Trial Outcomes & Findings for Cardiac Resynchronization Therapy Efficacy Enhancements (NCT NCT02222818)
NCT ID: NCT02222818
Last Updated: 2017-01-06
Results Overview
The primary objective is to demonstrate that the percent effective CRT pacing during AF when CAFRPlus is applied is not inferior to when CAFR is applied (non-inferiority test).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
71 participants
Primary outcome timeframe
Up to 4 months
Results posted on
2017-01-06
Participant Flow
A total of 71 subjects were enrolled from 22 investigational centers in the United States, Europe and Middle East. The first subject was enrolled on 07 Oct 2014, and last enrollment was on 08 Jan 2016.
Of the 71 enrolled subjects, 5 did not meet eligibility criteria (AV node ablation - 2, complete heart block - 3) and were exited from the study prior to randomization assignment.
Participant milestones
| Measure |
Group A: CAFR First
Subjects randomized to Group A will receive CAFR first, then cross over to CAFRPlus.
Conducted AF Response (CAFR): The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.
Conducted AF Response Plus (CAFRPlus): The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing.
|
Group B: CAFRPlus First
Subjects randomized to Group B will receive CAFRPlus first, then cross over to CAFR.
Conducted AF Response (CAFR): The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.
Conducted AF Response Plus (CAFRPlus): The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing.
|
|---|---|---|
|
Period 1
STARTED
|
33
|
33
|
|
Period 1
COMPLETED
|
33
|
30
|
|
Period 1
NOT COMPLETED
|
0
|
3
|
|
Period 2
STARTED
|
33
|
30
|
|
Period 2
COMPLETED
|
33
|
30
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group A: CAFR First
Subjects randomized to Group A will receive CAFR first, then cross over to CAFRPlus.
Conducted AF Response (CAFR): The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.
Conducted AF Response Plus (CAFRPlus): The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing.
|
Group B: CAFRPlus First
Subjects randomized to Group B will receive CAFRPlus first, then cross over to CAFR.
Conducted AF Response (CAFR): The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.
Conducted AF Response Plus (CAFRPlus): The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing.
|
|---|---|---|
|
Period 1
Eligibility criteria not met
|
0
|
3
|
Baseline Characteristics
Cardiac Resynchronization Therapy Efficacy Enhancements
Baseline characteristics by cohort
| Measure |
Group A: CAFR First
n=33 Participants
Subjects randomized to Group A will receive CAFR first, then cross over to CAFRPlus.
Conducted AF Response (CAFR): The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.
Conducted AF Response Plus (CAFRPlus): The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing.
|
Group B: CAFRPlus First
n=33 Participants
Subjects randomized to Group B will receive CAFRPlus first, then cross over to CAFR.
Conducted AF Response (CAFR): The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.
Conducted AF Response Plus (CAFRPlus): The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.7 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
72.4 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
71.6 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Gender
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Gender
Male
|
29 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Region of Enrollment
Saudi Arabia
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
17 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 4 monthsPopulation: Randomized subjects who had paired measurements available from both CAFR period and CAFRPlus period.
The primary objective is to demonstrate that the percent effective CRT pacing during AF when CAFRPlus is applied is not inferior to when CAFR is applied (non-inferiority test).
Outcome measures
| Measure |
CAFR ON
n=54 Participants
Percentage of effective CRT pacing during AF when CAFR is ON
|
CAFRPlus ON
n=54 Participants
Percentage of effective CRT pacing during AF when CAFRPlus is ON
|
|---|---|---|
|
Percentage of Effective CRT Pacing During AF (Non-inferiority Test)
|
80.8 percentage of effective CRT pacing
Standard Deviation 14.3
|
87.8 percentage of effective CRT pacing
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: Up to 4 monthsPopulation: Randomized subjects who had paired measurements available from both CAFR period and CAFRPlus period.
The secondary objective is to demonstrate that the percent effective CRT pacing during AF when CAFRPlus is applied is greater than when CAFR is applied (superiority test).
Outcome measures
| Measure |
CAFR ON
n=54 Participants
Percentage of effective CRT pacing during AF when CAFR is ON
|
CAFRPlus ON
n=54 Participants
Percentage of effective CRT pacing during AF when CAFRPlus is ON
|
|---|---|---|
|
Percentage of Effective CRT Pacing During AF (Superiority Test)
|
80.8 percentage of effective CRT pacing
Standard Deviation 14.3
|
87.8 percentage of effective CRT pacing
Standard Deviation 7.8
|
Adverse Events
All Enrolled Subjects
Serious events: 7 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Enrolled Subjects
n=71 participants at risk
All subjects enrolled in the CRTee study.
|
|---|---|
|
Cardiac disorders
Cardiac failure
|
2.8%
2/71 • Number of events 3 • Adverse event data were collected throughout entire study follow-up (from enrollment to study exit). Subjects' follow-up duration ranged from 0 to 5.4 months, with an average of 2.7 ± 1.6 months for all enrolled subjects.
|
|
Cardiac disorders
Ventricular arrhythmia
|
2.8%
2/71 • Number of events 2 • Adverse event data were collected throughout entire study follow-up (from enrollment to study exit). Subjects' follow-up duration ranged from 0 to 5.4 months, with an average of 2.7 ± 1.6 months for all enrolled subjects.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.4%
1/71 • Number of events 1 • Adverse event data were collected throughout entire study follow-up (from enrollment to study exit). Subjects' follow-up duration ranged from 0 to 5.4 months, with an average of 2.7 ± 1.6 months for all enrolled subjects.
|
|
General disorders
Death
|
1.4%
1/71 • Number of events 1 • Adverse event data were collected throughout entire study follow-up (from enrollment to study exit). Subjects' follow-up duration ranged from 0 to 5.4 months, with an average of 2.7 ± 1.6 months for all enrolled subjects.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.4%
1/71 • Number of events 1 • Adverse event data were collected throughout entire study follow-up (from enrollment to study exit). Subjects' follow-up duration ranged from 0 to 5.4 months, with an average of 2.7 ± 1.6 months for all enrolled subjects.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
1.4%
1/71 • Number of events 1 • Adverse event data were collected throughout entire study follow-up (from enrollment to study exit). Subjects' follow-up duration ranged from 0 to 5.4 months, with an average of 2.7 ± 1.6 months for all enrolled subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.4%
1/71 • Number of events 1 • Adverse event data were collected throughout entire study follow-up (from enrollment to study exit). Subjects' follow-up duration ranged from 0 to 5.4 months, with an average of 2.7 ± 1.6 months for all enrolled subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.4%
1/71 • Number of events 1 • Adverse event data were collected throughout entire study follow-up (from enrollment to study exit). Subjects' follow-up duration ranged from 0 to 5.4 months, with an average of 2.7 ± 1.6 months for all enrolled subjects.
|
Other adverse events
| Measure |
All Enrolled Subjects
n=71 participants at risk
All subjects enrolled in the CRTee study.
|
|---|---|
|
Cardiac disorders
Cardiac failure
|
7.0%
5/71 • Number of events 5 • Adverse event data were collected throughout entire study follow-up (from enrollment to study exit). Subjects' follow-up duration ranged from 0 to 5.4 months, with an average of 2.7 ± 1.6 months for all enrolled subjects.
|
Additional Information
CRTee Clinical Team
Medtronic Cardiac Rhythm and Heart Failure
Phone: 800-328-2518
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Generally, contracts allow investigators to publish study results per the protocol and publication plan. Investigators and Participating Institutions will provide any publication of Study Data generated by PI and/or Participating Institution to Medtronic for review prior to submission to determine if confidential information ("CI") is included and to check for technical correctness. Medtronic may not censor/interfere with the publication beyond the extent necessary to protect CI.
- Publication restrictions are in place
Restriction type: OTHER