Trial Outcomes & Findings for Therapy Cool Path Ablate VT (NCT NCT00925522)

NCT ID: NCT00925522

Last Updated: 2019-04-17

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 7 days
• Results posted on: 2019-04-17

Participant Flow

Patients with atrial flutter are evaluated by ablation doctor in the EP clinic and assessed for possibility of meeting other inclusion criteria.

This is a non-randomized study.

Participant milestones

Measure	Therapy Cool Path Duo Cardiac Ablation System Therapy Cool Path Duo Cardiac Ablation System: Consists of following three system components: A flexible, insulated 7F all braided catheter that contains an internal lumen connected to 12 open conduits at the 4mm tip electrode for infusion of heparinized saline during radiofrequency ablation; records intracardiac electrograms and can be utilized for cardiac simulation during diagnostic electrophysiologic studies/evaluation. The 1500T9-VT generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The Generator will be used in Temperature Control mode only. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode. The Cool Point ™ Irrigation Pump and Cool Point™ Tubing Set is an external volumetric pump that is intended for use in administration of general I.V. fluids to patient's vascular system through the cat
Overall Study STARTED	20
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Measure

Therapy Cool Path Duo Cardiac Ablation System Therapy Cool Path Duo Cardiac Ablation System: Consists of following three system components: A flexible, insulated 7F all braided catheter that contains an internal lumen connected to 12 open conduits at the 4mm tip electrode for infusion of heparinized saline during radiofrequency ablation; records intracardiac electrograms and can be utilized for cardiac simulation during diagnostic electrophysiologic studies/evaluation. The 1500T9-VT generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The Generator will be used in Temperature Control mode only. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode. The Cool Point ™ Irrigation Pump and Cool Point™ Tubing Set is an external volumetric pump that is intended for use in administration of general I.V. fluids to patient's vascular system through the cat

Overall Study study closed -- business decision

20

Baseline Characteristics

Therapy Cool Path Ablate VT

Baseline characteristics by cohort

Measure	Therapy Cool Path Duo Cardiac Ablation System n=20 Participants Therapy Cool Path Duo Cardiac Ablation System: Consists three system components: A flexible, insulated 7F all braided catheter that contains an internal lumen connected to 12 open conduits at the 4mm tip electrode for infusion of heparinized saline during radiofrequency ablation; records intracardiac electrograms and can be utilized for cardiac simulation during diagnostic electrophysiologic studies/evaluation. The 1500T9-VT generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The Generator will be used in Temperature Control mode only. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode. The Cool Point ™ Irrigation Pump and Cool Point™ Tubing Set is an external volumetric pump that is intended for use in administration of general I.V. fluids.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	66.8 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days

Outcome measures

Measure	Therapy Cool Path Duo Catheter n=20 Participants All patients received RF (radio frequency) therapy from ablation catheter.
Primary Safety is Defined as the Incidence of Intra-procedural, Acute or Sub-chronic, Serious Cardiac Adverse Events, up to 7 Days Post-procedure.	7 participants

Adverse Events

Therapy Cool Path Duo Cardiac Ablation System

Serious events: 7 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	Therapy Cool Path Duo Cardiac Ablation System n=20 participants at risk Therapy Cool Path Duo Cardiac Ablation System: Consists of: A flexible, insulated 7F all braided catheter that contains an internal lumen connected to 12 open conduits at the 4mm tip electrode for infusion of heparinized saline during radiofrequency ablation; records intracardiac electrograms and can be utilized for cardiac simulation during diagnostic electrophysiologic studies/evaluation. The 1500T9-VT generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The Generator will be used in Temperature Control mode only. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode. The Cool Point ™ Irrigation Pump and Cool Point™ Tubing Set is an external volumetric pump that is intended for use in administration of general I.V. fluids to patient's vascular system through the catheter in the hospital environment.
Cardiac disorders Arrhythmia(s) including AFL, AF or VT	25.0% 5/20 • Number of events 5 • 6 months Definition of AEs and SAEs per clinicaltrials.gov were used
Cardiac disorders Congestive Heart Failure	5.0% 1/20 • Number of events 1 • 6 months Definition of AEs and SAEs per clinicaltrials.gov were used
Cardiac disorders Hypotension	5.0% 1/20 • Number of events 1 • 6 months Definition of AEs and SAEs per clinicaltrials.gov were used
Cardiac disorders Cardiac Effusion without Tamponade	5.0% 1/20 • Number of events 1 • 6 months Definition of AEs and SAEs per clinicaltrials.gov were used
Cardiac disorders Cardiac Effusion with Tamponade	10.0% 2/20 • Number of events 2 • 6 months Definition of AEs and SAEs per clinicaltrials.gov were used

Other adverse events

Measure	Therapy Cool Path Duo Cardiac Ablation System n=20 participants at risk Therapy Cool Path Duo Cardiac Ablation System: Consists of: A flexible, insulated 7F all braided catheter that contains an internal lumen connected to 12 open conduits at the 4mm tip electrode for infusion of heparinized saline during radiofrequency ablation; records intracardiac electrograms and can be utilized for cardiac simulation during diagnostic electrophysiologic studies/evaluation. The 1500T9-VT generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The Generator will be used in Temperature Control mode only. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode. The Cool Point ™ Irrigation Pump and Cool Point™ Tubing Set is an external volumetric pump that is intended for use in administration of general I.V. fluids to patient's vascular system through the catheter in the hospital environment.
Cardiac disorders Hypotension	15.0% 3/20 • Number of events 3 • 6 months Definition of AEs and SAEs per clinicaltrials.gov were used
Cardiac disorders Hypertension	15.0% 3/20 • Number of events 3 • 6 months Definition of AEs and SAEs per clinicaltrials.gov were used
Cardiac disorders Arrythmia	10.0% 2/20 • Number of events 2 • 6 months Definition of AEs and SAEs per clinicaltrials.gov were used
Blood and lymphatic system disorders Infection	5.0% 1/20 • Number of events 1 • 6 months Definition of AEs and SAEs per clinicaltrials.gov were used
Cardiac disorders Chest Pains Palpitations	10.0% 2/20 • Number of events 3 • 6 months Definition of AEs and SAEs per clinicaltrials.gov were used
Psychiatric disorders Anxiety/Depression	5.0% 1/20 • Number of events 1 • 6 months Definition of AEs and SAEs per clinicaltrials.gov were used
Cardiac disorders CHF symptoms	10.0% 2/20 • Number of events 3 • 6 months Definition of AEs and SAEs per clinicaltrials.gov were used
Nervous system disorders Sleep Apnea	5.0% 1/20 • Number of events 1 • 6 months Definition of AEs and SAEs per clinicaltrials.gov were used
Blood and lymphatic system disorders Hyperlipidemia	5.0% 1/20 • Number of events 1 • 6 months Definition of AEs and SAEs per clinicaltrials.gov were used

Additional Information

Nancy Ouch, Project Manager

St. Jude Medical

Phone: 949.769.5041

Email: nouch@sjm.com

Results disclosure agreements

• Principal investigator is a sponsor employee Approval from St. Jude Medical prior to any publication.
• Publication restrictions are in place

Restriction type: OTHER