Trial Outcomes & Findings for Stereotaxis Study To Obliterate Persistent Ventricular Tachycardia (NCT NCT00851279)

Last Updated: 2015-08-24

Results Overview

In order to qualify for inclusion in the chronic success statistic, patients must first be an acute success and must have had no VTs identified in their ICD history post ablation therapy.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

53 participants

Primary outcome timeframe

1 Year follow-up

Results posted on

2015-08-24

Participant Flow

Participant milestones

Participant milestones
Measure	Magnetic Irrigated Ablation Catheter Magnetic irrigated catheter for VT: Magnetic irrigated catheter to be used with the magnetic navigation system
Overall Study STARTED	53
Overall Study COMPLETED	53
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stereotaxis Study To Obliterate Persistent Ventricular Tachycardia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Magnetic Irrigated Ablation Catheter n=53 Participants Patients underwent ablation therapy using remote magnetic navigation, RMN (Niobe, Stereotaxis Inc.,St Louis, USA), and an irrigated RF ablation catheter (NaviStar RMT ThermoCool, Biosense Webster,California, USA).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	33 Participants n=5 Participants
Age, Continuous	67 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants
Region of Enrollment Czech Republic	32 participants n=5 Participants
Region of Enrollment Germany	9 participants n=5 Participants
Left Ventricular Ejection Fraction	31.5 percent n=5 Participants
History of cerebro-vascular accident (CVA)	9 participants n=5 Participants
History of transient ischemic attack (TIA)	3 participants n=5 Participants
History of diabetes	16 participants n=5 Participants
Pre-procedural arrhythmia treatment with beta-blockers	47 participants n=5 Participants
Pre-procedural arrhythmia treatment with amiodarone	34 participants n=5 Participants
ICD implanted prior to the ablation procedure	38 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Year follow-up

In order to qualify for inclusion in the chronic success statistic, patients must first be an acute success and must have had no VTs identified in their ICD history post ablation therapy.

Outcome measures

Outcome measures
Measure	Magnetic Irrigated Ablation Catheter n=53 Participants Either the transseptal or transaortic approach was employed to gain access for endocardial mapping/ablation during VT (entrainment mapping, activation mapping) and/or substrate mapping in sinus rhythm (elimination of fractionated/late potentials, endocardial scar homogenization) with RMN (Niobe, Stereotaxis Inc.,St Louis, USA) and irrigated RF ablation (NaviStar RMT ThermoCool, Biosense Webster,California, USA).
Percentage of Participants Free From VT at 1 Year Post-Treatment	62 percentage of participants free from VT

Adverse Events

Magnetic Irrigated Ablation Catheter

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

Dr Qun Sha, MD, Director of Clinical Trials

Stereotaxis Inc.

Phone: 314 678 6143

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60