Trial Outcomes & Findings for TactiCath® Contact Force Ablation Catheter Study for Atrial Fibrillation Post Approval Study (NCT NCT02310100)

Last Updated: 2021-10-12

Results Overview

Rate of subjects free from symptomatic Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter (AFL), and Atrial Tachycardia (AT) lasting longer than 30 seconds through 9 months of follow-up after a 3 month blanking period compared to a stated performance goal. Procedural failure defined by any of the following events: (1) Documented recurrence of AF/AFL/AT during the 9-month observational period lasting longer than 30 seconds; (2) Repeat ablation following the blanking period; or (3) Use of s new anti-arrhythmic drug for the documented symptomatic atrial arrhythmia following the blanking period.

Recruitment status

COMPLETED

Study phase

Target enrollment

178 participants

Primary outcome timeframe

12 Months post ablation

Results posted on

2021-10-12

Participant Flow

109 subjects were directly enrolled into the TactiCath PAS 50 subjects rolled over from the TactiCath Continued Access Protocol 19 subjects rolled over from the TOCCASTAR Supplemental Study The first subject was enrolled on January 21, 2015 and the last subject on January 29, 2016. All enrollment was from sites within the United States.

Only subjects that met all inclusion criteria and did not meet any exclusion criteria were enrolled in the study.

Participant milestones

Participant milestones
Measure	TactiCath Quartz Patients undergoing elective catheter ablation for symptomatic paroxysmal AF that was refractory or intolerant to at least one Class I-IV antiarrhythmic drug
Overall Study STARTED	178
Overall Study COMPLETED	160
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Reasons for withdrawal
Measure	TactiCath Quartz Patients undergoing elective catheter ablation for symptomatic paroxysmal AF that was refractory or intolerant to at least one Class I-IV antiarrhythmic drug
Overall Study Physician Decision	3
Overall Study Withdrawal by Subject	10
Overall Study Enrollment closure	1
Overall Study Unapproved ablation operator	1
Overall Study Visit compliance	1
Overall Study Lost to Follow-up	2

Baseline Characteristics

2 subjects had missing data for sex

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TactiCath Quartz n=178 Participants Ablation with TactiCath Quartz
Age, Continuous	62.7 years STANDARD_DEVIATION 10.5 • n=178 Participants
Sex: Female, Male Sex · Female	73 Participants n=176 Participants • 2 subjects had missing data for sex
Sex: Female, Male Sex · Male	103 Participants n=176 Participants • 2 subjects had missing data for sex
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=178 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	176 Participants n=178 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=178 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=178 Participants
Race (NIH/OMB) Asian	2 Participants n=178 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=178 Participants
Race (NIH/OMB) Black or African American	1 Participants n=178 Participants
Race (NIH/OMB) White	172 Participants n=178 Participants
Race (NIH/OMB) More than one race	0 Participants n=178 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=178 Participants
Region of Enrollment United States	178 participants n=178 Participants

PRIMARY outcome

Timeframe: 12 Months post ablation

Population: Subjects who terminated the study prematurely before experiencing a treatment failure were not considered a treatment success at 12-months. Subjects who terminated the study for reasons clearly unrelated to the study device were also excluded and not considered treatment failures.

Outcome measures

Outcome measures
Measure	TactiCath Quartz n=165 Participants Ablation using TactiCath Quartz
Number of Participants Free From Recurrent, Symptomatic Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter (AFL), and Atrial Tachycardia (AT)	111 Participants

PRIMARY outcome

Timeframe: 7 days

Population: The analysis population includes all subjects in whom a study device was introduced.

The rate of device or procedure serious adverse events occurring within 7 days of the index procedure or hospital discharge, whichever is later, compared to a stated performance goal.

Outcome measures

Outcome measures
Measure	TactiCath Quartz n=173 Participants Ablation using TactiCath Quartz
Number of Participants Experiencing a Device or Procedure-related Serious Adverse Event	14 Participants

Adverse Events

TactiCath Quartz

Serious events: 14 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TactiCath Quartz n=173 participants at risk Ablation with TactiCath Quartz
Surgical and medical procedures Vascular access complication	2.9% 5/173 • Number of events 5 • 2 years -NOTE: 5 subjects withdrew before the TactiCath Quartz catheter was introduced into the body resulting in a denominator of 173 in this section. Investigators reported all AEs except for the following: * Exacerbation of pre-existing non-CV conditions * Physical trauma unrelated to the procedure * New disease unrelated to AF, the procedure, or study device/CV drugs * Common ailments unrelated to the CV system, the procedure, study device or drugs used to treat CV illness
Cardiac disorders Cardiac perforation/tamponade	2.3% 4/173 • Number of events 4 • 2 years -NOTE: 5 subjects withdrew before the TactiCath Quartz catheter was introduced into the body resulting in a denominator of 173 in this section. Investigators reported all AEs except for the following: * Exacerbation of pre-existing non-CV conditions * Physical trauma unrelated to the procedure * New disease unrelated to AF, the procedure, or study device/CV drugs * Common ailments unrelated to the CV system, the procedure, study device or drugs used to treat CV illness
General disorders Hospitalization	2.3% 4/173 • Number of events 4 • 2 years -NOTE: 5 subjects withdrew before the TactiCath Quartz catheter was introduced into the body resulting in a denominator of 173 in this section. Investigators reported all AEs except for the following: * Exacerbation of pre-existing non-CV conditions * Physical trauma unrelated to the procedure * New disease unrelated to AF, the procedure, or study device/CV drugs * Common ailments unrelated to the CV system, the procedure, study device or drugs used to treat CV illness
Cardiac disorders Pericardial effusion	0.58% 1/173 • Number of events 1 • 2 years -NOTE: 5 subjects withdrew before the TactiCath Quartz catheter was introduced into the body resulting in a denominator of 173 in this section. Investigators reported all AEs except for the following: * Exacerbation of pre-existing non-CV conditions * Physical trauma unrelated to the procedure * New disease unrelated to AF, the procedure, or study device/CV drugs * Common ailments unrelated to the CV system, the procedure, study device or drugs used to treat CV illness
Cardiac disorders Pericarditis	0.58% 1/173 • Number of events 1 • 2 years -NOTE: 5 subjects withdrew before the TactiCath Quartz catheter was introduced into the body resulting in a denominator of 173 in this section. Investigators reported all AEs except for the following: * Exacerbation of pre-existing non-CV conditions * Physical trauma unrelated to the procedure * New disease unrelated to AF, the procedure, or study device/CV drugs * Common ailments unrelated to the CV system, the procedure, study device or drugs used to treat CV illness
General disorders Allergic drug reaction that required intubation	0.58% 1/173 • Number of events 1 • 2 years -NOTE: 5 subjects withdrew before the TactiCath Quartz catheter was introduced into the body resulting in a denominator of 173 in this section. Investigators reported all AEs except for the following: * Exacerbation of pre-existing non-CV conditions * Physical trauma unrelated to the procedure * New disease unrelated to AF, the procedure, or study device/CV drugs * Common ailments unrelated to the CV system, the procedure, study device or drugs used to treat CV illness
Cardiac disorders Sinus bradycardia	0.58% 1/173 • Number of events 1 • 2 years -NOTE: 5 subjects withdrew before the TactiCath Quartz catheter was introduced into the body resulting in a denominator of 173 in this section. Investigators reported all AEs except for the following: * Exacerbation of pre-existing non-CV conditions * Physical trauma unrelated to the procedure * New disease unrelated to AF, the procedure, or study device/CV drugs * Common ailments unrelated to the CV system, the procedure, study device or drugs used to treat CV illness

Other adverse events

Other adverse events
Measure	TactiCath Quartz n=173 participants at risk Ablation with TactiCath Quartz
General disorders Chest pain	4.6% 8/173 • Number of events 8 • 2 years -NOTE: 5 subjects withdrew before the TactiCath Quartz catheter was introduced into the body resulting in a denominator of 173 in this section. Investigators reported all AEs except for the following: * Exacerbation of pre-existing non-CV conditions * Physical trauma unrelated to the procedure * New disease unrelated to AF, the procedure, or study device/CV drugs * Common ailments unrelated to the CV system, the procedure, study device or drugs used to treat CV illness
General disorders Other	8.1% 14/173 • Number of events 14 • 2 years -NOTE: 5 subjects withdrew before the TactiCath Quartz catheter was introduced into the body resulting in a denominator of 173 in this section. Investigators reported all AEs except for the following: * Exacerbation of pre-existing non-CV conditions * Physical trauma unrelated to the procedure * New disease unrelated to AF, the procedure, or study device/CV drugs * Common ailments unrelated to the CV system, the procedure, study device or drugs used to treat CV illness
Cardiac disorders Pericarditis	4.6% 8/173 • Number of events 8 • 2 years -NOTE: 5 subjects withdrew before the TactiCath Quartz catheter was introduced into the body resulting in a denominator of 173 in this section. Investigators reported all AEs except for the following: * Exacerbation of pre-existing non-CV conditions * Physical trauma unrelated to the procedure * New disease unrelated to AF, the procedure, or study device/CV drugs * Common ailments unrelated to the CV system, the procedure, study device or drugs used to treat CV illness

Additional Information

Lori Rusch, Ph.D.

Abbott

Phone: 1-651-756-2668

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place