Trial Outcomes & Findings for Catheter Evaluation for Endocardial Ablation in Patients With Typical Atrial Flutter (NCT NCT00318565)

Last Updated: 2012-03-05

Results Overview

Acute success is defined as the confirmation of complete bidirectional conduction block across the subeustachian (cavo-tricuspid) isthmus. The percentage of subjects with confirmed conduction block will serve as the outcome measure.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

291 participants

Primary outcome timeframe

During the procedure

Results posted on

2012-03-05

Participant Flow

First subject enrollment on June 7, 2006 Last subject enrolled August 14, 2007. Enrollment rate was 20.5 subjects per month across 21 hospitals

Participant milestones

Participant milestones
Measure	Ablation Group Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
Overall Study STARTED	291
Overall Study COMPLETED	267
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Ablation Group Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
Overall Study Excluded per protocol	24

Baseline Characteristics

Catheter Evaluation for Endocardial Ablation in Patients With Typical Atrial Flutter

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ablation Group n=291 Participants Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	136 Participants n=5 Participants
Age, Categorical >=65 years	155 Participants n=5 Participants
Age Continuous	65.2 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants
Sex: Female, Male Male	243 Participants n=5 Participants
Region of Enrollment United States	291 participants n=5 Participants

PRIMARY outcome

Timeframe: During the procedure

Population: Per protocol analysis. Number differs from "Participant Flow" because only 253 subjects were considered for the efficacy cohort.

Outcome measures

Outcome measures
Measure	Ablation Group n=253 Participants Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
Percentage of Subjects With Complete Bidirectional Conduction Block.	93.3 percentage of participants Interval 90.1 to 100.0

PRIMARY outcome

Timeframe: 7 Days

The cardiovascular specific adverse event (CSAE) rate is the primary safety enpoint for the study. A CSAE is an event which occurs within the first week (7 days) following use of the device and is one of the following cardiac specific adverse events: cardiac perforation, pericardial effusion, pulmonary embolus, complete heart block, stroke, acute myocardial infarction, and death.

Outcome measures

Outcome measures
Measure	Ablation Group n=267 Participants Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
Percentage of Subjects Experiencing Cardiovascular Specific Adverse Events (CSAE) Within Seven (7) Days of the Ablation Procedure.	1.5 percentage of participants Interval 0.0 to 3.4

Adverse Events

Ablation Group

Serious events: 4 serious events

Other events: 73 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ablation Group n=267 participants at risk Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolus	0.37% 1/267 • Number of events 1
Cardiac disorders Complete Heart Block	0.75% 2/267 • Number of events 2
Cardiac disorders Acute myocardial infarction	0.37% 1/267 • Number of events 1

Other adverse events

Other adverse events
Measure	Ablation Group n=267 participants at risk Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
General disorders Adverse Events within 7 Days- Device Related	0.37% 1/267 • Number of events 1
General disorders Adverse Events within 7 Days- Possibly Device Related	0.00% 0/267
General disorders Adverse Events within 7 Days- Procedure Related	6.7% 18/267 • Number of events 21
General disorders Adverse Events within 7 Days- Possibly Procedure Related	4.5% 12/267 • Number of events 12
General disorders Adverse Events within 7 Days- Unrelated to Device or Procedure	9.0% 24/267 • Number of events 29
General disorders Adverse Events Greater than 7 Days- Device Related	0.00% 0/267
General disorders Adverse Events Greater than 7 Days- Possibly Device Related	0.00% 0/267
General disorders Adverse Events Greater than 7 Days- Procedure Related	0.75% 2/267 • Number of events 2
General disorders Adverse Events Greater than 7 Days- Possibly Procedure Related	0.00% 0/267
General disorders Adverse Events Greater than 7 Days- Unrelated to Device or Procedure	10.5% 28/267 • Number of events 30

Additional Information

Christine Liu

Biosense Webster

Phone: 9098398608

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place