Trial Outcomes & Findings for EnSite Precision Observational Study (NCT NCT03260244)

NCT ID: NCT03260244

Last Updated: 2024-11-08

Results Overview

The number and proportion of subjects with acute success will be summarized. Acute success was defined as the physician's goal or intention for the procedure.

• Recruitment status: COMPLETED
• Target enrollment: 1065 participants
• Primary outcome timeframe: during procedure
• Results posted on: 2024-11-08

Participant Flow

Participant milestones

Measure	All Subjects All subjects enrolled in the study.
Overall Study STARTED	1065
Overall Study Treated	925
Overall Study 1-month Follow up	898
Overall Study 6-month Follow up	765
Overall Study 12-month Follow up	722
Overall Study COMPLETED	779
Overall Study NOT COMPLETED	286

Reasons for withdrawal

Measure	All Subjects All subjects enrolled in the study.
Overall Study Death	19
Overall Study Lost to Follow-up	60
Overall Study Withdrawal by Subject	48
Overall Study Procedure Not Performed	21
Overall Study Enrollment Criteria Not Met	31
Overall Study Procedure Not Performed Per Protocol	12
Overall Study Subject Noncompliance	6
Overall Study No inducible Arrhythmia	2
Overall Study Procedure Not Performed by Trained Physician on Study	2
Overall Study Screen Failure	2
Overall Study Treated Off Label	69
Overall Study No Radiofrequency Ablation	14

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	All Subjects n=925 Participants All subjects enrolled in the study.
Age, Continuous	64.3 years STANDARD_DEVIATION 11.6 • n=925 Participants
Sex: Female, Male Female	279 Participants n=925 Participants
Sex: Female, Male Male	646 Participants n=925 Participants
Region of Enrollment United States	751 Participants n=925 Participants
Region of Enrollment Canada	174 Participants n=925 Participants

PRIMARY outcome

Timeframe: during procedure

Population: Analysis Population, number of subjects ablated per study protocol

The number and proportion of subjects with acute success will be summarized. Acute success was defined as the physician's goal or intention for the procedure.

Outcome measures

Measure	All Subjects n=925 Participants All subjects enrolled in the study.
Rate of Acute Success Based on Pre-defined Procedural Endpoints	901 Participants

PRIMARY outcome

Timeframe: From date of procedure until the date of first documented arrhythmia recurrence or date of study completion or withdrawal for any cause, whichever came first, assessed up to 12 months

Population: Subjects who completed the 12-month visit post-procedure

This analysis will be performed using the Kaplan-Meier (KM) analyses. The start date is the date of the index procedure. For subjects who do not experience an event, their follow up duration will be defined from the start date to the date of death, withdrawal, or last follow-up, whichever occurred later.

Outcome measures

Measure	All Subjects n=722 Participants All subjects enrolled in the study.
Freedom From Arrhythmia Recurrence	471 Participants

Adverse Events

All Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 20 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Associate Director, Clinical Research, Electrophysiology

Abbott

Phone: 651-756-3813

Email: anne.sarver@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee The data and results from the clinical investigation are the sole property of the Sponsor. The Investigators will not use this clinical investigation-related data without the written consent of the Sponsor for any purpose other than for clinical investigation completion or for generation of publication materials, as referenced in the Clinical Trial Agreement. Single-center results are not allowed to be published or presented before the multi-center results.
• Publication restrictions are in place

Restriction type: OTHER