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The purpose of this study is to demonstrate that the amount of effective CRT (Cardiac Resynchronization Therapy) pacing during AF (atrial fibrillation) when CAFRPlus (Conducted AF Response Plus) is applied is not inferior to the amount of effective CRT pacing during AF when CAFR (Conducted AF Response) is applied.
The CRTee study is an IDE, prospective, multi-center, randomized, controlled, crossover clinical study, conducted worldwide and designed to demonstrate that the amount of effective CRT pacing during AF (atrial fibrillation) when CAFRPlus (Conducted AF Response Plus) is applied is not inferior to the amount of effective CRT pacing during AF when CAFR (Conducted AF Response) is applied.
The study will be conducted at up to 30 centers located in the United States, Europe and Middle East and Africa (MEA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: CAFR first | Other | Subjects randomized to Group A will receive CAFR first, then cross over to CAFRPlus. |
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| Group B: CAFRPlus first | Other | Subjects randomized to Group B will receive CAFRPlus first, then cross over to CAFR. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conducted AF Response (CAFR) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Effective CRT Pacing During AF (Non-inferiority Test) | 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). | Up to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Effective CRT Pacing During AF (Superiority Test) | 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). | Up to 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suneet Mittal, MD | Valley Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiac Arrythmia Services | Boca Raton | Florida | United States | |||
| Iowa Heart Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29132930 | Derived | Plummer CJ, Frank CM, Bari Z, Al Hebaishi YS, Klepfer RN, Stadler RW, Ghosh S, Liu S, Mittal S. A novel algorithm increases the delivery of effective cardiac resynchronization therapy during atrial fibrillation: The CRTee randomized crossover trial. Heart Rhythm. 2018 Mar;15(3):369-375. doi: 10.1016/j.hrthm.2017.10.026. Epub 2017 Nov 11. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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| Conducted AF Response Plus (CAFRPlus) | Device | 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. |
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| West Des Moines |
| Iowa |
| United States |
| North Memorial Heart and Vascular | Minneapolis | Minnesota | United States |
| CentraCare | Saint Cloud | Minnesota | United States |
| North Carolina Heart and Vascular | Raleigh | North Carolina | United States |
| Mount Carmel | Columbus | Ohio | United States |
| Oklahoma Heart | Oklahoma City | Oklahoma | United States |
| Berks Cardiology | Reading | Pennsylvania | United States |
| Texas Cardiac Arrhythmia Services | Austin | Texas | 78705 | United States |
| Kootenai Heart Clinics | Spokane | Washington | United States |
| Magyar Honvédség Honvédkorház | Budapest | Hungary |
| Policlinico Universitario Agostino Gemelli | Roma | Italy |
| Azienda Ospedaliera Bolognini Seriate - Ospedale Bolognini | Seriate | Italy |
| Azienda Ospedaliera Cardinale Panico | Tricase | Italy |
| Prince Sultan Cardiac Center | Riyadh | Saudi Arabia |
| Vychodoslovensky ustav srdcovych a cievnych chorob, a.s. | Košice | Slovakia |
| Mediclinic Panorama | Cape Town | South Africa |
| Liverpool Heart and Chest Hospital NHS Foundation Trust | Liverpool | United Kingdom |
| he Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital | Newcastle upon Tyne | United Kingdom |
| FG001 | 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. |
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| NOT COMPLETED |
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| Period 2 |
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All subjects randomized to either Group A (CAFR first) or Group B (CAFRPlus first).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Gender | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Effective CRT Pacing During AF (Non-inferiority Test) | 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). | Randomized subjects who had paired measurements available from both CAFR period and CAFRPlus period. | Posted | Mean | Standard Deviation | percentage of effective CRT pacing | Up to 4 months |
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| Secondary | Percentage of Effective CRT Pacing During AF (Superiority Test) | 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). | Randomized subjects who had paired measurements available from both CAFR period and CAFRPlus period. | Posted | Mean | Standard Deviation | percentage of effective CRT pacing | Up to 4 months |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Enrolled Subjects | All subjects enrolled in the CRTee study. | 7 | 71 | 5 | 71 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Ventricular arrhythmia | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Death | General disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CRTee Clinical Team | Medtronic Cardiac Rhythm and Heart Failure | 800-328-2518 | MedtronicCRMtrials@medtronic.com |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Hungary |
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| United States |
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| Italy |
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| United Kingdom |
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| Slovakia |
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In order to demonstrate that CAFRPlus is no less effective than CAFR by a non-inferiority margin of 2%, assuming a true paired difference of 6% and a standard deviation of 15% for the paired differences, a sample size of 39 subjects with paired data is required to achieve 90% statistical power using the one-sample t-test for non-inferiority, while controlling the one-sided type I error rate at 0.025. |
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