Trial Outcomes & Findings for Prospective Evaluation of CT Guided Ablation of Cardiac Ganglionated Plexi (NCT NCT04642976)

Results Overview

Number of patients with HFS response identified within 3 pixels (0.625x3=1.875mm) of a location where CT identified epicardial adipose tissue.

Recruitment status

COMPLETED

Target enrollment

30 participants

Primary outcome timeframe

During Procedure

Results posted on

2024-10-15

Participant Flow

Participant milestones

Participant milestones
Measure	Atrial Fibrillation Ablation All patients undergoing ablation with undergo pre-procedural CT as well as HFS mapping and ablation of GPs. Ganglionated Plexi mapping and ablation using Natus Cortical Stimulator and standard ablation catheters: Ganglionated plexi will be mapped using high frequency stimulation with standard ablation catheters attached to a Natus Cortical Stimulator for high frequency stimulation. Vagal innervation to the heart will be assessed with non-invasive Parasym tragal stimulation.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Atrial Fibrillation Ablation n=30 Participants All patients undergoing ablation with undergo pre-procedural CT as well as HFS mapping and ablation of GPs. Ganglionated Plexi mapping and ablation using Natus Cortical Stimulator and standard ablation catheters: Ganglionated plexi will be mapped using high frequency stimulation with standard ablation catheters attached to a Natus Cortical Stimulator for high frequency stimulation. Vagal innervation to the heart will be assessed with non-invasive Parasym tragal stimulation.
Age, Categorical <=18 years	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=30 Participants
Age, Categorical >=65 years	26 Participants n=30 Participants
Sex: Female, Male Female	15 Participants n=30 Participants
Sex: Female, Male Male	15 Participants n=30 Participants
Region of Enrollment United States	30 participants n=30 Participants

PRIMARY outcome

Timeframe: During Procedure

Number of patients with HFS response identified within 3 pixels (0.625x3=1.875mm) of a location where CT identified epicardial adipose tissue.

Outcome measures

Outcome measures
Measure	Atrial Fibrillation Ablation n=19 Participants All patients undergoing ablation with undergo pre-procedural CT as well as HFS mapping and ablation of GPs. Ganglionated Plexi mapping and ablation using Natus Cortical Stimulator and standard ablation catheters: Ganglionated plexi will be mapped using high frequency stimulation with standard ablation catheters attached to a Natus Cortical Stimulator for high frequency stimulation. Vagal innervation to the heart will be assessed with non-invasive Parasym tragal stimulation.
Correlation Between HFS (High Frequency Stimulation) Response and CT Identified Epicardial Adipose Tissue.	3 Number of patients with HFS response

SECONDARY outcome

Timeframe: during procedure

Elimination of local of HFS response following GP ablation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: This will be assessed during the procedure.

Elimination of global vagal response to non-invasive tragal stimulation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: This will be assessed during the procedure.

Characterization of amplitude signals at sites with HFS responses and successful HFS elimination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: This will be assessed during the procedure.

Characterization of duration of signals at sites with HFS responses and successful HFS elimination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: This will be assessed during the procedure.

Characterization of fractionation of signals at sites with HFS responses and successful HFS elimination

Outcome measures

Outcome data not reported

Adverse Events

Atrial Fibrillation Ablation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Timothy Markman

University of Pennsylvania

Phone: 215-615-4332

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place