidence of periprocedural complications related to mitral isthmus ablation, epicardial coronary sinus RF ablation, or Vein of Marshall ethanol infusion (VOM-EI), including pericardial effusion or cardiac tamponade, coronary sinus dissection or perforation, coronary artery injury or spasm, stroke or transient ischemic attack (TIA), phrenic nerve palsy, steam pop, and complications specifically related to VOM-EI. Unit: percentage of participants with at least one periprocedural complication (%).

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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